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



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Inclusion/ Exclusion

You will be asked to be in this study if:

1. you are pregnant

2. you are 16 years of age or older

3. you have no medical condition that would require you to take antibiotics before

dental treatment

4. you have 20 natural teeth

5. you have enough gum disease to qualify for the study


You will be excluded from this study if you:

1. you are under age 16

2. are unable to give informed consent

3. are unable to cooperate with the study procedures

4. might be placed at known medial risk as a result of participation

5. have mitral valve prolapse, a history or rheumatic heart disease with regurgitation,

joint replacement or other medical conditions that requires you to take antibiotics

before dental treatment, or

6. are going to give birth to more than one baby as determined by ultrasound

Withdrawal from the Study:


  1. You may withdraw from the study at any time for any reason. There is no penalty to you for withdrawing.




  1. You may be asked to withdraw from the study for the following reasons:

  1. you miss three of your scheduled appointments

  2. your obstetrician determines it would be unsafe for you or your baby to continue

  3. our examinations show that your periodontal disease is spreading rapidly and you need more advanced care

  4. you receive dental care from a dentist other than a research dentist without first asking the research doctors.

If you withdraw from the study or you are asked to withdraw by the study doctors, you will not have any needed dental work provided or paid for by the study.



Duration of the Study:
You will be enrolled in the study during your second trimester and remain in the study until after your baby is born. The entire study itself will run for three years.
Your rights:
This consent form gives you information about the study that will be discussed with you. After we talk to you about the study, you will be given this form to take home. If you decide to volunteer after reading and thinking about this information, you will be asked to sign this consent form. You will be given a copy of this to keep.
It is important for you to know:

  • your participation is strictly voluntary

  • you may decide not to participate in the study or to withdraw from the study at any time without penalty or loss of benefits or treatment to which you are entitled

  • you will be told about any changes to the study and may be asked to sign a new consent form.

  • if early results show that there is a relationship between periodontal disease and negative birth outcomes, you will be told and will be offered the appropriate treatment

  • you have the right to ask questions concerning the potential or known hazards of this study at any time. If you have any questions regarding your rights as a volunteer subject or about the study, contact Dr. Stephen Matseone, department of Obstetrics and Gynecology, Harlem Hospital Center, at (212) 939-4335. You may also contact Dr. Dennis A Mitchell, at the Division of Periodontics, Columbia University School of Dental and Oral Surgery, at (212) 305-9289.


You may discuss your rights as a research subject with the Institutional Review Board of Harlem Hospital Center, at (212) 939-4160.

Cost to You:
There is no cost to you for participating. Participation in this study does not change your payment obligations for your prenatal obstetrics visits or delivery charges, if you have some.


Compensation


You will not receive any reduced prenatal fees or any credits toward care by volunteering for this study. Due to your willingness to participate, however, all the dental treatment you receive from the research clinic will be free of charge. In addition, you will receive a gift certificate from Target Stores worth $20 each time you come in for an appointment after enrollment. You will not receive a gift certificate for missed or cancelled appointments. Every effort will be made to schedule your dental exam appointment on the same day as your prenatal visit so you will not have the expense of extra trips to the clinic.

Potential Risks:

Pregnant women can receive routine dental care without harm to themselves or their baby. However, routine dental exams and treatment can cause bacteremia which means germs that are normally in your mouth get into your bloodstream, something which happens whenever you routinely brush your teeth, too. There is no information to say that this will cause harm to your baby or you. In order to reduce the risks of preterm delivery, maternal infection, premature rupture of membranes, spontaneous abortion or other unknown adverse events, all gum treatment and dental care for this study will be done after the first trimester when the formation of your baby is complete and after the time when most spontaneous miscarriages occur.


Some studies have shown that treating certain vaginal infections with antibiotics during pregnancy can lead to premature birth. No antibiotics will be used in this study. No studies have ever shown that treating periodontal disease leads to premature birth.
Pregnancy may cause your gums to become swollen and sore but the bone that holds your teeth in is generally not harmed by pregnancy. Gum disease progresses very slowly over many years in most people who do not have other health problems. If a person has gum disease, it generally does not get worse over a nine-month period to the point where teeth are lost. If your monthly examination confirms that your gum disease is getting worse, you will be withdrawn from the study and you will be treated.
Some people find having their gums and teeth examined and cleaned is uncomfortable. A small amount of local anesthesia is safe during pregnancy and may be helpful to make you more comfortable. If you do not want to continue or choose not to have local anesthesia, then you may withdraw from the study with no penalty. If the soreness bothers you so that you cannot eat, you can call Dr. Dennis Mitchell, at Columbia University-Harlem Hospital Center (212) 304-7171.
During the third trimester, reclining in a dental chair may be uncomfortable. Every effort will be made to assure your comfort. The dental chair can be adjusted.

Potential Benefits:
According to the National Institutes of Health and the Surgeon General's Report on Oral Health, over 90% of Americans have gum disease. By participating in this study, you will learn if you have gum disease. One half of the women in the study will have their disease treated before the baby is born and the other half will have it treated after the baby is born. Finding and treating gum disease at an early age helps prevent tooth loss as you get older.
Everyone who has cavities will have them treated. If a tooth needs to be extracted or needs a root canal to save it, that will also be done. If you lose a tooth during the study that causes space in the front of your mouth or changes your bite so you cannot chew, a temporary partial denture will be made for you. No permanent bridgework or caps will be done. No cosmetic dentistry will be done.
It is possible that treatment of your gum disease will reduce your chances of having a premature baby or other adverse event.

Compensation For Injury:
If you are injured as a result of being in this study, the Harlem Hospital Center will treat you at no cost to you if you need immediate attention. If additional treatment for injuries is required, you will be informed where to obtain such assistance. Neither the sponsor The National Institute of Dental and Craniofacial Research, nor Harlem Hospital pays for additional treatment of injuries someone might suffer during a clinical trial. Thus, you (your insurer, Medicare or Medicaid) would have to pay for such treatment of an injury suffered during the trial. If you believe you have been harmed, please contact the Institutional Review Board at the Harlem Hospital Center, (212)939-4160 for information on your rights on how to proceed.

Confidentiality:
No one except the people working on this study will know that you are in the study. The people who will see your records include the doctors and workers at the clinic or hospital who are working on the study. Also, members of the Harlem Hospital Center’s Institutional Review Board or other officials as requested by state or federal law may see your records for purposes of reviewing the study material only. You will be identified by a code number and personal information about you will not be released without your written permission. You will not be personally identified in any published reports of this study.
I have also been told that the researchers have obtained a Certificate of Confidentiality. This certificate protects the investigators from having to release the names or other identifying characteristics of research subjects. Investigators so authorized may not be compelled in any Federal, State, or local civil criminal administrative, legislative, or other proceeding to provide identifying information about research participants even if subpoenaed.
Representatives of the Food and Drug Administration (FDA), the Office for Human Research Protections and/or other regulatory agencies or members of the Study Data Safety and Monitoring Board may inspect your records. They will maintain confidentiality.

Other Dental Visits During the Study:
If you choose to see your own dentist for dental work during the course of the study, you may do so. However, you will not be reimbursed for those visits and you will have to pay for them yourself. As a condition of staying in the study, you will be asked not a have your teeth cleaned or to have any periodontal treatment other than what is being done for you in the study by the study doctors and dental hygienists. If you have cleanings or periodontal treatment outside the research clinic, you will be asked to leave the study and no further treatment will be provided or paid for by the study. If you have any questions or concerns about the care you receive, an outside independent dentist is available for consultation.

I have carefully reviewed the contents of this form. I have had the opportunity to ask my doctor questions about this study and my participation in it. Before giving my consent by signing this form, I have been sufficiently informed of the reason, means and duration of this study; and the reasonably foreseeable inconveniences, hazards or adverse effects that may result from my participation. By signing this form, I have not waived any of the legal rights that I would otherwise have.


I understand the importance and potential value to me and others of taking part in this investigation. I understand there are risks, both known and unknown. The known risks have been explained to me. I understand there are unforeseeable risks to my baby and myself. I accept these risks and desire to participate.
I understand I am participating of my own free will and that I may discontinue whenever I choose. I understand that if I have any questions regarding this study or this form, they will be answered so that I satisfactorily and completely understand.
I acknowledge my responsibility to keep my appointments with my doctors and to report to them immediately any changes in my health or the earliest suggestion of something wrong. I understand I will be dropped from the study if I fail to keep my appointments.
I understand I may see my dentist for care during the study only after discussing it with the research doctors. I will be responsible for the cost of these visits. This dental care cannot include any periodontal treatment until after the baby is born. I understand I will be dropped from the study if I receive any cleanings or periodontal treatment from any one other than the research staff. I understand that if I withdraw from the study or if I am removed from the study by the investigators, the study will not provide or pay for any needed dental or periodontal care.
I understand that the dental treatment I receive is for improvement of my oral health. No cosmetic dental work will be provided.
I understand the study doctor will inform me if my periodontal disease begins to progress rapidly and that, if it does, I will receive the appropriate therapy or be referred to another doctor for treatment.
I authorize release of information from this study to those agencies designated by the Principal Investigator.
I, ________________________________ have read and do understand all the preceding information describing this study, and all my questions have been answered to my satisfaction. I voluntarily consent to participate in this study.
I understand that by signing this form I am not waiving any legal rights I may have.

________________________________ _________________________

Signature of the Patient Date

_________________________________ __________________________

Signature of Witness Date
I have explained to the volunteer the purpose of participation in this study, and have answered the volunteer's questions. To the best of my knowledge, she understands the purpose, procedures, risks and benefits of this study.
Person obtaining informed consent:________________________________________
Signature of person obtaining informed consent_______________________________

Signature of Investigator:______________________________Date_______________


Principal Investigator: Dr. Stephen Matseone

Director, Department of Obstetrics and Gynecology

Harlem Hospital Center

506 Lenox Avenue,

New York, N.Y. 10037

(212) 939-4335


This project has been approved for the recruitment of subjects by the Institutional Review Board of the Harlem Hospital.


Revised 3.26.03

III.6.3.1 Pre-Screen Consent forms for Minneapolis Enrollment Site

PATIENT INFORMED CONSENT – SCREENING EXAMINATION
We are conducting a study to determine if treatment of gum disease in pregnant women can reduce the risk of delivering babies who are either premature (born too soon) or very small. Gum disease is an infection caused by bacteria (germs) that can very slowly and painlessly destroy the bone around your teeth. Gum disease is usually treated by thoroughly cleaning the teeth above and below the gum.
Drs. Tony DiAngelis and Virginia Lupo of the Hennepin County Medical Center are conducting this study. Hennepin County Medical Center is one of four hospitals nationwide participating in this study.
Briefly, half of the women enrolled will receive free treatment for their gum disease during their second trimester of pregnancy. The other half will receive the same free treatment after they deliver their babies. The decision to treat a woman before or after she delivers will be randomly determined (say, by the flip of a coin) and a woman will not be able to choose when she receives this treatment. To be eligible for the study, however, a woman must have a certain amount of gum disease, which can only be determined through a dental examination. No drugs (other than local anesthetics if needed) or medical devices will be used as part of this study.
You are invited to receive a screening (brief) dental examination because your doctor has determined that you are between 13 and 16 weeks pregnant. If you appear to qualify for the study based on this brief exam, a researcher will discuss the full study with you in more detail and you will be asked to read and ask questions about another, more detailed Informed Consent form.
During this brief exam, a dentist or dental hygienist will ask you a few questions about your health and any medicines you take to make sure the exam is safe. This person will then examine your mouth using a dental probe with a dull tip that will be moved around your teeth to measure the space between your gums and teeth and to see if you have signs of gum disease. This is identical to what is done during a routine visit to the dentist or hygienist. No x-rays will be taken.
You can change your mind and decide not be continue with the screening exam at any time for any reason. You will not be treated differently if you decide not to complete this exam.
There is no cost to you for undergoing this brief exam, nor will you be paid. Agreeing to receive this brief exam does not change your payment obligations for your prenatal obstetrics visits or delivery charges, if you have some. In case of injury or illness resulting from your participation in this study, medical treatment is available to you at the Hennepin County Medical Center. You will be charged the usual and customary charges for any such treatment you receive.
Pregnant women can receive routine dental examinations and care without harm to themselves or their babies. However, routine dental exams and treatment can cause bacteremias, which means germs that are normally in your mouth get into your bloodstream. This also happens whenever you brush your teeth. It is very unlikely that any bacteremia you experience during or after this brief exam will harm you or your baby. You may experience some discomfort during the exam, especially if your gums are infected. You may also notice some bleeding, particularly if your gums bleed when you brush or floss your teeth. The risk of infection, however, is very small.
Agreeing to receive this brief exam does NOT mean that you are enrolled in the study. The purpose of this brief exam is to determine if you might qualify for the study. There is no guarantee that you will qualify for the study, even if you are told at this time that you might.
Other than learning about your oral health and whether you might qualify for the study, you will receive no direct benefit from receiving this brief exam.
The results of this exam will be kept confidential. If you do not qualify, or decide not to enroll in the full study, we will not keep a record of your name or other information that would enable anyone to know that you received this exam.
Your signature below indicates that you understand the information contained in this form, and that all of your questions have been answered to your satisfaction.

I voluntarily consent to receive a brief dental examination. .

__________________________________ ________________________

Signature of Participant Date

__________________________________ ________________________

Signature of Person Seeking Consent Date



III.6.3.2 Consent forms for Minneapolis Enrollment Site

Hennepin County Medical Center

Patient Informed Consent




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