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NCT01584479 · ClinicalTrials.gov registry record

Periodontal Disease Prevention Study

A clinical trial, sponsored by University of Michigan.

Completed
Registry status
5,117
Enrollment target

NCT01584479: Completed study, sponsored by University of Michigan.

NCT01584479 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 5,117 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01584479 has completed, sponsored by University of Michigan.

COMPLETED
Registry status
5,117 participants
Enrollment target

Study 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."

Primary Outcome

Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.

Trial Details

FieldValue
Enrollment Target 5,117 participants
Start Date 2010-12
Est. Completion 2012-03
University of Michigan

1,327 total trials

What the finished NCT01584479 record still lists

NCT01584479 is an observational study that tracks outcomes without assigning an intervention. Its 5,117 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 0 interventions.

NCT01584479 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01584479 about?

NCT01584479 is a clinical study titled "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 an...

What is the current status of trial NCT01584479?

This trial is currently completed. The enrollment target is 5,117 participants. The study started on 2010-12. Estimated completion is 2012-03.

Who is sponsoring clinical trial NCT01584479?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01584479, the US trial registry maintained by the National Library of Medicine. NCT01584479 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.