Development of Inflammatory Disease Model Protein, Genetic and Microbial Biomarkers

Completed

Conditions studied: Healthy

In brief

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 found at higher levels in areas of inflammation. This type of study is called an experimental gingivitis study. It will involve stopping your routine oral health care for 21 days. If you qualify, you will receive a full dental cleaning at the beginning and end of the study. Approximately 30 patients will participate in this study at the Michigan Center for Oral Health Research (MCOHR).

Key facts

Study ID

NCT00980525

Run by

University of Michigan

People needed

32

Starts

2009-05-01

Expected to finish

2010-04-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Michigan Center for Oral Health Research — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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