Gingivitis
Conditions
Brief summary
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.
Interventions
Brush two times a day for 1 minute with manual toothbrush
Brush two times a day for 1 minute with manual toothbrush
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Bleeding Sites | 4 months | Total number of bleeding sites |
Countries
United States
Outcome results
None listed