Periodontal Disease Prevention Study

Completed

• Conditions: Periodontitis

• Registration Number: NCT01584479
• Lead Sponsor: University of Michigan

Brief Summary

This study is one component of a program to improve the maintenance of good dental health and the prevention of disease by use of risk stratification methods to efficiently guide increased preventive services to adult dental patients who are at increased risk for the major dental diseases, caries and adult periodontitis.

The investigators will use a retrospective cohort model to analyze a large dental claims database to determine if the frequency of preventive services influenced the periodontal disease outcomes and to determine if periodontal risk assessment information can be used to stratify dental patients into "high risk" and "low risk" categories that influence the effect of preventive services on periodontitis outcomes.

Primary Objective To evaluate whether dental patients who are classified as "low risk" for periodontal disease progression, based on history of periodontitis (claims history), smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.

Secondary Objectives To evaluate whether dental patients who are classified as "high risk" for periodontal disease progression, based on a history of periodontitis, smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.

To evaluate whether dental patients who have had one dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk." To evaluate whether dental patients who have had two dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk."

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Results First Submitted: 2014-06-13
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-17
• Last Update Submitted: 2015-06-17
• Results First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5117

Inclusion Criteria

• Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental.

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Exclusion Criteria

• Organ transplant recipients are excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Tooth Loss Over 16 Year Period	16 years	Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.

Secondary Outcome Measures

Name	Time	Method
Change in Total Periodontal Claims During the Monitoring Period	10 and 15 years
Change in Periodontal Surgery Claims	10 and 15 years
Change in Total Dental Claims During Monitoring Period	10 and 15 years
Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.	10 and 15 years
Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories	10 and 15 years

Trial Locations

Locations (1)

Michigan Center for Oral Health Research; 🇺🇸 Ann Arbor, Michigan, United States