ACTIVE_NOT_RECRUITING

Evaluating Gingivitis and Systemic Biomarkers

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers

Quick Facts

Study Start:2025-04-30

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06962956

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Salus Research

PRINCIPAL_INVESTIGATOR

Salus Research

Study Locations (Sites)

Salus Research

Fort Wayne, Indiana, 46825

United States

Collaborators and Investigators

Sponsor: Procter and Gamble

Salus Research, PRINCIPAL_INVESTIGATOR, Salus Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2025-04-30

Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

Gingivitis