Variation in Gingival Inflammatory Responses

NCT05968742 | Recruiting

• 2 other identifiers: STUDY00016247R01DE031470
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Experimental Gingivitis

Outcome Measures

Primary Outcomes (1)

• Identification of clinical responder types

  Identification of clinical responder types through comparative analysis of the levels of clinical parameter for Bleeding on Probing Index (% BOP) at Day 14 of the plaque overgrowth/induction phase measured by calibrated examiners.

  Day 0 to Day 21

Secondary Outcomes (1)

• Change in relative abundance of bacteria

  Day 0 to Day 21

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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).

Behavioral: Abstinence of oral hygiene on select teeth

Interventions

Abstinence of oral hygiene on select teeth BEHAVIORAL

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

Also known as: Split Mouth Experimental Gingivitis

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (1)

• Bamashmous S, Kotsakis GA, Kerns KA, Leroux BG, Zenobia C, Chen D, Trivedi HM, McLean JS, Darveau RP. Human variation in gingival inflammation. Proc Natl Acad Sci U S A. 2021 Jul 6;118(27):e2012578118. doi: 10.1073/pnas.2012578118.

  PMID: 34193520 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jeffrey S McLean, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilynn Rothen, RDH, MS

CONTACT

206-685-8132; rothen@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Longitudinal prospective clinical study using the experimental gingivitis model. Split Mouth design.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 1, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)