Periodontal Disease Prevention Study

• ClinicalTrials.gov Identifier: NCT01584479
• Recruitment Status: Completed
• First Posted: April 25, 2012
• Results First Posted: July 9, 2015
• Last Update Posted: July 9, 2015
• Sponsor: University of Michigan
• Information provided by (Responsible Party): William Giannobile, University of Michigan

Study Description

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."

Condition or disease
Periodontitis

Study Design

• Study Type: Observational
• Actual Enrollment: 5117 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Periodontal Disease Prevention Study:A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease
• Study Start Date: December 2010
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Groups and Cohorts

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 (+)

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Tooth Loss Over 16 Year Period [ Time Frame: 16 years ]
   Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.

Secondary Outcome Measures :

1. Change in Total Dental Claims During Monitoring Period [ Time Frame: 10 and 15 years ]
2. Change in Total Periodontal Claims During the Monitoring Period [ Time Frame: 10 and 15 years ]
3. Change in Periodontal Surgery Claims [ Time Frame: 10 and 15 years ]
4. Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire. [ Time Frame: 10 and 15 years ]
5. Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories [ Time Frame: 10 and 15 years ]

Biospecimen Retention:   Samples With DNA

buccal swabs

Eligibility Criteria

• Ages Eligible for Study: 34 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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.

Contacts and Locations

Locations

United States, Michigan

Michigan Center for Oral Health Research

Ann Arbor, Michigan, United States, 48106

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: William V Giannobile, DDS, DMedSc; University of Michigan

More Information

Publications of Results:

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.

• Responsible Party: William Giannobile, Principal Investigator, University of Michigan
• ClinicalTrials.gov Identifier: NCT01584479
• Other Study ID Numbers: HUM00037624
• First Posted: April 25, 2012
• Results First Posted: July 9, 2015
• Last Update Posted: July 9, 2015
• Last Verified: June 2015

Keywords provided by William Giannobile, University of Michigan:

periodontitis

Additional relevant MeSH terms:

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases