Periodontal Disease Prevention Study

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

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."

Study Overview

• Status: Completed
• Conditions: Periodontitis

• Study Type: Observational
• Enrollment (Actual): 5117

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Michigan Center for Oral Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 34 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Low Risk Experimental Group; 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; 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; 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; 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?

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	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

Collaborators and Investigators

• Sponsor: University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: periodontitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: HUM00037624

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No