Periodontal Disease Prevention Study

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584479
• Other study ID #: HUM00037624
• Status: Completed
• Phase: N/A
• First received: April 12, 2012
• Last updated: June 17, 2015
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5117
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 34 Years to 55 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Locations

Country	Name	City	State
United States	Michigan Center for Oral Health Research	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Total Dental Claims During Monitoring Period		10 and 15 years	No
Secondary	Change in Total Periodontal Claims During the Monitoring Period		10 and 15 years	No
Secondary	Change in Periodontal Surgery Claims		10 and 15 years	No
Secondary	Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.		10 and 15 years	No
Secondary	Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories		10 and 15 years	No