Evaluating the link between gingivitis and systemic biomarkers

An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers

This study is testing whether improving oral hygiene can help people with gingivitis and see how it affects certain health markers in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 25 Years to 65 Years
• Sex: All
• Sponsor: Procter and Gamble (Industry-sponsored)
• Locations: 2 sites (Fort Wayne, Indiana and 1 other locations)
• Trial ID: NCT06962956 on ClinicalTrials.gov

What this trial studies

This exploratory study consists of two phases: Phase 1 focuses on sample collection and screening to understand the association between gingivitis and systemic biomarkers. Phase 2 will assess the causal effect of oral hygiene interventions on gingivitis and these biomarkers. Participants will use specific dentifrices during the intervention phase to evaluate their effectiveness. The study aims to gather data that could lead to improved oral health strategies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 25 to 65 with varying degrees of gingivitis and specific dental health criteria.

Not a fit: Patients with healthy gums and no signs of gingivitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better oral hygiene products that effectively reduce gingivitis and improve overall health.

How similar studies have performed: While this study explores a specific association, similar studies have shown promising results in linking oral health to systemic conditions.

Eligibility criteria

Inclusion Criteria:

* Provide informed consent and receive a signed copy of the informed consent form;
* Be between 25 - 65 years of age;
* Have at least 16 gradable teeth;
* Have a minimum of (approximately) 30% of bleeding sites and no more than two teeth with pockets deeper than 5mm or deemed acceptable by the Investigator/Designee (unhealthy test subjects only);
* Have less than or equal to 3 bleeding sites and with all pockets less than or equal to 3mm deep (healthy test subjects only);
* Agree to fast 12 hours prior to any visit with a blood collection;
* Agree to not perform any oral hygiene for at least 12 hours prior to any visit with dental exams, saliva collection, and plaque collections;
* Agree to refrain from eating or drinking, using medicated lozenges, breaths mints, and chewing gum at least 4 hours prior to this study visit (exception allowed: small sips of water up until 45 minutes prior to their appointment) for any visit with plaque collections;
* Agree to refrain from use of any non-study oral hygiene products after the Product Distribution visit;
* Agree to continue their current oral hygiene products and habits until the Product Distribution visit;
* Agree to delay any elective dentistry, including dental prophylaxis outside of the study protocol, until the completion of the study;
* Agree to all study restrictions for the duration of the study (medicines/supplements/vaccines- see restricted list);
* Agree not to participate in any other oral care studies for the duration of this study;
* Agree to return for all scheduled visits and to follow all study procedures; and
* Be in good general health, as determined by the Investigator/Designee based on a review of their health history.

Exclusion Criteria:

* Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
* Active treatment for gingivitis, periodontitis, or caries;
* Daily use of NSAID;
* Having any of the following: fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers; removable partial dentures, peri/oral piercings, a pacemaker or other implanted device, unless deemed acceptable by the Investigator/Designee;
* A condition requiring the need for antibiotic premedication prior to dental procedures;
* Use of anti-inflammatory or anti-coagulant medications within 2 weeks of the Baseline visit, unless deemed acceptable by the Investigator/Designee;
* Having had oral/gum surgery within the previous 2 months;
* Smoking or vaping (regardless of content), use of smokeless tobacco, e-cigarettes, or nicotine patches);
* Currently using recreational drugs;
* Having been diagnosed with cardiovascular disease, diabetes (having an A1C ≥ 7), rheumatoid arthritis, liver disease, IBS, Crohn's Disease, Chronic Kidney Disease, or any type of autoimmune disease;
* Having any gastrointestinal issues (e.g. diarrhea, vomiting) in the past week;
* Use of statins or cholesterol lowering medication or supplements (e.g., Flax seeds, omega-3 fatty acids, Magnesium Oxide ≥250mg, Zyflamed, supplements containing berberine, golden thread, turmeric, CoQ10, or quercetin) for the duration of the study;
* Use of antibiotics or having a dental prophylaxis in the last 4 weeks prior the baseline visit, unless deemed acceptable by the Investigator/Designee;
* Receiving a flu shot or other vaccination in the last 4 weeks prior the baseline visit;
* Inability to undergo any study procedures;
* Currently undergoing treatment with GLP-1s antagonist;
* Nursing, self-reported pregnancy or the intention of becoming pregnant any time during the course of this study; or
* Having any condition or disease, as determined by the Investigator/Designee based on a review of the medical history which could be expected to interfere with examination procedures or with the subject's safe completion of the study.

Where this trial is running

Fort Wayne, Indiana and 1 other locations

• Salus Research — Fort Wayne, Indiana, United States (Not_yet_recruiting)
• Salus Research — Fort Wayne, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: Salus Research — Salus Research
• Study coordinator: Clinical Trial Manager

Conditions Gingivitis