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Completed

NCT Number: NCT01584479

Periodontal Disease Prevention Study

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."

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Key information

Age range

34 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 25, 2012
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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