RECRUITING

Variation in Gingival Inflammatory Responses

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-30

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05968742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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)

Inclusion Criteria

Exclusion 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.

* 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)

Contacts and Locations

Study Contact

Marilynn Rothen, RDH, MS

CONTACT

206-685-8132

rothen@uw.edu

Principal Investigator

Jeffrey S McLean, PhD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: University of Washington

Jeffrey S McLean, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-30

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-06-30

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Experimental Gingivitis

Additional Relevant MeSH Terms

Gingivitis