29 May Studying Induced Gingivitis
The purpose of the study is to gain a deeper understanding of how bacteria cause bleeding gums (gingivitis). Gingivitis is the result of normal dental plaque accumulation, however, gingivitis is easily reversed by cleaning away the dental plaque. The study will evaluate the effects of normal plaque accumulation surrounding the gum tissues when oral hygiene is stopped on 4 teeth in a section of the mouth for 21 days and gingivitis develops. There are 7 study visits over a seven week period. Pre-screening visit will be required. The study team will collect bio-specimens (saliva, fluid from between the teeth and gums, plaque), measure gum tissues, make a dental impression of teeth, provide a teeth cleaning by a dental hygienist, and offer an optional blood draw sample. Eligible participants may earn up to $590 for their time.
Participant Eligibility
Inclusion Criteria:
Provide signed and dated informed consent form
Willing to comply with all study procedures and be available for the duration of the study
Male or female, aged 18-35 years
Good general health
No clinical signs of gingival inflammation
Never smokers
The ability to understand and communicate with the examiner.
Willing and able to comply with study procedures.
Exclusion Criteria:
Medical condition which requires premedication prior to dental treatments/visits
Subjects unable or unwilling to sign the informed consent form
History of periodontal disease
History of systemic inflammatory or immune conditions, Diabetes
Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment
Self-reported pregnancy, planned pregnancy during the planned study commitment, and/or breastfeeding at the time of screening.
Concurrent orthodontic treatment
Untreated cavities or inadequate tooth restorations
Participation in any other clinical study or test panel within 1 week prior to enrollment into this study
Use of chewing tobacco products
Subjects who must receive dental treatment during the study dates
Orthodontic bands, appliances, or crowns and bridges, or removable partial dentures affecting the maxillary posterior teeth
Missing tooth/teeth on the upper jaw (except wisdom teeth)
History of allergy to common toothpaste ingredients
Immune-compromised individuals (for example: HIV, AIDS, and immune-suppressive drug therapy)
Contact
Mary K Hagstrom
(206) 685-8132
Additional Study Details
Full Study Title
Mechanisms underlying the variation in rate and levels of gingival inflammatory responses among the human population
Investigator(s)
Jeffrey S McLean, PhD, Diane Daubert, PhD, Kristopher A. Kerns, PhD, Yung-ting Hsu, DDS
Accepts Healthy Volunteers?
Yes
Study Site(s)
University of Washington
1959 NE Pacific Street Regional Clinical Dental Research Center D453
Seattle, Washington 98195