Clinical trial NCT01584479: Periodontal Disease Prevention Study
Official title: Periodontal Disease Prevention Study:A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Keywords: periodontitis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 5117
Sex: ALL
Minimum age (years): 34
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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."


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.

Primary outcomes:
measure: Percentage of Participants With Tooth Loss Over 16 Year Period
timeFrame: 16 years
Secondary outcomes:
measure: Change in Total Dental Claims During Monitoring Period
timeFrame: 10 and 15 years
measure: Change in Total Periodontal Claims During the Monitoring Period
timeFrame: 10 and 15 years
measure: Change in Periodontal Surgery Claims
timeFrame: 10 and 15 years
measure: Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.
timeFrame: 10 and 15 years
measure: Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories
timeFrame: 10 and 15 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: William V Giannobile, DDS, DMedSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giannobile WV, Braun TM, Caplis AK, Doucette-Stamm L, Duff GW, Kornman KS. Patient stratification for preventive care in dentistry. J Dent Res. 2013 Aug;92(8):694-701. doi: 10.1177/0022034513492336. Epub 2013 Jun 10.