Evaluating Gingivitis and Systemic Biomarkers
NCT06962956
Phase
Phase 1
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Procter and Gamble
Start date
2025-04-30
Number of sites
- 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.
- Short title
- Evaluating Gingivitis and Systemic Biomarkers
- Official title
- An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-10-31
- First posted
- 2025-05-08
- Registry last updated
- 2025-06-03
- Primary completion date
- 2025-10-31
- Start date
- 2025-04-30
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Procter and Gamble
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06962956
- ClinicalTrials.gov ID
- NCT06962956
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- Double masking
- Masked roles
- Investigators, Outcome assessors
Sources for study design
Number Bleeding Sites
Timeframe: 4 months
Total number of bleeding sites
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 25 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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.
- 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
- Salus ResearchFort Wayne, United States
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Gingivitis Primary condition