Evaluating Gingivitis and Systemic Biomarkers

Procter & Gamble (P&G)

Status and phase: Enrolling; Phase 1

Conditions: Gingivitis

Treatments: Drug: 0.454% Stannous Fluoride Dentifrice; Drug: 0.76% Sodium Monofluorophosphate Dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT06962956

2024058

Details and patient eligibility

About

This exploratory study will consist of two parts: Phase 1 (sample collection/screening) and Phase 2 (sample collection/product efficacy testing). The purpose of Phase 1 is to understand the association of gingivitis to systemic biomarkers and to screen subjects for Phase 2. The purpose of Phase 2 is to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers.

Enrollment: 135 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 3 patient groups

Negative Control

Active Comparator group

Description:

0.76% sodium monofluorophosphate

Treatment:

Drug: 0.76% Sodium Monofluorophosphate Dentifrice

Test

Active Comparator group

Description:

0.454% stannous fluoride

Treatment:

Drug: 0.454% Stannous Fluoride Dentifrice

Drug: 0.454% Stannous Fluoride Dentifrice

Positive Control

Active Comparator group

Description:

0.454% stannous fluoride

Treatment:

Drug: 0.454% Stannous Fluoride Dentifrice

Drug: 0.454% Stannous Fluoride Dentifrice