Status:
RECRUITING
Variation in Gingival Inflammatory Responses
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Gingivitis
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
The aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded study is to identify molecular mechanisms underlying observed variations in human responses to natural accumul...
Detailed Description
This study will employ the split-mouth Experimental Gingivitis model where healthy study participants are asked to abstain from oral hygiene on a select set of teeth (test teeth) for a period of 21 da...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05968742
Start Date
June 30 2023
End Date
December 31 2027
Last Update
November 13 2025
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195