Periodontal Disease Prevention Study

NCT01584479 | Completed Results

• 1 other identifier: HUM00037624
• Study Type: observational
• Target: 5,117
• Locations: 1 country
• Sites: 1

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."

Conditions

Periodontitis

Keywords

periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (4)

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 (+)

Eligibility Criteria

• Age: 34 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Organ transplant recipients are excluded.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related 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.

  PMID: 23752171 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

buccal swabs

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: William Giannobile, Principal Investigator
• Organization: University of Michigan

wgiannob@umich.edu

734-764-1562

Study Officials

• William V Giannobile, DDS, DMedSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 25, 2012
• Study Start: December 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 9, 2015
• Results First Posted: July 9, 2015

Record last verified: 2015-06

Locations

US (1)