Actively Recruiting
Variation in Gingival Inflammatory Responses
Led by University of Washington · Updated on 2025-11-13
80
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 accumulation and maturation of dental plaque.
CONDITIONS
Official Title
Variation in Gingival Inflammatory Responses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Gingival Index of < 2 and no sites with a score of 3; < 10% sites with bleeding on probing)
- 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.
You will not qualify if you...
- 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)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
M
Marilynn Rothen, RDH, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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