Variation in Gingival Inflammatory Responses
Gingivitis
About this trial
This is an interventional basic science trial for Gingivitis focused on measuring Experimental Gingivitis
Eligibility Criteria
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, ASA I (healthy with no systemic conditions) No clinical signs of gingival inflammation at > 90% of sites observed (whole mouth) (< 10% of sites with GI of < 2 and no sites with a score of 3; < 10% sites with BOP +). Probing depth (PD) ≤ 3.0 mm (Whole Mouth) Attachment loss (AL) = 0 mm (Whole Mouth) Gingival health at Visit 2 (Day 0) for study sites (Test/Control teeth): Average Gingival Index (GI) ≤ 0.1 with no site having a score of 3 and bleeding on probing (BOP)(-) 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 carious lesions and/or inadequate restorations on maxillary posterior teeth Participation in any other clinical study or test panel within 1 week prior to enrollment into this study Use of 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 within the study sites test and control History of allergy to common dentifrice ingredients Immune-compromised individuals (for example: HIV, AIDS, and immune-suppressive drug therapy)
Sites / Locations
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Experimental
Healthy Volunteers
Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days. The use of a custom made acrylic intraoral stent (mouthguard) will be used to protect teeth on designated test sides for each study participant during normal oral hygiene (approximately 4 minutes each day: 2 times for 2 minutes) throughout the induction phase (Day 0-21).