Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT05968742

Conditions

Gingivitis

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Abstinence of oral hygiene on select teeth

Study Details

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.

Conditions

Gingivitis

Study ID

NCT05968742

Start date

Jun 30, 2023

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteers

Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days.

The use of a custom made acrylic intraoral stent (mouthguard) will be used to protect teeth on designated test sides for each study participant during normal oral hygiene (approximately 4 minutes each day: 2 times for 2 minutes) throughout the induction phase (Day 0-21).

Interventions

Abstinence of oral hygiene on select teeth

Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days

Primary outcome measure

  • Identification of clinical responder types [ Time Frame: Day 0 to Day 21 ]

Central Contacts and Locations

Central contacts

Marilynn Rothen, RDH, MS

206-685-8132rothen@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Jeffrey S McLean, PhD

(206)-616-1808jsmclean@uw.edu

Marilyn Rothen

(206) 685-8132rothen@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • Experimental Gingivitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-11-13.