NCT05968742 Variation in Gingival Inflammatory Responses
| NCT ID | NCT05968742 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Gingivitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-06-30 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 accumulation and maturation of dental plaque.
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)
Contact & Investigator
Jeffrey S McLean, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05968742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Gingivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05968742 currently recruiting?
Yes, NCT05968742 is actively recruiting participants. Contact the research team at rothen@uw.edu for enrollment information.
Where is the NCT05968742 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05968742 clinical trial?
NCT05968742 is sponsored by University of Washington. The principal investigator is Jeffrey S McLean, PhD at University of Washington. The trial plans to enroll 80 participants.