Status:
COMPLETED
Development of Inflammatory Disease Model Protein, Genetic and Microbial Biomarkers
Lead Sponsor:
University of Michigan
Conditions:
Healthy
Eligibility:
All Genders
18-40 years
Brief Summary
The purpose of this study is to determine if certain levels of proteins lead to inflammation of the gums. One example of such proteins being studied is called Interleukin 1 (IL-1). This protein is fou...
Detailed Description
Gingivitis is a specific oral infectious disease that affects approximately 50% of the adult population on an average of 3 to 4 teeth. Although dental plaque is the primary etiology of most periodonta...
Eligibility Criteria
Inclusion
- Caucasian subjects between 18-40 years of age (throughout the study)
- Dentition with a minimum of 20 permanent teeth
- Mean score of less than or equal to 1 for plaque index, gingival index and papillary bleeding
- Compliance with all requirements in the study and signing the informed consent
Exclusion
- Current smokers, smokers who quit less than one year ago, or a pack-year history of more than or equal to 10 (pack-years will be calculated by multiplying the number of years smoked by the average number of cigarette-packs smoked per day)
- Antibiotic therapy within 3 months of baseline or the need for antibiotics for infective endocarditis prophylaxis or other conditions
- Chronic medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications…)
- Pregnancy or lactating mothers
- Combined score of greater than 1 for plaque index, gingival index, and papillary bleeding at the screening visit
- Current orthodontic or periodontal treatments
- History of alcoholism or drug abuse
- Untreated carious lesions or defective restorations which could exacerbate during a period of oral hygiene abstinence
- Diseases of the immune system or any medical condition that may influence the outcome (diabetes, neurologic or psychiatric disorders, systemic infections…)
- New oral contraceptives users within 3 months of baseline or those planning on starting oral contraceptives during the study
- Depo-Provera contraceptive injection users
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00980525
Start Date
May 1 2009
End Date
April 1 2010
Last Update
December 3 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106