Recruiting NA Gingivitis

New treatment option for Gingivitis

Official title Variation in Gingival Inflammatory Responses

ClinicalTrials.gov ID: NCT05968742

What this study is testing

What it's testing
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.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 35. Healthy volunteers may be eligible.

You may be able to join 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...

You likely can't join if

  • Medical condition which requires premedication prior to dental treatments/visits
  • people 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.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • Medical condition which requires premedication prior to dental treatments/visits
  • people 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
  • people 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)

The study team makes the final eligibility decision.

Where it's taking place

  • Seattle, Washington, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.