> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluating-gingivitis-and-systemic-biomarkers-1fb281f4-bebb-4506-bcd9-470012dbd43c > Record changed: 2026-11-04 # Evaluating Gingivitis and Systemic Biomarkers NCT06962956 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) Participants 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) Lead sponsor Procter and Gamble Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) Start date 2025-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Short title** Evaluating Gingivitis and Systemic Biomarkers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Official title** An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Dates **Completion date** 2025-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **First posted** 2025-05-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Registry last updated** 2025-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Primary completion date** 2025-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Start date** 2025-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Size and sites **Participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Planned participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Lead sponsor** Procter and Gamble Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Identifiers **Registry ID** NCT06962956 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **ClinicalTrials.gov ID** NCT06962956 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** Double masking **Masked roles** Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Outcomes ### Primary outcomes 1. Number Bleeding Sites Timeframe: 4 months Total number of bleeding sites Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 25 Years **Maximum age** 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Sites - Salus ResearchFort Wayne, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06962956) ## Related records ### Drugs (2) - [Sodium monofluorophosphate](https://trialight.com/data/asset/sodium-monofluorophosphate-9c35619e-72d7-4153-9ef4-f491755ee3e9.md) - [Stannous fluoride](https://trialight.com/data/asset/stannous-fluoride-eb49d118-dc3f-4633-a9d1-c037ee5b5c77.md) ### Lead sponsors (1) - [Procter and Gamble](https://trialight.com/data/company/procter-and-gamble-0129c305-d446-4274-ad81-a18c6a680f6b.md) ### Conditions (1) - [Gingivitis](https://trialight.com/data/condition/gingivitis-82582680-34f0-54d2-abbe-433510e71aaa.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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