Obstetrics and Periodontal Therapy (opt) Study Manual of Operations Version 1 March 3, 2003 Brief Table of Contents



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II.Subject's Path


PART II.
A SUBJECT'S PATH THROUGH THE STUDY

II.1. Recruitment, Consent, and Enrollment into the Study
II.1.1. Initial Contact and Recruitment
II.1.1.1. Procedures. Each potential subject will go through the pre-screening informed consent, provided by either the study coordinator or treatment hygienist, except at the Kentucky site. For the Kentucky site only, there will be no formal pre-screen examination. Instead, at Kentucky, the OB clinic will inform all newly pregnant women that as a part of their OB care, a dental examination is being recommended. The OB PI or resident will call the Study Coordinator or Periodontal PI to inform them that a new patient is in the clinic and has agreed to receive a dental exam. The potential subject will be told that the dental examination is free of charge. Upon examination, if it appears that the new patient will be eligible for the study, the Study Coordinator or trained staff member will explain the study and determine if the woman would like to go through the process of enrollment.
Subjects will be recruited in the obstetrics clinics of the Enrollment Sites. The Recruitment Visit consists of these steps:
• A potential subject makes a pre-natal visit to the clinic, usually her first, and is determined to be pregnant.

• A resident physician takes her history according to the Site's standard procedure.

• The potential subject has an ultrasound to determine gestational age.

• If the resident physician and the results of the ultrasound determine that the potential subject is less than 16 weeks 6 days pregnant, the resident physician directs the potential subject to the Recruitment Hygienist.

• The Recruitment Hygienist (or Study Coordinator) briefly explains the goals of the study, determines the potential subject's interest, and obtains her consent to conduct a brief periodontal assessment (Pre-Screening Consent Form).
After the potential subject signs the consent form for the pre-screening, the Recruitment Hygienist performs a brief examination to assess whether she is likely to meet the study's eligibility criteria. Specifically, the Recruitment Hygienist determines whether the potential subject appears to meet these three criteria:
• At least 20 natural teeth (including crowns but excluding dentures and implants).*

• Four (4) or more teeth having at least one site with probing depth 4 mm or greater and clinical attachment loss 2 mm or greater.



• Bleeding on probing at 25% or more of tooth sites.
This examination is not intended to be the definitive determination of eligibility, but rather a quick screen to eliminate most ineligible potential subjects. Accordingly, no measurements are recorded for this examination.
If the potential subject fails to meet one of the three eligibility criteria indicated above, the Recruitment Hygienist tells her that she is ineligible for the study and thanks her for her participation.
If the potential subject passes the pre-screening and wishes to enroll, the Recruitment Hygienist refers her to the Study Coordinator who solicits her further participation.
If the potential subject's gestational age is 13weeks 0 days to 16 weeks 6 days, an appropriately trained staff member obtains informed consent, enrolls her, and schedules the Baseline/Randomization Visit (Visit 1). Details of these steps are in the sections immediately following this one.
If the potential subject's gestational age is less than 13 weeks, an appropriately trained staff member obtains informed consent, enrolls her, and schedules the Baseline/Randomization Visit (Visit 1) after the potential subject's 13th week. Details of these steps are in the sections immediately following this one.
Recruitment Visit and Baseline/Randomization Visit (Visit 1) on the same day. Some subjects will be able to have their Baseline/Randomization Visit (Visit 1) the same day that they enroll, so that the Recruitment Visit and the Baseline/Randomization Visit (Visit 1) occur on the same day. If both visits can be completed on the same day, this should be done because it saves the subject a trip to the clinic and saves the study a gift certificate. There are two exceptions. First, if the potential subject's gestational age has not been determined from the results of her ultrasound scan, then her eligibility cannot be established. In such cases, the potential subject can be enrolled but her Baseline/Randomization Visit (Visit 1) cannot take place until the results of her ultrasound scan are available. The second exception will occur at the Kentucky site where the subject may not have an ultrasound until the 18th week of gestation. In this case, the subject can still be randomized if her gestational age is appropriate in the judgment of the physician based on the subject’s menstral history. Forms 10 and 04 will be filled out to reflect this (see below, Section II.1.3.6 (Form 10) and Section II.2.4.4 (Form 4)), and the randomization will result in an automatic error correction indicating a need for an ultrasound. If the subject is subsequently determined by ultrasound dating to have been outside the allowable gestational age at the time of randomization and/or it is determined that the woman has multiple fetuses per ultrasound, the subject is ineligible and her data cannot be used to answer the main study question. Despite this error, because the subject has already been randomized, Essential Dental Care and any treatment will be continued, although plaque and serum samples will not be collected.
If a subject cannot complete the Baseline/Randomization procedures at that time she is enrolled, the Study Coordinator will schedule an appointment for the Baseline/Randomization Visit (Visit 1), which must occur between the 13th and 16th weeks of gestation. See Section II.2.2, "Timing of the Baseline/Randomization Visit (Visit 1)" for more specifics.
Determination of gestational age. In all cases, the potential subject must undergo an ultrasound to determine gestational age. In addition, the resident physician may determine gestational age from the potential subject's menstrual history. In some cases, gestational age will not be well-determined without the ultrasound examination. In these cases, the potential subject can be enrolled if in the resident physician's judgment she is between 13 and 16 weeks pregnant. However, with the exception of the Kentucky site, she cannot be randomized until the results of the ultrasound are available and she is determined to be eligible.
The OPT trial will use the Maternal-Fetal Medicine Unit (MFMU, defined by NICHD) criteria for determination of gestational age, as follows:


  1. If the last menstrual period (LMP) is not certain, the ultrasound measurements obtained at the patient’s first ultrasound examination should be used to determine the study gestational age and estimated date of conception (EDC).

  2. If the LMP date is certain and the ultrasound confirms this gestational age within the number of days specified in the table below, the LMP derived gestational age is used to determine the study gestational age and EDC.

  3. If the ultrasound determined age does not confirm the LMP generated gestational age within the number of days specified in the table below, the ultrasound is used to determine the study gestational age and EDC.


Cutoffs for Using LMP to Determine

Gestational Age
Gestational Age at Ultrasound


First Ultrasound by LMP

Agreement with LMP

Up to 196 weeks

 7 days

200 weeks to 296 weeks

 14 days

300 weeks or more

 21 days



Subjects who withdraw consent after enrolling and before randomization. Some subjects will be recruited, consented, and enrolled but will withdraw consent before randomization or will turn out to be ineligible for randomization. It is required to keep enrollment information for these women and transmit it to the Data Coordinating Center (DCC) so the investigators can describe the subject population that was enrolled as well as the subset of enrollees that were randomized. This information is collected on Form 04 (Randomization/Exclusion); see Section II.2 "The Baseline/Randomization Visit (Visit 1)", below.
II.1.1.2. Recruitment Log (Form 00). The Recruitment Hygienist keeps a log of the women screened, using Form 00 (Recruitment Log), depicted below. This form is not to be sent to the DCC for keying. Rather, when the main study paper is written, summaries of this log will be used to describe subjects who were recruited but not enrolled or randomized.
E
ach potential subject examined by the Recruitment Hygienist gets her own line on Form 00.
Number: Fill this blank with the next number in sequence, i.e., begin with 1 (one) and increase by 1 (one) for each new potential subject.
Date: Enter the date on which the Recruitment Hygienist examined the subject.
Race/Ethnicity: check any race or ethnicity category that the subject considers appropriate. More specific race/ethnicity information is recorded on the Enrollment Form (Form 01). Subjects should report on their race and ethnicity. The race/ethnicity of the potential subject should not be determined by the study staff. If the subject is of Hispanic ethnicity, you must indicate a specific race as well as indicating Hispanic ethnicity. Thus, if a patient is Black Hispanic, two boxes (Black and Hispanic) should be checked.
Disposition: This item indicates whether the potential subject appeared to be eligible, and if so, whether she decided to enroll. If the potential subject is deemed ineligible, check "Not eligible". Indicate the specific reason the subject was not eligible. This information will be utilized for reporting of all women that were screened for study eligibility. If the subject is not eligible for a medical or other reason, not related to periodontal exclusion criteria, indicate the reason on the “other” section. If the potential subject is deemed eligible but does not wish to enroll, check "Declined to enroll". If the subject is deemed eligible and wishes to enroll, check "Referred to Study Coord."
Names of potential subjects should NOT be written on Form 00, not even nicknames or first names.
II.1.2. Informed consent for enrollment in the study
The Study Coordinator (or appropriately trained staff member) performs the formal process of obtaining the pre-screen consent as well as consent for enrollment in the study. Failure to obtain informed consent and a signed consent form from each subject before enrollment is a serious protocol violation.
Before a potential subject is given the full consent form, the Study Coordinator must discuss the nature of the study, randomization, blinding, study procedures, the importance of compliance to study procedures, potential risks and benefits, and the duration of the study. The potential subject must be told that she is not obligated to participate, that there will be no penalty for declining to participate, and that treatment will not be compromised if patients do not participate or cease participation at any time.
Potential subjects must then be given ample time to read and understand the form and to ask questions. If the potential subject cannot read for any reason, clinic staff must read the consent form aloud to her. Clinic staff should use appropriate sensitivity when administering the consent form, for example, they should not ask the subject if she can read, but rather should ask whether she would prefer to have the consent form read to her or to read it herself. Clinic staff may choose to provide an audio-tape of the consent form to potential subjects who cannot read. The audio tape should record a clear-voiced person reading the consent form at a reasonable speed. If the potential subject cannot understand English, then the consent process must be administered in the subject's language or translated by an interpreter, in the presence of the Study Coordinator.
After the subject signs the consent form, a signed copy is given to the patient for her records. A second signed copy is kept by Study Coordinator in a locked cabinet with other confidential patient information.
II.1.3. Procedures for Enrollment into the Study: Enrollment form (Form 01), Patient Locator Information (Form 02), Patient Log (Form 03), Patient Tracking Form (Form 06), Baseline Obstetric Data (Form 10), Payment, and Transmittal to the Data Coordinating Center.
After the subject has consented, the Study Coordinator should complete these forms, for which detailed instructions are given below:
• Enrollment Form (Form 01);

• Patient Locator Information (Form 02);

• Patient Log (Form 03);

• Patient Tracking (Form 06) and;



• Baseline Obstetric Data (Form 10).
II.1.3.1. Patient ID (PID), Enrollment Code, and Labels. Before enrollment begins, the Data Coordinating Center (DCC) will send to each site provisional labels intended for use at the Recruitment Visit and the Baseline/Randomization Visit (Visit #1). Specifically, the Study Coordinator should receive a sheet of provisional labels for each possible patient ID (PID; described in the next paragraph), and the sheets will be sorted in order of the PIDs. Once a subject has been randomized, the DCC will send the Study Coordinator permanent labels that are specific to the subject. These permanent labels, specific to the subject, should be used for all subsequent visits.
The patient ID number (PID) has five digits followed by a dash followed by another digit, in the format XYYYY-Z. The first digit X identifies the clinical site, with 1 = New York, 2 = Minneapolis, 3 = Lexington, Kentucky, and 4 = Jackson, Mississippi. The next four digits YYYY are a number between 0 and 9999 and should be assigned to potential subjects sequentially. The last digit Z is computed from the first five and provides a check against transcription and other errors, on those occasions when a PID must be transcribed.
Each subject is also given an Enrollment Code, which is easier to remember than the PID and provides a second check against errors. The Enrollment code has the format XYY, where "X" is the first letter of the subject's surname or family name, and YY are the last two digits of her four-digit birth year. Thus, if a subject named Betty Shabazz was born in 1969, her enrollment code would be S69. The Enrollment Code is on the permanent labels but not on the provisional labels.
II.1.3.2. Enrollment Form (Form 01)
T
his form assigns to the subject a Patient ID number (PID) and records the Enrollment Code and some other basic information.
• The Site Coordinator assigns a PID to a subject by taking the next sheet of PID labels, which should contain the next PID in sequence. The Coordinator sticks the PID label to the appropriate spot in the upper right-hand corner of the form.
• Next, the Coordinator fills in the other fields in the upper right-hand corner of the form. "Clinical Unit" should be "NY" for New York, "MN" for Minneapolis, "KY" for Lexington, Kentucky, and "MS" for Jackson, Mississippi. The redundancy with the first digit of the PID provides another check against errors.
• The Enrollment code is the first letter of the subject's surname or family name, followed by the last two digits of her four-digit birth year. Thus, if a subject named Betty Shabazz was born in 1969, her enrollment code would be S69.
• Item 3, Race/Ethnicity: Note the distinctions in each of the race/ethnicity categories. The potential subject should tell the Coordinator all of the appropriate selections that apply.
• Item 4 provides a way to check the effectiveness of different recruiting methods. More than one item can be checked, as appropriate.

II.1.3.3. Patient Locator Information (Form 02)

F
orm 02's purpose is to help Enrollment Site personnel maintain contact with subjects.


The one exception is information about the subject's regular dentist, if she has one. If the subject is randomized, her regular dentist is sent a letter describing her participation in the study (see Section II.2.4.7, "Schedule appointments for Essential Dental Care").
Form 02 should be filled out by the Site Coordinator with the subject present, completing all sections for which the subject is willing and able to provide information. This form should be updated at each visit until the subject has completed the study.
Form 02 should not be sent to the Data Coordinating Center (DCC), as that would allow DCC personnel to associate personal identifiers with the Patient ID (PID), a violation of confidentiality.
II.1.3.4. Patient Log (Form 03)

The Patient Log (Form 03) is intended to help the Site Coordinator keep track of all subjects who have been enrolled and the subset that have been randomized. It provides a check to ensure that the Patient ID (PID) numbers are, in fact, being assigned sequentially and are not being reused accidentally.


E

Page 1 January 10, 2003

OBSTETRICS AND PERIODONTAL THERAPY STUDY
Participant ID Assignments: Kentucky

Enrollment Coordinator

Patient ID Code Date Enrolled (mm-dd-yyyy) Code Date Randomized (mm-dd-yyyy)

---- ---------- ---------- -------------------------- ----------- ----------------------------

1. 10001-8 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


2. 10002-6 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


3. 10003-4 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


4. 10004-2 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


5. 10005-9 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


6. 10006-7 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


7. 10007-5 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


8. 10008-3 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


9. 10009-1 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


10. 10010-9 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|


11. 10011-7 - - - - - - - - - - - - - - - - - - - - -

|_|-|_|_| |_|_|-|_|_|-|_|_|_|_| |_|_| |_|_| -|_|_| -|_|_|_|_|

OPT DCC, Minneapolis, MN

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ach time a new subject is enrolled, the Site Coordinator should enter their sequential number in the left-most blank, the date, the PID, the enrollment code, and the initials of the person who enrolled the patient.
Later, if the patient is eligible and is randomized, the box "Yes" should be checked under the heading "Randomized?”, while if the patient is not randomized, the box "No" should be checked.
II.1.3.5. Patient Tracking Form (Form 06)
T
he patient tracking form is intended for use by the Study Coordinator for tracking of visits and other relevant patient contact information. This form is to be completed only for subjects that have been enrolled and randomized.
The Study Coordinator will file this form in order of due date of the next upcoming visit in a locked file cabinet. The due date on the form should match the computer generated visit schedule produced by the DCC after randomization. The Coordinator should use this form for scheduling, tracking and confirming upcoming visits.
Following the randomization of a subject, a visit schedule will be mailed from the DCC to each site coordinator. This schedule will be used as a tool to compare the Visit Due Date information on Form 06 with the actual windows of time (dates) that the subject should be seen for each visit. It is important that subjects are seen during the appropriate time window for each visit. If the subject is not seen in the specified time window, the visit is counted as a missed visit. For more information on missed visits, see section II.5.3.4, “ Late and Missed Visits.”
Form 06 should not be sent to the Data Coordinating Center (DCC), as that would allow DCC personnel to associate personal identifiers with the Patient ID (PID), a violation of confidentiality.

I.1.3.6. Baseline Obstetric Data (Form 10)


The Study Coordinator should complete this form at enrollment. It collects information needed for assessing eligibility and information about risk factors for pre-term birth.


Most of the information needed for this form should come from the clinic's standard medical history form. In some cases, however, the standard medical history will not provide enough detail for some items, for example, for alcohol and tobacco consumption. For these items, the Site Coordinator should obtain the needed information directly from the subject.

Item A. 5, "May the patient be placed at medical risk by participating?" should be completed based on the judgment of the resident who examined the potential subject, supplemented by the Obstetrical Investigator as deemed necessary by the resident and Obstetrical Investigator. For example, infective endocarditis or certain hematological disorders would preclude routine non-surgical periodontal therapy and would be sufficient grounds for exclusion. If in doubt, the safer course is to exclude the subject.


• For some subjects, gestational age may be uncertain or unknown because of an unclear menstrual history. The Study Coordinator may nonetheless enroll the subject if, in the examining resident physician's judgment, the subject's gestational age is probably 13 to 16 weeks, as required. In such cases, the Study Coordinator should indicate that the ultrasound has not yet been completed (Item A.2), leave gestational age (Item A. 4) blank and enroll the subject. By the time the subject comes in for the Baseline/Randomization Visit (Visit #1), the subject's ultrasound scan will be available and her gestational age will be determined. At that point, if the Study Coordinator has not yet sent the subject's Form 10 to the Data Coordinating Center (DCC), s/he can simply fill in the gestational age, thereby completing the form (except for some subjects enrolled at the Kentucky site, for whom ultrasounds will not be performed until 18 weeks). If the Study Coordinator has sent the subject's Form 10 to the DCC, the missing gestational age will generate an error correction request from the DCC and the Study Coordinator should transmit the gestational age to the DCC in response to this error correction request. For more information on error corrections, see section III.15, "Data Management and Error Correction".
II.1.3.7. Dispense Gift Certificate
At the end of this visit, the Study Coordinator should give the enrolled subject a gift certificate for $20 from Target, WalMart, or similar store, as the incentive payment for the visit. Each enrolled subject will also receive a small infant toy (rattle/teether) for each visit. Procedures for managing and accounting for the gift certificates are described in Section III.12, "Incentive Payments (Gift Certificates)".
II.1.3.8. Transmit documents to the Data Coordinating Center (DCC)
After the subject is enrolled, the following forms should be sent to the DCC in the weekly forms shipment: Form 01 (Enrollment) and Form 10 (Baseline Obstetric Data). The Study Coordinator should make copies of all forms being sent to the DCC. The original is sent to the DCC and the copy is filed in the subject’s chart. The following forms should not be sent to the DCC: Form 02 (Patient Locator Information), Form 03 (Patient Log) and Form 06 (Patient Tracking Information) -- see Section III.7 ("Maintaining Confidentiality") for the rationale.
Section III.14 "Data Collection Procedures" describes how to send forms.
II.2. The Baseline/Randomization Visit (Visit 1)
II.2.1. Purpose
The purposes of the Baseline/Randomization visit (Visit 1) are to:
• perform the Baseline Oral Examination,

• obtain baseline medication data,

• obtain periodontal measurements,

• establish subject eligibility,

• take the baseline plaque and serum samples,

• perform the randomization, if the subject is eligible, and

• schedule appointments for Essential Dental Care and study periodontal therapy,

as appropriate.


II.2.2. Timing of the Baseline/Randomization Visit (Visit 1)
The Baseline/Randomization visit (Visit 1) must occur during the subject's 13th, 14th, 15th, or 16th week of pregnancy (gestational age). For subjects who have their recruitment visit and are enrolled during this interval, the Baseline/Randomization Visit (Visit 1) should be scheduled as soon as possible after the recruitment visit. If a subject does not have her Baseline/Randomization visit (Visit 1) before the end of her 16th week, she must not be randomized. If she is, this will be considered a protocol violation. Subjects who are enrolled before 13 weeks gestation must not receive their baseline periodontal examination or be randomized before they reach the beginning of their 13th week of pregnancy.
II.2.3. Scheduling and Preparing for the Baseline Visit
This visit will require approximately one hour. During this hour, the subject must undergo a brief oral examination and a periodontal examination, the Study Coordinator must establish whether she is eligible, have plaque and serum samples drawn and perform the randomization, if appropriate, and schedule appointments for Essential Dental Care and study periodontal therapy, as appropriate.
Therefore, this visit must occur at a time when the Treatment Blinded Calibrated Periodontal Examiner is available, the Enrolling Site's hematology lab is open, and the Data Coordinating Center can be reached on their toll-free line to perform a randomization, between 8:00 AM and 4:00 PM Central Time.
II.2.4. Sequence of Procedures and Forms, including the Randomization
This sequence of steps is followed for all subjects:
• perform the Baseline Oral Exam,

• perform the periodontal exam, Form 11 (Periodontal Measurements),

• determine eligibility, Form 04 (Randomization/Exclusion) and

• take the plaque sample, and record the sampled sites Form 11 (Periodontal

Measurements).
If the subject is ineligible, the Study Coordinator dispenses her final gift certificate and thanks her for participating. If the subject is eligible, the Study Coordinator performs these six steps:
• record the subject's current medications (Form 12, Medications),

• accompany the subject to the lab for a blood draw for the serum sample,

• randomize the subject, Form 04 (Randomization/Exclusion),

• schedule an appointment for Essential Dental Care, and if appropriate, schedule an appointment for study periodontal therapy,

• dispense her gift certificate and thanks her, and

• begin the subject's Event Checklist (Form 05).


These steps will now be described in greater detail.
II.2.4.1. Baseline Oral Exam.

The Baseline Oral Exam is performed by the Treatment Blinded Calibrated Periodontal Examiner, assisted by a Dental Assistant, supervised by the General Dentist.


The Baseline Oral Exam includes an evaluation of the intra- and extra-oral soft tissues and a screen for gross caries and fractured or abscessed teeth. As part of the soft tissue exam, the examiner should evaluate the lips and cheeks, buccal mucosa, hard and soft palate, floor of mouth, tongue and alveolar ridges. The examiner should also palpate the perioral lymph nodes to determine any tenderness or swelling. Care should be taken to identify any periodontal or dentoalveolar swellings or fistulae. Subjects who present with obvious dental pathoses will be referred to the general dentist for a comprehensive evaluation, treatment plan and essential dental care.
No radiographs will be taken at this exam, although radiographs may be taken for diagnostic purposes when randomized subjects receive Essential Dental Care.
No study data will be collected regarding the Baseline Oral Exam. Instead, each Enrollment Site will use its institution's standard forms and standard practices for recording and treatment planning. These records will be used:
• To provide Essential Dental Care after randomization. See Section II.3 ("Essential Dental Care") for details about Essential Dental Care.

• Along with the history taken at the recruitment visit, to determine whether the patient requires antibiotic prophylaxis for the periodontal examination and whether the patient may be placed at medical risk by participating in the study. Section II.2.4.2 (just below) describes how these items are recorded on study forms.


II.2.4.2. Periodontal Exam, Form 11 (Periodontal Measurements).
T
he periodontal exam, like the Baseline Oral Exam (section II.2.4.1), is performed by the Treatment Blinded Calibrated Periodontal Examiner, assisted by a Dental Assistant.

Periodontal measurements are recorded on Form 11 (Periodontal Measurements). Details of these measurements are given below.

Before the periodontal exam, the Site Coordinator should attach the subject's PID label in the upper right corner of page 1 and complete the other identifying information below it. This visit is Visit #1.

Next, under the heading "Answer these questions at baseline only" are two questions that affect the subject's eligibility for randomization: Does the subject require antibiotic prophylaxis for the periodontal exam?, and May the subject be placed at medical risk by participating in the study? Each of these questions should be answered based on the history and Baseline Oral Examination and on the clinician's judgment. Conditions that would imply "yes" answers include but are not limited to:


• previous infective endocarditis;

• prosthetic cardiac valves, including bioprosthetic and homografts;

• complex cyanotic congenital heart disease;

• surgically constructed systemic pulmonary shunts;

• most congential cardiac malformations;

• rheumatic heart disease or other acquired valvular dysfunctions;

• hypertrophic cardiomyopathy;

• mitral valve prolapse with regurgitation and/or thickened leaflets;

• joint prosthesis, placed less than two years ago;

• uncontrolled or poorly controlled diabetes;

• unstable angina;

• serious medical illness such as renal or liver disease;

• hematologic disease or other uncontrolled bleeding disorder;

• recent (within 6 months) myocardial infarction or stroke; or

• active infectious disease such as tuberculosis or hepatitis.
If in doubt, the clinician should err on the side of caution and answer "yes", which will make the subject ineligible for randomization.
The main body of both pages of this form contain a standard periodontal recording chart. Items in the periodontal chart are measured in this order:
1. Plaque Index from 6 surfaces of the 6 Ramfjord Index teeth

2. Gingival Index from 6 surfaces of all teeth

3. Pocket depth from 6 surfaces of all teeth

4. CEJ·GM from 6 surfaces of all teeth

5. Bleeding on probing from 6 surfaces of all teeth

6. Calculus Index from 6 surfaces of the 6 Ramfjord Index teeth


Section III.1, "Periodontal Measurements" gives detailed criteria for the indices, conventions for measuring pocket depth and clinical attachment level, and the convention for recording bleeding on probing. For items recorded on all teeth -- that is, the gingival index, pocket depth, CEJ·GM, and bleeding on probing, but not the plaque and calculus indices -- data items should be left blank for missing teeth. Missing teeth should be indicated by placing an “X” at the appropriate location on Form 11. All measurements are recorded in whole numbers, that is, without fractions or decimal places.
At baseline visits, the Treatment Blinded Calibrated Periodontal Examiner records summary descriptions of the patient's periodontal health based on the periodontal charting that was just completed, at the bottom of page 2 of Form 11 (Periodontal Measurements) under the heading "Answer these questions at baseline only". These data will be used to determine eligibility.
• Item c records the number of natural teeth present, including crowns but excluding dentures or implants.
• Item d records the number of sites at which periodontal measurements were made, and will generally be 6 times the number of teeth present. The correct number of sites is the number of sites for which bleeding upon probing was assessed; that is for which BOP was 0 or 1.
II.2.4.3. Plaque Sampling, Form 11 (Periodontal Measurements), continued.
Plaque samples are collected by the Treatment Blinded Calibrated Periodontal Examiner. Subgingival plaque samples are collected from four sites, which are re-sampled at Visit 5. The four sites are chosen accounting for all of these criteria:
• All plaque-sampling sites bled on probing

• No more than one plaque-sampling site is on any one tooth

• Subject to the preceding two criteria, the sites have the largest pocket depth (PD)

possible and are as posterior in the mouth as possible.


Sites meeting these criteria can be selected using this algorithm:
• Identify and list the n sites with the largest PD measurements. Depending on the subject, n should be 10 to 15 sites.

• Delete from the list any sites that did not bleed on probing.

• If any tooth has more than one site still on the list, retain the site on that tooth having the largest PD and delete the others. In case of ties, retain the most posterior site among the tied sites.

• From the sites remaining on the list, select the four with the largest PD measurements. If a choice must be made among sites with the same PD, choose the site(s) that are most posterior in the mouth.


Having selected the four sites for sampling, record those sites on Form 11 using the boxes in the lower left corner of page 2. For each sampled site, record the tooth number in the Universal system (numbered 1 to 32), the side of the tooth (buccal or lingual), and the site on that side of the tooth (mesial, direct/mid, or distal).
Plaque samples should be collected after clinical measurements have been taken, and before any scaling and root planing, polishing, or flossing. Before sampling the plaque, remove supragingival plaque at the selected sites with a curette or scaler. Do NOT use an ultrasonic device to remove the supragingival plaque. The supragingival plaque should be discarded. Then take a sterile curette and remove all subgingival plaque from the designated pocket; use the same curette for each site. To ensure that the entire pocket is sampled, review the pocket depth measure at that site and gently push the curette tip apically until it reaches the approximate base of the pocket. Open the plaque collection tube, and dislodge the plaque into the sample collection buffer. Because plaque is sticky, it may be necessary to repeatedly tap the curette against the side of the collection vial– be careful not to spill the contents of the tube. For some sites, it may be necessary to repeatedly curette the contents of the pocket until all of the plaque has been removed and archived. Plaque from the four sampled sites should be placed in the same tube. Close the collection tube as soon as possible.
Tubes may be thawed to room temperature prior to collection in order to affix the labels. It is recommended that labels be put on the tubes before plaque is collected in insure adhesion. Tubes containing plaque samples must be kept on ice from the moment of collection. Plaque samples are placed on ice to ensure 1) bacteria will stay inactive, and not produce enzymes like DNAases that might influence the results by degrading sample DNA, and 2) that species do not grow by degrading others. Keeping plaque samples on ice will also reduce variability and increase consistency across sites and participants.
The samples should not be stored in the –70ºC freezer until the subject is determined to be eligible. While eligibility is being determined, the pooled samples should be stored either in the ice bucket or in a standard –20º C freezer. Tubes may be frozen for 1 to 2 days in a –20 degree freezer before storage in a –70ºC freezer as long as the former does not have an auto defrost cycle. Samples from ineligible enrollees will not be stored, but will be discarded following the Enrollment Site's standard procedure for waste. Any tubes that were thawed and not used by the end of clinic hours are discarded and not re-frozen or kept for the next day.
II.2.4.4. Establish Eligibility, Form 04 (Randomization/Exclusion).
The Study Coordinator should now have the information needed to determine whether the subject is eligible for randomization, and does so by completing Parts A, B, C, and D of Form 04 (Randomization/Exclusion); shown on the next page.
To complete Form 04, begin by attaching a Patient ID (PID) label to the indicated place in the upper right-hand corner of page 1 of the form and by filling in the other identification information in the upper right-hand corner.
• To complete Part A of Form 04, the Site Coordinator should ensure that Form 10 (Baseline Obstetrical Data) and Form 11 (Periodontal Measurements) have been completed.
• If the subject's gestational age was uncertain or unknown at the time she was enrolled, the ultrasound scan should have clarified her gestational age. The exception is the Kentucky site, for subjects who do not receive their ultrasound until 18 weeks.

• If gestational age was left blank on Form 10, it should now be entered (Item A. 2 of Form 10). For the Kentucky site, if the woman has not had an ultrasound, place X’s in the dates for Item 4, “Date of Ultrasound.” Do not leave this field blank. Once the woman has an ultrasound, the Study Coordinator should make an error correction to replace the missing ultrasound date with the actual date.


• If a gestational age was entered on Form 10 but the ultrasound scan has resulted in a new estimate of gestational age at enrollment (or, for Kentucky, at the time of the later ultrasound), the Study Coordinator should make an error correction to replace the incorrect gestational age with the new, corrected gestational age. For more information on error corrections, see Section III.15, "Data Management and Error Correction".


• To complete Part B of Form 04, the Study Coordinator takes information from the Consent Form, Form 01 (Enrollment), Form 10 (Baseline Obstetrical Data) and Form 11 (Periodontal Measurements).


• For example, Item B. 1 asks whether the subject or guardian has signed the consent form; this is determined by checking the Consent Form, as indicated at Item B. 1.
• Item B. 2 asks whether the subject is at least 16 years of age; this is determined by checking the date of birth on Form 01 (Enrollment, Item 2).
• Item B. 6 requires computation of the percent of the subject's sites that bled on probing. This should be recorded to one decimal place, as provided on the form. The rule for rounding off the first decimal place is as follows. If the second decimal place is 4 or lower, simply drop the second and subsequent decimal places. If the second decimal place is 5 or higher, round the first decimal place up to the next highest number. Calculators follow this rule, so the correct rounding can be obtained by setting the calculator to show a single decimal place and recording the result. If the rounded percent of sites is 50.0% or higher, then Item B. 6 should be answered "Yes".
• To complete Part C of Form 04, the Study Coordinator takes information from Form 10 (Baseline Obstetrical Data) and Form 11 (Periodontal Measurements), as indicated.
• Item C. 1 asks if the subject cannot comply with the study protocol. The Study Coordinator should answer this based on the judgment of the clinicians who have seen the subject and on her/his own judgment about the subject's understanding of the study and ability to meet her responsibilities. If there is doubt about either the subject's understanding of the study or her willingness or ability to comply with study procedures, the Study Coordinator should answer "Yes" for this item, which will render the subject ineligible. The rationale for this cautious approach is that high attrition rates hinder the scientific integrity of the study.
• Item C. 3 should be completed by referring to the analogous items on Form 10 (Baseline Obstetrical Data, Item A.3) and Form 11 (Periodontal Measurements, Item b). If either of these forms records a "Yes" answer to the question "May the patient be placed at medical risk by participating?", Item C. 3 should be answered "Yes".
If the subject fails to meet any eligibility criterion in Part B or Part C, she cannot be randomized. There are no exemptions to the eligibility criteria.
• If the subject fails to meet any eligibility criterion, fill out part D of Form 04 recording that the subject is ineligible. For this subject, the enrollment process is over and Form 04 is complete. Dispense her gift certificate (described in more detail in Section III.12, "Incentive Payments (Gift Certificates)"), and thank her for participating. Dispose of her plaque sample properly, according to the Enrollment Site's standard procedure for biological waste.
• On this subject's line in the Patient Log (Form 03), record that she was not randomized using the check box on the extreme right of her line in the log.
• Make a copy of the original Form 04 and put the completed Form 04 in the next shipment of forms to the DCC.
• If the subject meets all the eligibility criteria in Parts B and C, fill out part D recording that the subject is eligible and send her to the lab for her blood draw (section II.2.4.5, "Blood Draw for the Serum Sample", below). Freeze the subject's plaque sample as described in Section III.2. "Collecting and Storing Dental Plaque Samples (Enrollment Site Procedures)".
• On this subject's line in the Patient Log (Form 03), mark that she was randomized, using the check box on the extreme right of the subject's line.
II.2.4.5 Randomize the Subject, Form 04 (Randomization/Exclusion), continued.
If Form 04 has been completed through Part D, the Study Coordinator's determination that the subject is eligible, then randomization is simple and is easily completed while the subject is at the lab having blood drawn.
When Form 04 has been completed through Part D, the Study Coordinator calls the registrar at the DCC, usually the Data Entry/Quality Control Operator, using the toll-free number (800) 353-8636. Such calls will be answered between 8:00 AM and 4:00 PM Central time, Monday through Friday, except for holidays at the University of Minnesota. The Statistical Study Manager will give Study Coordinators these holidays as far in advance as possible each year.
With the Study Coordinator on the phone, the registrar uses an interactive randomization program to review with the Study Coordinator the eligibility criteria in Parts B and C of Form 04. If all eligibility checks are satisfied, the registrar issues a treatment assignment to the Study Coordinator.
After receiving the treatment assignment, the Study Coordinator repeats the treatment assignment back to the registrar for verification. When the treatment assignment is verified, the Study Coordinator records the subject's treatment assignment in Part E of the subject's Form 04 by checking the appropriate box and signs the form. This completes Form 04 for this subject; this form should be copied and the original should be sent to the DCC in the next weekly shipment of forms.
The Study Coordinator also records on the Patient Log (Form 03) that this subject was randomized, by checking the appropriate box at the far right-hand end of the subject's line in the Log. Finally, the Study Coordinator records the registrar's initials in the Subject Log. This completes the randomization phone call.
(To further ensure that subjects receive the correct study treatment, once each week the DCC will call the Site to verify the treatment assignment of the most recently randomized subjects. Specifically, either the Statistical Study Manager or the Data Entry/Quality Control Operator will call the Study Coordinator and read over the phone the PIDs that have been randomized since the last such call and their study assignments. At the anticipated enrollment rate there should be no more than five to 10 new randomizations per site per week.
The randomization process can be stopped at any time if it becomes clear that the subject is not eligible. If this happens, change the response to part D of Form 04 recording that the subject is ineligible. For this subject, the enrollment process is over and Form 04 is now complete. Dispense her gift certificate (described in more detail in Section III.12, "Incentive Payments (Gift Certificates)"), and thank her for participating. Dispose of her plaque sample properly, according to the Enrollment Site's standard procedure for waste.
• On this subject's line in the Patient Log (Form 03), record that she was not randomized using the check box on the extreme right of her line in the log.
• Put the completed Form 04 in the next shipment of forms to the DCC.

II.2.4.6. Obtain Baseline Medications (Form 12, Medications). Having established the subject's eligibility, the Study Coordinator now records her baseline medications on Form 12. Parts A, B, and C of Form 12 provide check-boxes for the most common drugs in three classes of special interest in this study: anti-inflammatories, oral antibiotics, and vaginitis treatments. Part D provides space for recording other medications, including vitamins and dietary supplements. Record all medications used in the last six months.
T
o complete Form 12, begin by attaching a Patient ID (PID) label to the indicated place in the upper right-hand corner of all three pages, and by completing the other items in the upper right-hand corner of page 1.
Part A asks about anti-inflammatory medications, in particular non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids.
• For each drug listed by name (Tylenol, Motrin, ibuprofen, prednisone, and betamethasone), indicate whether the subject has or has not used the drug in the last six months by checking Yes or No respectively on the line for that drug. Drug names can be generic or proprietary as long as the correct name/spelling of the drug is recorded. If the subject has used the drug, record the dose and frequency of usage for that drug in the space provided. Record the dose in the two boxes under “Daily Dose.” To record the units of the dose, enter into the box under "Unit" the appropriate code given on Form 12 just under the instructions. The codes are: 1 = tablets, 2 = capsules, 3 = mg, 4 = mcg, 5 = puffs, 6 = ml, 7 = drops,

8 = grams, 9 = teaspoons, 10 = tablespoons and 11 = other. Code 11 should be used rarely if at all; if it is, the other unit of measurement should be recorded in the table just under the instructions. Similarly, record the frequency of the dose by entering in the box under "Freq" the appropriate code given on Form 12 just under the instructions. The codes are: 1 = QD (once a day), 2 = BID (twice a day), 3 = TID (three times a day), 4 = QID (four times a day), and 5 = PRN (as needed).


Then record the dates the drug was started or stopped. If the drug is still being taken, put "X" in each box provided for the stopping date. If the subject is unsure about the dates, try to get at least the month correct, and enter "X" in the day boxes to indicate that the data are simply not forthcoming.

Other NSAIDS are recorded in Item A.1.d; other corticosteriods are recorded in Item A.2.c; and other anti-inflammatories are recorded in Item A.3. In each case, all items are completed as above, except that the medication's name must be PRINTED IN BLOCK LETTERS in the slot provided. To reduce the frequency of spelling errors, see the instructions given for Part D, below. If no "other" drugs were used by the subject, check "No" to indicate that they were not used.



Parts B and C are completed just like Part A, except now the drugs are oral antibiotics and vaginitis treatments, respectively. In particular, each listed drug and "other" should be checked Yes or No to indicate (respectively) that they were or were not taken by the subject. Other oral antibiotics are indicated using Item B.8; other vaginitis treatments are indicted using Item C.5. These Items are completed like Items B 1 to 7 and C 1 to 4, except that the drug's name is PRINTED IN BLOCK LETTERS in the space provided. To reduce the frequency of spelling errors, see the instructions given for Part D, immediately below.
• Part D records other drugs, vitamins, or supplements the subject has taken in the last six months. Start a fresh line in Part D for each other drug.
If the subject took any vitamins, including multivitamins or individual vitamins, PRINT IN BLOCK LETTERS "vitamins" as the "Medication" (the left-most column of Part D), record the frequency in the "Freq" column, and record the starting and stopping dates as usual.
If the subject took any other dietary supplements, PRINT IN BLOCK LETTERS "supplements" as the "Medication" (the left-most column of Part D), record the frequency in the "Freq" column, and record the starting and stopping dates as usual.
If the subject took any other drugs, that is prescription or over-the-counter drugs other than anti-inflammatories (Part A), oral antibiotics (Part B), or vaginitis treatments (Part D), PRINT IN BLOCK LETTERS the drug's name (generic or proprietary) in the blank under "Medication" and complete the rest of the line as previously described.
• To reduce errors in writing drug names, the Data Coordinating Center (DCC) will provide each Site a list of drug names, with each drug described according to its drug class, for example "Abbokinase: Thrombolytic". To record an "other" drug in any Part of Form 12, the Study Coordinator should locate the drug's name first in the DCC's list and spell it exactly that way on Form 12. Then when the Data Entry/Quality Control Operator keys in the drug name, it can be identified automatically by the DCC's database, using the same list of drug names.
Of course, sometimes a drug's name will not be on the DCC's list. In these cases, the Study Coordinator should PRINT IN BLOCK LETTERS the drug's name in the usual spot, then send an e-mail to the DCC's Statistical Study Manager to warn that a new drug name is coming. This e-mail should include the subject's PID and visit number, the date of the form, the drug name as written on the form, and the class of drug.
II.2.4.7. Blood Draw for the Serum Sample.
For Sites other than Lexington (University of Kentucky), the Study Coordinator escorts the subject to the Enrollment Site's clinical lab carrying the order for a blood draw. Specifically, in addition to any lab orders the Site may make as part of its standard of care, the coordinator and subject go to the lab with the special request form specific to the Site (details are given below). The coordinator also takes five screw-top plastic tubes provided by the Host Response Lab. The tubes are prepared with pre-printed labels indicating the subject's PID and visit. Finally, she takes a set of five more labels used for labeling the tube(s) into which the blood is drawn and in case serum-tube labels are damaged. To ensure that the subject's confidentiality is protected, the subject's name only, not her PID, is written on the special request form. To ensure that the labels are not separated from the special request form, the Study Coordinator puts both the special request form and the labels into a transparent zip-loc bag before taking them to the clinical lab.
For the Lexington (University of Kentucky) Site, the subject's blood is drawn in the Ob-Gyn clinic and taken directly to the Host Response Lab for serum extraction and storage.
Details of the serum sampling procedure for each Site, including the specific wording of special request forms, are given in Section III.4.2. "Collecting, Processing, and Storing [Serum] Samples".
It is extremely important that a randomized subject have blood drawn, return to make appointments for Essential Dental Care and study therapy, and receive her gift certificate. Study Coordinators should use appropriate methods to ensure that these things happen, for example, by sending an escort to the lab with the subject or providing the subject with a detailed map of the Site.
II.2.4.8. Schedule appointments for Essential Dental Care and, if appropriate, for study periodontal therapy
Appointments are made so that Essential Dental Care and study periodontal therapy are completed before the 20th week of pregnancy, preferably before Study Visit 2. Try to schedule them to occur as soon as possible after the Baseline/Randomization Visit (Visit 1) to allow for cancelled or missed appointments.
If the subject has a regular dentist, the Study Coordinator has recorded that dentist's name and address on Form 03 (Subject Locator Information). The Study Coordinator now mails a letter to the subject's regular dentist informing her/him of their patient's participation in the trial. The letter briefly explains the study and requests that all periodontal or dental hygiene treatment be done within the study.
Subjects are free to seek dental care outside of the study, but the study will not pay for it. At this point in the visit, the Study Coordinator reminds the subject not to receive periodontal or dental hygiene care from her regular dentist during her pregnancy, and tells the subject that if she receives care from a dentist outside the study, she will receive no more dental care from the study, though she will still be followed for delivery data. When the subject finishes her participation in the study, she will be told of any need for additional dental care and will be given a list of clinics where follow-up is available if she does not have a regular dentist.
Despite the best efforts of study personnel, some subjects may not complete Essential Dental Care and study periodontal therapy before Visit 2. This will be considered a protocol violation. Subjects should complete their essential dental care (and test subjects, their periodontal care) as soon after 20 weeks gestation as possible, provided the subject is not at medical risk for continuing with this care. All care after 20 weeks gestation should be approved by the primary OB before any care is initiated.
II.2.4.9. Dispense the Gift Certificate.
At the end of this visit, the Study Coordinator should give the enrolled subject a gift certificate for $20 as the incentive payment for the visit. The subject will also receive a small gift for her newborn. Procedures for managing and accounting for the gift certificates are described in Section III.12. "Incentive Payments (Gift Certificates)".
II.2.4.10. Begin the Event Checklist (Form 05).
The purpose of the Event Checklist (Form 05) is to help the Study Coordinator keep track of data or samples that need to be collected at each visit. It should be especially helpful for subjects who miss visits at which data or a sample is collected, because in those cases the data or sample should be collected at the next scheduled visit. This issue is discussed further below, in Section II.5, "Maintenance Visits (Visits 2 to 6)".

II.3. Essential Dental Care
II.3.1. Timing of Essential Dental Care.
After the Baseline/Randomization Visit (Visit #1), subjects will be referred to the Enrollment Site's General Dentist as needed for essential dental care.
II.3.2. Definition of Essential Dental Care

Essential Dental Care is defined as an examination for diagnosis and treatment planning, and treatment for abscessed teeth and dental caries. We estimate that each subject will need one dental visit for examination and diagnosis and two dental visits on average to complete their Essential Dental Care, for 3 visits total on average. Essential Dental Care should be completed before the 20th week of pregnancy, preferably before Visit 2, approximately 4 weeks after the Baseline/Randomization visit.
In the event the a woman refuses Essential Dental Care following randomization, the woman should continue to be followed and treated based on her group assignment. During the informed consent process, it should be made clear that women are expected to have their essential dental needs addressed. Women who at the time of the informed consent process state they are not interested in undergoing this treatment should not be randomized and should be excluded from the study.
No dental radiographs will be taken at the Baseline Oral Exam (section II.2.4.1) or as part of the study protocol, but during Essential Dental Care radiographs may be taken as indicated for diagnostic purposes, as determined by the General Dentist.
The Enrollment Site's General Dentist will make all treatment decisions for referred subjects. Treatment is likely to include placement of temporary and/or permanent composite or alloy restorations, tooth extractions, and endodontic therapy. No fixed or permanent removable prosthesis or permanent crowns will be fabricated as part of the study, though temporary removable partial dentures will be fabricated for esthetic or functional purposes to replace teeth extracted during the study. No cosmetic procedures will be provided as part of essential dental care.

For subjects who have a personal dentist outside of the study, a brief summary of completed essential dental care will be sent to her dentist following her delivery.



II.3.3. Documenting Essential Dental Care: Form 20 (Confirmation of Essential Dental Care).
Essential Dental Care is documented on Form 20 (Confirmation of Essential Dental Care).



Form 20 should be completed by the General Dentist who provides the Essential Dental Care.


The Patient ID (PID) number should be written in the upper right-hand corner of the form, or a PID label should be attached in that location if a label is available. The "Clinical Unit" should be filled in as "NY" for New York, "MN" for Minneapolis, "KY" for Lexington, Kentucky, and "MS" for Jackson, Mississippi.
• If the subject finished all of the Essential Dental Care planned for her by the General Dentist, Item 1 should be answered "Yes". Otherwise, Item 1 should be answered "No".
The other questions on this form are intended to describe when Essential Dental Care was provided and how extensive it was. Thus, Form 20 does not record all the detailed information contained in the dental chart, but only the number of visits (Item 2), the dates of the first and last visits (Item 3), and counts of teeth extracted, temporary fillings placed, permanent restorations placed, teeth receiving endodontic treatment, and whether a temporary denture was placed to replace teeth extracted as part of Essential Dental Care (Items 4 a, b, c, d, and e respectively).
In the event that the subject has her own dentist outside of the study, a summary of completed essential dental care will be forwarded to the subject’s regular dentist after the subject delivers her baby.
II.3.4. Incentive for Completing Essential Dental Care: A Gift Certificate for Each Visit
Subjects are given a gift certificate after each essential dental care visit as an incentive to attend the visit and receive the care.
For most Enrollment Sites, the Study Coordinator is responsible for the gift certificates and their distribution to subjects. This is practical at those sites because the dental clinic is located close enough to the Study Coordinator that s/he can dispense them after the last Essential Dental Care visit.
For subjects enrolled at the Minneapolis Enrollment Site, gift certificates for Essential Dental Care Visits are dispensed at the University of Minnesota Dental School and Clinics by the General Dentist who delivers the Essential Dental Care.
Procedures for managing and accounting for the gift certificates are described in Section III.12. "Incentive Payments (Gift Certificates)".
II.4. Study Intervention: Immediate Periodontal Therapy (Test Group)
II.4.1. Specification of the Study Intervention
Objective: The objective of this treatment is to eliminate as much periodontal infection and gingival inflammation as possible using mechanical non-surgical scaling and root planing, mechanical debridement, improved oral hygiene, and monthly tooth polishings and oral hygiene reinforcement.
Overview: Test subjects will be scheduled for a 1.5-hour appointment for full-mouth supragingival and subgingival scaling and root planing and oral hygiene instruction. If needed, additional 1.5-hour appointments will be scheduled within 14 days. Test treatment must be completed in four or fewer sessions. Topical or local anesthetics will be used as needed for subject comfort.
Specific Methods: Each patient will receive supra- and subgingival scaling and root planing using a combination of hand and ultrasonic instruments. All detectable non-mineralized and mineralized tooth and root accretions will be removed and the tooth roots clinically smoothed. A #11-12 Hu-Friedy® explorer will be used to detect calculus.
Curets and scalers may be used for hand instrumentation. Ultrasonic instrumentation will be accomplished using a Dentsply Cavitron SPS unit or similar ultrasonic instrument. Ultrasonic handpiece inserts will include Dentsply FSI slimline inserts or other similar instruments as appropriate.
Local anesthesia, using topical anesthetics, infiltration or regional nerve blocks, will be used as needed for patient comfort. The minimum dose required for adequate anesthesia should be used. Allowable topical anesthetics are 5% lidocaine, 20% benzocaine and 1% dyclonine HCL. Preferred injectable anesthetics include 2% lidocaine (e.g., Xylocaine) with 1:100,000 epinephrine; 4% prilocaine (Citanest) with 1: 200,000 epinephrine; or 4% prilocaine without a vasoconstrictor. The Food and Drug Administration (FDA) considers lidocaine and prilocaine as category B, i.e., relatively safe drugs for use in pregnant women.
The therapist must be knowledgeable about the maximum allowable dose for any local anesthetics used based on the subject’s weight, age and medical status. Other topical or injectable anesthetics may be used provided they are used judiciously and are safe for use in pregnant women.
Supragingival or subgingival irrigation with antimicrobial agents (e.g., chlorhexidine) is not allowed. Use of local or systemic antibiotics, especially the tetracyclines, is also not allowed. (Recall that women who require antibiotic premedication prior to periodontal scaling are excluded from participating.)

Acetaminophen (up to 625 mg) may be administered for immediate post-operative discomfort as needed. No other analgesic agents should be used without prior consultation with the subject's obstetrician.


Oral Hygiene Instruction. Test subjects will be instructed in the modified Bass sulcular method of tooth brushing using a soft Oral B 35-indicator straight toothbrush. The therapist or assistant will review cleaning facial and lingual surfaces of both anterior and posterior teeth. After receiving these instructions, the subject should be asked to demonstrate use of the brush in her own mouth.
Subjects will also be instructed in using dental floss. Subjects should be shown how to clean 1-2 mm subgingivally on proximal tooth surfaces and should demonstrate use of the floss in their own mouths. Subjects will be given waxed dental floss and instructed to floss once per day in the evening. Unwaxed floss, dental tape, yarn, mechanical flossing aids, or other mechanical interdental cleaning devices may be used if, in the therapist’s opinion, use of these products will facilitate daily cleaning.
II.4.2 Timing of the Intervention

All periodontal treatment will be completed between the beginning of the 13th week and the end of the 20th week of gestation. It may be the case that a woman who is enrolled at 13 weeks (Visit 1) and thus attend Visit 2 at 17 weeks (1-month after baseline) may not have her periodontal treatment completed until week 19. While this is still within the appropriate time window (before 20 weeks), the woman’s second visit could precede the completion of periodontal treatment. Thus, if she is in the test group, she could be scheduled for a polish and examination before she completes periodontal treatment. In most instances, the periodontal treatment will be completed before Visit 2. However, in cases where periodontal treatment is not completed before Visit 2, both Visit 2 and the periodontal treatment should be completed during Visit 2.


II.4.3. Who Provides the Intervention?
The Periodontal Hygienist, under the supervision of the Enrollment Site's Periodontal Investigator (PI), will provide the test periodontal treatment.
The Enrollment Site PI will monitor the Periodontal Hygienist to ensure that all treatments are performed according to the study protocol, as specified in this document.
II.4.4. Documenting the Intervention (Form 21)
Study periodontal treatment is documented on Form 21 "Confirmation of Study Periodontal Therapy", which records the time required for treatment, topical anesthetics used, and local anesthetics used. The form presumes that at most four sessions are used to deliver the study periodontal treatment.
T
o complete Form 21, begin by attaching a Patient ID (PID) label to the indicated place in the upper right-hand corner of page 1 of the form and by filling in the other identification information in the upper right-hand corner.
• Item 1 records the dates and times of sessions in which study periodontal therapy was delivered. Record the time that debridement began and ended, using a 24-hour clock for times.
If only one session of debridement was needed, indicate this by placing "X" in each of the seven boxes recording the date of the second, third and fourth sessions.
• Items 2 and 3 are self-explanatory. If only one session of debridement was necessary, leave blank the items referring to the non-existent sessions of debridement.

II.4.5. Incentive for Completing Study Therapy: A Gift Certificate for Each Visit
Subjects are given a gift certificate after each study therapy visit as an incentive to attend the visit and receive the care. Subjects are also given a small infant gift.
The Study Coordinator is responsible for the gift certificates and their distribution to subjects. Procedures for managing and accounting for the gift certificates are described in Section III.12. "Incentive Payments (Gift Certificates)".

II.5. Maintenance Visits (Visits 2 to 6)
II.5.1. Objectives
For subjects in both study groups, the maintenance visits have these objectives:
• to monitor for adverse events and

• to collect medication data (Form 12).


For the Test Group (immediate periodontal therapy), the maintenance visits have these additional objectives:
• to provide professional plaque control at monthly intervals

• to reinforce daily oral hygiene



• to remove any residual or recurrent calculus deposits
For the Control Group (deferred periodontal therapy), the maintenance visits have this objective in addition to the common objectives: to provide "attention placebo” visits so that test and control subjects are seen for the same number of study visits.
Note that the baseline and subsequent periodontal data are available at the maintenance visits. This allows the examiner to compute changes in attachment loss since baseline, to assess disease progression, and to take plaque samples from the same sites that were sampled at baseline.

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