Thyroid Disease and Chronic Periodontitis

• ClinicalTrials.gov Identifier: NCT03369405
• Recruitment Status: Active, not recruiting
• First Posted: December 12, 2017
• Last Update Posted: September 2, 2021
• Sponsor: University at Buffalo
• Information provided by (Responsible Party): Dr. Lisa Yerke, University at Buffalo

Study Description

Brief Summary:

Currently, the investigators are unaware of any previous studies that have analyzed the relationship between the prevalence of thyroid disease and chronic periodontitis among adults utilizing a retrospective, cross-sectional design. This study will review approximately 2000 patient records and compare the prevalence of thyroid disease in three groups with increasing severity of chronic periodontitis.

Condition or disease	Intervention/treatment
Thyroid Diseases; Chronic Periodontitis	Other: NO intervention, patient records review only

Detailed Description:

This is a retrospective, cross-sectional patient records review study. Only records with subjects that were 35 years or older and have been active patients of the School of Dental Medicine, University at Buffalo will be included. Three individual searches with three distinct patient criteria will be conducted to obtain records from subjects in three populations with different degrees of periodontal disease. All subjects that qualify the eligibility criteria will be selected. The IT Department has access to select the subjects according to the eligibility criteria without requiring access to the physical patient record. The three subject groups are:

1. Periodontally healthy patients: Patients with a D1110 or D1111 (adult prophylaxis including those with 6 or fewer teeth) treatment code, seen by a 3rd or 4th year pre-doctoral dental student. Excludes all charts that have ever had a U4990 (Perio case) treatment code. Patient is 35 years or older relative to 1/1/2016.
2. Patients with a history of advanced periodontal treatment, group 1: All patients treated in the Postgraduate Periodontics department by a periodontics resident between 1/1/2000 - 12/31/2017. Patients presenting for treatment of chronic periodontitis will be included while those patients presenting to the clinic for other reasons, such as crown lengthening procedures, will be labeled as such. All patients selected will be 35 years or older at time of initial exam.
3. Patients with history of advanced periodontal treatment, group 2: All patients ever treated in the private faculty practice of one periodontist, that were still active patients during between 1/1/16 - 12/31/16. Only those 35 years and older were included. Patients presenting for treatment of chronic periodontitis will be included while those patients presenting to the clinic for other reasons, such as crown lengthening procedures, will be labeled as such.

All duplicates within a group will be excluded (e.g. patients may have had a D1110 code more than once per year). These 3 subject search criteria should yield a sufficient number of patient records for statistical analysis.

All patient records will be reviewed and data will be collected and recorded in an electronic Microsoft Excel database file that is saved on an encrypted flash drive. The only patient identifier recorded will be the patient records number. Once data collection is complete, or at a maximum of 3 years from the start of the study, all identifying information will be deleted and only de-identified data saved on a separate electronic file will be analyzed. No code key will be required.

Data will be analyzed using ANOVA (F-test). If multiple variables are used, analysis will be by using generalized estimating equations (GEE).

Study Design

• Study Type: Observational
• Estimated Enrollment: 2000 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Thyroid Insufficiency as a Modifying Factor for Chronic Periodontitis
• Actual Study Start Date: February 2, 2018
• Estimated Primary Completion Date: August 1, 2022
• Estimated Study Completion Date: August 1, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Periodontally healthy patients; Patients that have no history of periodontal treatment and that have been scheduled for routine prophylaxis appointments in the predoctoral clinics at the School of Dental Medicine, University at Buffalo.	Other: NO intervention, patient records review only; There is no intervention - the three study groups are created by utilizing three unique sets of search criteria for the patient records review.
Periodontitis, group 1; Patients that have been referred from the pre-doctoral dental clinics to the Postgraduate Periodontics clinic for advanced periodontal disease. Clinical attachment loss, pain, mobility, bleeding, suppuration, and probing depths > 4 mm more likely to be prevalent.	Other: NO intervention, patient records review only; There is no intervention - the three study groups are created by utilizing three unique sets of search criteria for the patient records review.
Periodontitis, group 2; Patients referred to a faculty practice periodontist over the course of his clinical career due to chronic periodontitis that could not be treated by the referring general dentist. Clinical attachment loss, pain, mobility, bleeding, suppuration, and probing depths > 4 mm more likely to be prevalent.	Other: NO intervention, patient records review only; There is no intervention - the three study groups are created by utilizing three unique sets of search criteria for the patient records review.

Outcome Measures

Primary Outcome Measures :

1. Thyroid disease prevalence [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   The presence or absence of thyroid medication in the patient record will be used as a surrogate marker for thyroid disease presence or absence.

Secondary Outcome Measures :

1. smoking history [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   Smoking history will be determined from the Medical Questionnaire form in the patient records.
2. diabetes disease prevalence [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   The Medical Questionnaire and the Medication List in the patient records will be referenced to determine the presence of diabetes.
3. Periodontal Probing Depths 5mm or greater [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   Number of teeth that have one or more sites that contain a 5mm or greater pocket, recorded in periodontal chart
4. Periodontal Probing Depths 6mm or greater [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   Number of teeth that have one or more sites that contain a 6mm or greater pocket, recorded in periodontal chart
5. Teeth [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   Total number of teeth, recorded in periodontal chart
6. proton pump inhibitor use [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   The Medication List in the patient records will be referenced to determine any history of proton pump inhibitor use.
7. Plaque Score [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   Percentage of tooth surfaces positive for plaque out of total tooth surfaces
8. Hormone replacement therapy [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   The presence or absence of hormone supplementation (birth control or hormone replacement therapy included)
9. bisphosphonate use [ Time Frame: Assessed at one time point only, during patient's initial exam noted in patient records (cross-sectional study). ]
   The Medication List in the patient records will be referenced to determine any history of bisphosphonate use.

Eligibility Criteria

• Ages Eligible for Study: 35 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

The study population is sampled from the patient records available at the School of Dental Medicine, University at Buffalo, State University of New York. The patient records reviewed will be of patients seen in the predoctoral as well as postgraduate clinics.

The third group population is sampled from the patient records available from the faculty practice of one provider located at the University of Buffalo, State University of New York

Criteria

Inclusion Criteria:

• Active patient of the School of Dental Medicine, University at Buffalo.

• The remaining eligibility criteria varies between the three distinct subject populations, which are noted below. All eligibility criteria is selected for by an electronic search of patient records performed by the IT Department at the School of Dental Medicine, University at Buffalo.

  1. Periodontally healthy patients:

     1. A treatment code of D1110 or D111 was processed at least once but excluding patients that were ever assigned a treatment code of U4990
     2. A 3rd or 4th year pre-doctoral dental student provider
     3. 35 years or older as of 1/1/2016
     4. Patient presented to clinic between 1/1/2016-12/31/2016

  2. Patients with history of advanced periodontal treatment, group 1:

     1. All patients presenting to the Postgraduate Periodontics Department at UB and being seen by a periodontics resident
     2. Time period between 1/1/2000-12/31/2017
     3. Patients will be 35 years or older at time of initial exam
     4. Patients presenting for reasons other than chronic periodontitis treatment (e.g. crown lengthening) will be labeled as such.

  3. Patients with history of advanced periodontal treatment, group 2:

     1. All patients treated in the faculty practice of one periodontist that remained active patients during the time period 1/1/2016-12/31-2016
     2. All patients were 35 years or older at time of initial exam

Duplicates within groups are eliminated.

Exclusion Criteria:

• inadequate data from records

Note: the majority of patient records selected by the search criteria done electronically by the IT department will be included in the study, since the search criteria very closely overlaps the overall study criteria

Contacts and Locations

Locations

United States, New York

School of Dental Medicine, University at Buffalo

Buffalo, New York, United States, 14214

Sponsors and Collaborators

University at Buffalo

More Information

• Responsible Party: Dr. Lisa Yerke, Clinical Assistant Professor, Department of Periodontics and Endodontics, University at Buffalo
• ClinicalTrials.gov Identifier: NCT03369405
• Other Study ID Numbers: STUDY00001811
• First Posted: December 12, 2017
• Last Update Posted: September 2, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Lisa Yerke, University at Buffalo:

periodontitis; hypothyroidism

Additional relevant MeSH terms:

Periodontitis; Chronic Periodontitis; Thyroid Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases