N/A
N=5,117
Periodontal Disease Prevention Study
Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT01584479 ↗Enrolled (actual)
5,117
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Percentage of Participants With Tooth Loss Over 16 Year Period — 16.4; 13.8; 22.1; 16.9 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 34+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Tooth Loss Over 16 Year Period |
16.4; 13.8; 22.1; 16.9 | — |
| SECONDARY Change in Total Dental Claims During Monitoring Period |
— | — |
| SECONDARY Change in Total Periodontal Claims During the Monitoring Period |
— | — |
| SECONDARY Change in Periodontal Surgery Claims |
— | — |
| SECONDARY Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire. |
— | — |
| SECONDARY Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories |
— | — |
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."
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01584479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.