Apoptic Biomarkers of Periodontal Disease

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00569075
First received: December 5, 2007
Last updated: June 24, 2010
Last verified: February 2009
  Purpose

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 Intervention Phase
Periodontitis
Other: collection of gingival crevicular fluid
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Apoptotic Biomarkers of Periodontal Disease

Further study details as provided by University of Michigan:

Biospecimen Retention:   Samples Without DNA

saliva and plaque


Enrollment: 60
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: collection of gingival crevicular fluid
    GCF samples will be collected at 3 month intervals
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yvonne Kapila, University of Michigan
ClinicalTrials.gov Identifier: NCT00569075     History of Changes
Other Study ID Numbers: 2004-04
Study First Received: December 5, 2007
Last Updated: June 24, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014