RecruitingNot ApplicableNCT05968742

Variation in Gingival Inflammatory Responses

Mechanisms Underlying the Variation in Rate and Levels of Gingival Inflammatory Responses Among the Human Population

Sponsor

University of Washington

Enrollment

80 participants

Start Date

Jun 30, 2023

Study Type

INTERVENTIONAL

Conditions

Gingivitis

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 accumulation and maturation of dental plaque.

Eligibility

Min Age: 18 YearsMax Age: 35 Years

Inclusion Criteria11

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 Criteria15

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)