Understanding how gingivitis varies among individuals
Mechanisms Underlying the Variation in Rate and Levels of Gingival Inflammatory Responses Among the Human Population
This study is testing how different people's bodies react to plaque buildup on their teeth to better understand gingivitis in healthy young adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05968742 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the molecular mechanisms that contribute to differences in how individuals respond to the natural buildup of dental plaque, leading to gingivitis. Healthy participants aged 18-35 will refrain from oral hygiene on specific teeth for 21 days, allowing plaque to accumulate and trigger an inflammatory response. The study will be conducted in three phases: a hygiene phase, an experimental induction phase, and a resolution phase, to observe the onset and resolution of inflammation. By utilizing a split-mouth experimental gingivitis model, researchers hope to gain insights into the interactions between microbial factors and host responses that influence gingival inflammation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 18-35 with no signs of gingival inflammation.
Not a fit: Patients with existing medical conditions requiring premedication for dental treatments or those with signs of gingival inflammation will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and management of gingivitis, potentially enhancing oral health outcomes.
How similar studies have performed: Previous studies using similar experimental gingivitis models have shown success in understanding gingival inflammation, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey S McLean, PhD — University of Washington
- Study coordinator: Marilynn Rothen, RDH, MS
- Email: rothen@uw.edu
- Phone: 206-685-8132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.