Periodontal Disease Prevention Study

Study Overview
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Brief Summary
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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.

Official Title
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Periodontal Disease Prevention Study:A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease

Conditions
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Periodontitis

Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Organ transplant recipients are excluded.

Ages Eligible for Study
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Minimum Age: 34 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Risk Experimental Group<br>1 visit - Low Risk  1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) | |
| Low risk Control Group<br>2 visits - Low Risk  1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) | |
| High Risk Experimental Group<br>1 visit - High Risk  800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) | |
| High Risk Control Group<br>2 visits - High Risk  800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Tooth Loss Over 16 Year Period | Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years. | 16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Dental Claims During Monitoring Period |  | 10 and 15 years | 
| Change in Total Periodontal Claims During the Monitoring Period |  | 10 and 15 years | 
| Change in Periodontal Surgery Claims |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis