CHAPTER 5 BASELINE PERIODONTAL VISIT

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1 CHAPTER 5 BASELINE PERIODONTAL VISIT 5.1. Purpose The purpose of the Baseline Periodontal Visit is to make a full-mouth periodontal assessment of each eligible subject and to collect baseline plaque samples. The examination will include screening for oral lesions and apparent dental disease, 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. In addition a short dental history questionnaire will be administered Timing / Scheduling of the Baseline Periodontal Visit The Baseline Periodontal visit occurs after a participant s study eligibility has been confirmed and the participant has been enrolled. While it is preferable for the Baseline Periodontal visit to occur during the same clinic visit as the Baseline Obstetric visit, the visits can also occur before or after each other, at different clinic visits. All baseline data collection is documented as visit = 02. The Baseline visit(s) should be scheduled as soon as possible after eligibility is determined. This periodontal visit requires approximately one hour. Both the Periodontal and Obstetric baseline visits must be completed before participant randomization. Randomization can occur at the same clinic visit as the baseline visit(s), after data collection procedures are completed. Randomization and all treatment visits must be completed prior to 23 6 weeks gestational age, so it is important to schedule baseline visits as soon as possible. Randomization should not be done if treatment visits cannot be completed prior to 23 6 weeks 5.3. Staffing Periodontal baseline examinations are attended by a study Clinical Examiner, who is a licensed dental hygienist, periodontal resident, or periodontist. All clinical examiners will be trained in study procedures and calibrated prior to commencement of the study by the UNC School of Dentistry. Section discusses the training and certification requirements of dental examiners. Follow-up training via telephone conference calls with the Data and Statistical Coordinating Center (DSCC) and/or additional training at each site with the site Project Coordinator will continue during the study. In addition to the Examiner, another individual must be trained by the examiner to function as a recorder during the examinations. The recorder must be present during the Periodontal Examination to enter the examination data into the MOTOR Dental Data Entry System (DDES). The DDES is an interactive program contained on a study laptop for entry of all periodontal scores and measures obtained during the examination. CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-1

2 5.4. Procedures and Forms The following procedures and data collection forms are required at the Baseline Periodontal visit: Dental Baseline History Form (DBH) Baseline Examination o Vital Signs o Medical and Medication History o Periodontal Baseline Examination Form (DBE) o Baseline Oral Exam o Dental Baseline Exam Recommendation From (DRB) o Periodontal Examination (see 5.6 for full description) o Specimen Collection Packet #2 o Plaque Specimen Collection o Dental Data Entry System (DDES) or Emergency DDES Form Note: Specimens are to be collected only on participants who have given consent for collection Dental Baseline History Form (DBH) The Dental Baseline History (DBH) form is administered via interview by the Examiner prior to examination. The DBH form includes a short series of questions designed to assess the dental history of the participant. Refer to the DBH QXQ s for specific instructions on completing this data collection form. Data can be recorded on a DBH paper form for timely data entry or the data can be entered interactively during the participant visit on the MOTOR laptop computer. Dental Baseline History Form ID: Form: DBH Ver: A Visit #: Seq #: Name: Staff ID: Date: / / 20 Instructions: Complete form at the Periodontal Baseline Visit. Information is obtained through participant interview. Responses that are unknown or refused are coded U. 1. Do you have regular dental checkups at least every 2 years? Y N U 2. How long has it been since you last had a dental examination? (circle one) 1 = Within the last 6 months 2 = Within the last year 3 = About 1-3 years ago 4 = More than 3 years ago 5 = I don t remember 6 = Never 3. How long ago did you last have your teeth cleaned? (circle one) 1 = Within the last 6 months 2 = Within the last year 3 = About 1-3 years ago 4 = More than 3 years ago 5 = I don t remember 6 = Never 4. Have you ever been told that you have gum disease? Y N U If YES, Have you ever had gum treatment? Y N U If Yes, Date: / Have you ever had gum surgery? Y N U If Yes, Date: / mo. year you think you are having any gum problems Y N U 5. Do now? ID: Form: DBH Ver: A Visit #: Seq #: 10. Have you lost any of your natural teeth? Y N U If YES, did you lose any teeth because of? (check all that apply) a. Cavities b. Gum disease c. Accident (trauma) d. Wisdom teeth pulled e. Extraction due to overcrowding (braces) f. Other 11. Have you had any of the following oral conditions? Within past Within the Condition (check only one box per condition) 3 months last Ever Never Don t year Know a. Tooth ache b. Sore and swollen gums c. Bleeding gums d. Sore or sensitive tongue e. Chronic bad breath f. Cold/canker sores g. Teeth sensitive to cold or heat h. Gum boil (abscess) i. Loose teeth 12. Have you had any of the following oral procedures? 6. Do your gums hurt or bleed when brushing your teeth? Y N U 7. How often do you brush your teeth? (circle one) 1 = Not everyday 2 = Once a day 3 = Twice a day 4 = More than twice a day 8. How often do you floss your teeth? (circle one) 1 = Not every week 2 = Once a week 3 = More than once a week 4 = Everyday 5 = Never 9. Do you brush your tongue? Y N U Oral procedures (Only one checked box per procedure) a. Fillings b. Tooth cleaning (scaling for gum disease) c. Crowned teeth (caps) and/or bridges d. Removable partial dentures /appliances e. Root canal f. Dental implant G Gum surgery (for gum disease) h. Surgery for tumor or other condition of your mouth or lips i. X-ray treatment for tumor or other condition of your mouth or lips Within past Within the 3 months last Ever Never Don t year Know CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-2

3 5.6. Baseline Dental Examination Each Motor participant should have a study chart containing copies of data collection forms. Screens from the MOTOR DMS can be printed and saved in the chart, for those data collection forms entered interactively. These charts should be available at the dental examination. In addition, each center should also use the medical history form that their dental institution uses to evaluate treatment considerations in the clinical setting. This form is not considered study data, and does not replace any of the study data collection forms. It should be considered part of the patient s clinical chart and updated with each dental treatment or examination visit Vital Signs Participant vital signs are to be measured prior to oral examination. Vital signs include pulse, and blood pressure. Hypertension and guidelines for continuing the dental exam will be determined according to the Center s local protocol. If the physician or the protocol recommends stopping the visit, the dental exam should not be attempted. It may be possible to reschedule the dental exam on another day if the blood pressure and/or pulse of the participant have changed to acceptable levels. Vital signs are considered clinical data (as opposed to study data) and are kept in the participant s study clinical chart. Section contains a sample form that can be used for chart recording Medical and Medication History Prior to the baseline oral and periodontal examinations, the Examiner must review the participant s medical history and interview the participant for current medical history and medication use that would contraindicate probing. Medical and medication history should be obtained according to each sites Institutional requirements. Section contains a sample form that can be used for chart recording Soft Tissue Exam The Baseline Oral Exam contains a soft tissue screening. This screening is done as a service to the participant, looking for any suspicious lesions or conditions that should be referred to a dentist. This soft-tissue screening examination is performed with gauze and a mirror. It covers the following areas: Upper and lower lips, including Vermillion border. Labial mucosa. Buccal mucosa from the maxillary vestibule to the mandibular vestibule. Cheek palpation. Mucosa of hard and soft palate. Uvula, tonsillar pillars, mandibular retomolar pad, and posterior pharyngeal wall. Dorsal surface of tongue. Ventral surface of tongue and anterior floor of mouth. CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-3

4 Findings are recorded as normal or abnormal. This information is recorded on Periodontal Baseline Exam Form (DBE) and in the Dental Data Entry System (DDES). Abnormal findings will be described to the patient with respect to location and size, (severity). Participants who present with obvious dental pathology will be provided with documentation for referral purpose, in a report from the DDES. These findings are to be noted on the Dental Baseline Exam Recommendation Form (DRB) (see study Website for copy of form) and given to the patient. No radiographs are expected to be taken at this exam, and are not required for study participation QTS System MOTOR data collection utilizes the QTS System for site nomenclature. QTS (Quadrant - Tooth - Site) utilizes a 3-digit code for charting purposes. The first digit of this code corresponds to the quadrant with the UR = #1) UL = #2, LL = #3 and LR = #4. The second digit in this code corresponds to the tooth. Teeth are numbered 1-8 beginning at the midline and counting distally. The third digit corresponds to site designation and is numbered 1-6 beginning at the mesio-buccal site of each tooth, numbering the sites distally and peripherally around each tooth, and ending with site #6 at the mesio-lingual site Facial 2 Mesial Lingual Distal Periodontal Baseline Examination Form ID: Form: DBE Ver: B Visit #: 02 Seq #: Periodontal Baseline Exam Form (DBE) The Periodontal Baseline Exam Form (DBE), documents procedures taking place during the baseline 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. The sites for plaque sampling recorded in question #3, are identified to the examiner in the Dental Data Entry System (DDES) at the end of the examination. It is important that these sites are recorded onto the DBE Name: Staff ID: Date: / / 20 Instructions: Complete this form at the Periodontal Baseline Visit during the periodontal examination. 1. Contraindications to probing based on standard medical/medication history? Y N If YES, examination cannot be performed, report to Study Coordinator. 2. Plaque Collection (at end of examination) (sample sites in quadrant order, placing plaque into the appropriate tube from Plaque Specimen Collection Packet #2, as indicated below) Indicate sampled sites: Quadrant _ 1 tube #201 (record site off DDES using QTS) Quadrant _ 2 tube #202 Quadrant _ 3 tube #203 Quadrant _ 4 tube #204 Subgingival Calculus Code (circle one): 1 = no deposits 2 = light amount of deposits (scattered, i.e deposits) 3 = moderate amount of deposits (½ mouth has calculus present) 4 = heavy amount of deposits (almost all teeth) 3. Place extra specimen ID label from Plaque Specimen Collection Packet #2 in the box below. Enter specimen ID number on label into MOTOR DMS. Label from collection packet #2 here 4. Comments Y N CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-4

5 from the DDES before ending the DDES session Periodontal Examination Clinical periodontal parameters will be collected for all teeth, including 3 rd molars. Clinical parameters will be measured using a manual UNC-12 probe. Assessments will include: Tooth Status The first pass through the mouth is to identify tooth status for each tooth. Start in Quadrant 1, tooth #8 and proceed to tooth #1. Next, move to Quadrant 2, tooth #1 and continue to tooth #8, followed by Quadrant 3, tooth #8 #1; and then Quadrant 4, tooth #1 #8. For each tooth, the operator will make a call based on whether the tooth is present and the health/condition of the tooth. For example, if the tooth is not present then it will be called missing. The following codes will be used to identify tooth status. After calls have been made for each of the 32 teeth, then you can hit the page down key. After you press the Page Down key, the computer will identify missing teeth on all subsequent data entry screens. Tooth Status Codes: 1 missing 2 present with natural crown 3 restored with a fabricated crown 4 implant (this tooth will be treated as missing by the computer) 5 decayed root fragment 6 sound root fragment Gingival Index (GI): Loe & Silness This index is scored on both the facial and lingual surfaces. Mesiobuccal to distobuccal surfaces are examined by placing the periodontal probe under the gingival margin 1 mm at the mesiobuccal line angle and swept along the buccal surface to the distobuccal line angle. After the quadrant is swept, calls are made based on gingival inflammation and the presence or absence of bleeding. For lingual surface calls, the probe is placed at the mesiolingual line angle 1 mm below the gingival margin. The probe is then swept to the distolingual line angle. After the quadrant has been swept, the gingival tissues are characterized according to the criteria which ranges from a 0 to 3. 0 = Normal gingiva 1 = Mild inflammation: slight change in color, slight edema. No bleeding on probing. 2 = Moderate inflammation: redness, edema, and glazing. Bleeding on probing. CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-5

6 3 = Severe inflammation: marked redness and edema. Ulceration. Tendency to spontaneous bleeding. The sequence of examination for GI measurements is: Quadrant 1: teeth 8-1 Quadrant 2: teeth 1 8 Quadrant 2: teeth 8 1 Quadrant 1: teeth 1-8 Quadrant 3: teeth 8-1 Quadrant 4: teeth 1 8 Quadrant 4: teeth 8 1 Quadrant 3: teeth Plaque and Stain Score (PS) Plaque scores will be recorded for both the facial (3 sites) and lingual (1 site) surfaces of each tooth. The scores are determined based on a 0-3 scale. The tooth surface to be scored should be air dried and not disclosed. Plaque index readings are called for the distofacial, facial, mesiofacial, and mid-lingual surfaces. The plaque score is recorded in the appropriate boxes for each tooth on the computer screen. 0 = absence of plaque or stain of the clinical crown 1 = deposits covering less than one-third of the surface 2 = deposits covering less than 2/3 of the surface 3 = deposits covering more than 2/3 of the surface Probing Depth, recessing CEJ, and Bleeding on Probing Probing Pocket Depth: A manual periodontal probe (UNC-12) will be used to record probing pocket depth (PD) at 6 sites per tooth, on all teeth present in the mouth. PD will be measured from the free gingival margin to the base of the pocket, and will be recorded in whole millimeters (rounded up to the nearest millimeter.) CEJ: A manual periodontal probe is used to record recession (REC) at 6 sites per tooth, on all teeth present in the mouth or isolated teeth. Recession will be measured from the cemento-enamel junction (CEJ) to the gingival margin and will be recorded in whole mm (rounded up to the nearest millimeter.) REC will be recorded as a positive value if the gingival margin occurs coronal to the CEJ, and as a negative value if it occurs apical to the CEJ. Bleeding on Probing: Bleeding upon Probing will be assessed during and recorded after probing measures are taken for each quadrant. The examination sequence for measurement is as follows: Probing depth is measured first and recorded on the computer screen for the site. For the same site, the CEJ measurement is made and then the cursor moves to the next CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-6

7 site. The measurements start in Quadrant 1, tooth 8 and moves from sites 3 (distobuccal) to 1 (mesiobuccal) on each tooth. At the end of quadrant 1, bleeding for the sites just probed is recorded. Measures then move to Quadrant 2, tooth 1, and moves from sites 1 (mesiobuccal) to 3 (distobuccal). Bleeding for the sites just probed in Quadrant 2 is recorded. Lingual sites for Quadrant 2, teeth 8 to 1 are then measured for sites 4 (distolingual) to 6 (mesiolingual). Bleeding is then recorded for sites just measured. Quadrant 1, teeth 1 to 8, sites 6 (mesiolingual) to 4 (distolingual) are then measured and bleeding recorded. The same procedure is then repeated for Quadrants 3 and 4. The cursor on the screen moves in the appropriate sequence. Quadrant Teeth Sites 1 8 to 1 Db to Mb Record BOP 2 1 to 8 Mb to Db Record BOP 2 8 to 1 Dl to Ml Record BOP 1 1 to 8 Ml to Dl Record BOP 3 8 to 1 Db to Mb Record BOP 4 1 to 8 Mb to Db Record BOP 4 8 to 1 Dl to Ml Record BOP 3 1 to 8 Ml to Dl Record BOP Subgingival Calculus Code This calculus code is used to measure the amount of generalized subgingival calculus within the participant s mouth. This should be performed at the end of the dental baseline examination, after plaque collection. The code will be recorded on the DBE form and not in the DDES. However the code will be entered into the data management system (DMS) with the recording of the form. To perform the measurement the examiner should use a universal explorer; like the ODU 11/12 and exploratory strokes. All subgingival surfaces of the teeth must be explored to determine the presence or absence of calculus. 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. Once the amount of subgingival calculus has been determined it should be recorded on the DBE form. The calculus codes include the following: 1 - no deposits 2 = light deposits (scattered, i.e deposits) 3 = moderate amount of deposits (calculus present on half of the teeth present) 4 = heavy amount of deposits (calculus present on almost all teeth) CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-7

8 Plaque Specimen Collection Plaque Specimen Collection Packet #2 Samples are collected using Collection Packet #2, containing pre-labeled bar-coded, plaque sample collection kits and vials (numbered ) with clear or white caps, provided to each center. Sterile TE buffer (supplied by UNC) and NaOH must be aliquoted into each tube prior to placement of the sample. The collection packet also contains extra pre-coded labels ending in 000 ; one of these is the paperwork label to be affixed onto the DBE form in the space provided. This provides the data link between the sample ID number and the participant ID number Procedures for Plaque Sampling Subgingival plaque samples will be collected from the deepest subgingival area with a periodontal scaler. These samples are taken from the deepest pocket in each quadrant and placed in 100 µl of TE buffer and 100 µl of freshly made 0.5 M NaOH. Sampling is to be done after the periodontal examination is completed. Sites designated for sampling are identified to the Examiner in a report from the Dental Data Entry System (DDES), run at the completion of the examination entry. In the event the DDES is either unavailable or fails, the plaque samples will still be collected. In order to identify where to take the samples, locate the deepest pocket in each quadrant, excluding tooth # 8, and collect the plaque from that site. If there is a tie between two or more teeth, in one quadrant, take the sample from the most distal site, excluding tooth # 8. If two or more sites tie for the deepest pocket on the same tooth then site for sampling should be from the most distal site. If the tie for the deepest pocket depths differs between lingual and facial then the facial site should be sampled. These sites must then be documented onto the DBE form. Sites must be sampled in quadrant order and tube order, such that the sample from quadrant 1 is placed in tube #201, quadrant 2 in tube # 202, etc UNC will provide each site with sterile TE (Tris-EDTA) buffer on a periodic basis. This buffer is stable at room temperature. Using a Repipet device (also to be provided by UNC) add 0.1mL (100uL) of TE buffer to each of these vials prior to plaque sampling (0-72 hours would be best occasional evaporation from some tubes has been experienced in prior studies). To sample, the site is isolated with a cotton roll and removed of gross supragingival plaque or debris if present and gently dried with sterile gauze or air stream. Plaque samples will be taken by placing a sterile curette to the base of each pocket and, with a single exploratory stroke, pressing against the tooth at the depth of the pocket, removing a sample for transfer to the storage buffer. Do not attempt to sample the grossly adherent plaque which appears supragingivally. Using care to make sure the plaque sample from quadrant 1 goes into vial 201, quadrant 2 into 202 etc., swish the end of the curette in the droplet of TE buffer so that the plaque is visibly transferred into the buffer for each of the tubes. Place the tip of the curette into the TE buffer, and twirl the curette between your fingers to remove plaque. CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-8

9 If a particularly heavy deposit adheres to the curette, it may be removed by scraping onto the upper lip of the tube, and then pushing the sample down into the buffer. However, in general, sufficient bacteria will be transferred to the buffer for DNA analysis, even if not visible by eye. Then, using a different Repipet device, clearly labeled for NaOH (Sodium Hydroxide) add 0.1 ml of the NaOH to each collection vial, cap tightly, and vortex to achieve good mixing of the buffer and the NaOH. Personnel should use caution whenever working with the NaOH as this is a strong base and can cause burns on skin and clothing. This procedure is repeated for the remaining 3 quadrants. Samples for each quadrant are placed in separate appropriately labeled vials. 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 Dental Data Entry System All scores and measures are entered interactively into the MOTOR Dental Data Entry System (DDES) by a clerical assistant using a study laptop containing the MOTOR DDES. The User s Guide contains detailed information on how to maneuver in the system, the ordering of measures, quadrant and teeth, and on any reporting features that are part of the system. In the event that there is equipment failure, emergency paper forms are available for use in recording the examination. This set of forms is called Periodontal Exam Back-up Data Entry Form (form code PER). Copies of these forms can be found on the MOTOR Web Site and in the Studies Documentation Notebooks. Detailed instructions on how to select sites for plaque sampling are included on the emergency paper form. Paper forms data can then be entered using the DDES when available. The periodontal exam data entered onto the laptop using the local entry system must be must be uploaded from the local DMS on the laptop to the Web database using the appropriate utilities (see DMS User s Guide) in order for this data to get into the study database. CHAPTER 5: Periodontal Baseline Visit 9/28/06 Page 5-9