Chapter 9 Postpartum Periodontal Data collection



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CHAPTER 9

Postpartum Periodontal Data collection



9.1. Purpose

The purpose of the Postpartum Periodontal Visit is to make an end-of-study full-mouth periodontal assessment of each study participant and to collect plaque from the same sites sampled at baseline.

The examination follows the same procedures as the baseline examination, including screening for oral lesions, and collection of relevant periodontal data including tooth status identification (i.e., missing, implant, etc.), plaque and gingival indices, probing depths, CEJ levels and bleeding upon probing measures. The participant will also be queried regarding any non-study dental procedures they had during their pregnancy.
9.2. Timing / Scheduling of the Postpartum Periodontal Visit

The Postpartum Periodontal visit occurs after delivery, preferably while the participant is still hospitalized. The examination can be done either chair-side or bedside. The examination should be scheduled as soon as possible after the delivery, in order to assure that the examination is done prior to the participant’s discharge.

This visit requires approximately one hour. The visit examination and data collection are performed by a study-calibrated Periodontal Examiner, preferably the same examiner who conducted the baseline examination.

9.3 Staffing


Staff involved with the collection of MOTOR postpartum periodontal data and specimens must have completed appropriate training and certification procedures (see Chapter 2). In addition, for blinding purposes, postpartum examination should not be performed by those who functioned as therapists providing prenatal periodontal treatment, or who were part of the randomization procedure of participants. Examiners should not become un-blinded to treatment assignment prior to the postpartum examination.

In addition to the Examiner, another individual should be familiar with the MOTOR Dental Data Entry System (DDES) to act as a recorder during the examinations. The DDES is an interactive program contained on a study laptop for entry of all periodontal scores and measures obtained during the examination.



    1. Procedures and Forms


The following procedures and data collection forms are required at the Postpartum Periodontal:

  • Postpartum Examination

    • Vital Signs

    • Medical and Medication History

    • Oral Exam

    • Periodontal Examination

    • Periodontal Postpartum Examination Form (DPE)

    • Specimen Collection Packet #6

    • Plaque Specimen Collection

Dental Data Entry System (DDES) or Emergency DDES Form

Note: Prior to the participant visit, the examiner must review the participants Baseline Periodontal Examination Form (DBE) or run the Plaque report on the WEB DMS to have the sites identified that are needed for plaque specimen collection.
Note: Specimens are to be collected only on participants who have given consent for collection.


9.5. Postpartum Dental Examination


Since this examination occurs post delivery, while the participant is still in the hospital, the examination may take place in the hospital bed. The basic procedures for the postpartum examination are the same as the baseline examination. The exceptions are:

  • Postpartum visit number = 04

  • Post Partum Examination Form, see Section 9.5.1 below

  • Plaque Specimen kit #6 is used post partum

  • Plaque samples are collected from the same sites as identified during baseline, see Section 9.6 below.

  • Calculus Index, see section 9.5.1 below.

Refer to Chapter 5, Sections 5.6 for specific details on the required procedures and measures for the periodontal exam.
9.5.1. Subgingival Calculus

At the end of the post-partum exam, following plaque specimen collection, the examiner should determine the absence or presence of subgingival calculus at all sites with a pocket depth of 5mm or greater. If the examiner is using the DDES, the system will automatically identify the sites and require a code to be entered. If however, paper forms are being used to record periodontal data it will be up to the examiner to review the paper forms to identify all sites measured 5mm or greater and record the calculus code for each site on the appropriate page. These codes will be entered into the DDES when the forms are entered.


Once the sites have been determined the examiner will assess the presence or absence of subgingival calculus using a universal explorer; like the ODU 11/12 and exploratory strokes. However, if the site does not have a universal explorer available then the examiner should use both an anterior explorer (similar to the HU 17) and posterior explorer (pigtail type) appropriately with exploratory strokes. The calculus codes include the following:

0= absence of subgingival calculus

1= presence of subgingival calculus

9.5.2. Periodontal Postpartum Exam Form (DPE)


T

he Periodontal Postpartum Exam Form (DPE) documents procedures taking place during the postpartum exam, including the results of the current medical and medication history, the results of the oral examination, and the collection of plaque samples taken during the periodontal examination described below. Refer to the DBE QXQ’s for specific instructions on completing this data collection form.

9.6. Plaque Specimen Collection


General procedures for plaque collection are covered in Chapter 5, Section 5.6.7.

Specimens are to be collected from the same sites identified during the baseline examination. Refer to the baseline DBE form in the participants study chart, or run the ‘Plaque Site Report’ under Reports on the Web based DMS (note this program must be run remotely on the WEB DMS, and cannot be accessed using the local system).


Exception: If on the post-partum visit a tooth is missing that had previously been identified as a plaque sample site, then the sample will not be taken for that quadrant.

After the plaque samples have been collected, they can be stored at room temperature, placed on dry ice or placed in the provided ultraflow freezer. Prior to shipment to UNC plaque samples should be frozen for at least 24 hours.



9.6.1. Plaque Specimen Collection Packet #6


Samples are collected using Collection Packet #6, containing pre-labeled bar-coded, plaque sample collection kits and vials (numbered 201-204) with clear or white caps, provided to each center. Collection tubes are to be prepared with sterile TE buffer (supplied by UNC), after specimen collection NaOH is aliquoted into each tube The collection packet also contains extra pre-coded labels ending in ‘000’; one of these is the ‘paperwork’ label to be affixed onto the DPE form in the space provided. This provides the data link between the sample ID number and the participant ID number.

9.7. Scheduling Treatment for Delayed Treatment Participants


Scheduling of treatment for the delayed treatment group should be made after all postpartum examinations and data collections are completed.

Chapter 9: Postpartum Periodontal Data Collection 9/12/2006 Page 9 -


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