- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00569075
Apoptic Biomarkers of Periodontal Disease
May 9, 2017 updated by: University of Michigan
Apoptotic Biomarkers of Periodontal Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- Michigan Center for Oral Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
healthy adults with healthy gums or those with periodontitis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
High Risk
High risk disease prone population
|
GCF samples will be collected at 3 month intervals
|
|
Low Risk
Low risk disease population
|
GCF samples will be collected at 3 month intervals
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yvonne Kapila, DDS, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
December 5, 2007
First Submitted That Met QC Criteria
December 5, 2007
First Posted (Estimate)
December 6, 2007
Study Record Updates
Last Update Posted (Actual)
May 10, 2017
Last Update Submitted That Met QC Criteria
May 9, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.