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Periodontal Disease Prevention Study

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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:
Information provided by (Responsible Party):
William Giannobile, University of Michigan

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

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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

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 (+)




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


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584479


Locations
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United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: William V Giannobile, DDS, DMedSc University of Michigan

Publications of Results:
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Responsible Party: William Giannobile, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01584479     History of Changes
Other Study ID Numbers: HUM00037624
First Posted: April 25, 2012    Key Record Dates
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:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases