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Apoptic Biomarkers of Periodontal Disease

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ClinicalTrials.gov Identifier: NCT00569075
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : May 10, 2017
Sponsor:
Information provided by:
University of Michigan

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The goal of this study is to facilitate early diagnosis of gum disease. Proteins associated with cell death will be isolated from gum pockets of diseased and healthy patients and evaluated.

Condition or disease Intervention/treatment
Periodontitis Other: collection of gingival crevicular fluid

Detailed Description:
Early detection of the progression of periodontitis is difficult because it typically relies on comparisons of clinical measurements made with a calibrated probe and nonstandardized radiographs over time. Both methods detect periodontal breakdown only after it has occurred. Therefore, considerable emphasis has been placed on identifying more specific and sensitive methods to diagnose and detect periodontal disease progression. The overall goal of this project is to determine whether specific apoptosis-associated proteins, specifically fibronectin (FN) fragments, caspase-3, soluble Fas, and soluble Fas ligand, sampled from gingival crevicular fluid (GCF) can be used as markers for periodontal disease progression.

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Apoptotic Biomarkers of Periodontal Disease
Study Start Date : October 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
High Risk
High risk disease prone population
 Other: collection of gingival crevicular fluid
GCF samples will be collected at 3 month intervals
Low Risk
Low risk disease population
 Other: collection of gingival crevicular fluid
GCF samples will be collected at 3 month intervals


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA
saliva and plaque

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy adults with healthy gums or those with periodontitis
Criteria

Inclusion Criteria:

  • Adults over age of 18
  • Healthy or diagnosis of periodontitis

Exclusion Criteria:

  • Active treatment with anti-inflammatory agents such as NSAIDs or steroids and pregnant females
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00569075


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: Yvonne Kapila, DDS, PhD University of Michigan
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yvonne Kapila, University of Michigan
ClinicalTrials.gov Identifier: NCT00569075     History of Changes
Other Study ID Numbers: 2004-04
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by University of Michigan:
Apoptic biomarkers
Early detection periodontitis
Gingival crevicular fluid
Healthy subjects

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases