evaluating gingivitis and systemic biomarkers

Conditions: Gingivitis

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.


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.