Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 11:46 AM
Study NCT ID:
NCT06962956
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Gingivitis and Systemic Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number Bleeding Sites', 'timeFrame': '4 months', 'description': 'Total number of bleeding sites'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provide informed consent and receive a signed copy of the informed consent form;\n* Be between 25 - 65 years of age;\n* Have at least 16 gradable teeth;\n* 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);\n* Have less than or equal to 3 bleeding sites and with all pockets less than or equal to 3mm deep (healthy test subjects only);\n* Agree to fast 12 hours prior to any visit with a blood collection;\n* Agree to not perform any oral hygiene for at least 12 hours prior to any visit with dental exams, saliva collection, and plaque collections;\n* 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;\n* Agree to refrain from use of any non-study oral hygiene products after the Product Distribution visit;\n* Agree to continue their current oral hygiene products and habits until the Product Distribution visit;\n* Agree to delay any elective dentistry, including dental prophylaxis outside of the study protocol, until the completion of the study;\n* Agree to all study restrictions for the duration of the study (medicines/supplements/vaccines- see restricted list);\n* Agree not to participate in any other oral care studies for the duration of this study;\n* Agree to return for all scheduled visits and to follow all study procedures; and\n* Be in good general health, as determined by the Investigator/Designee based on a review of their health history.\n\nExclusion Criteria:\n\n* Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;\n* Active treatment for gingivitis, periodontitis, or caries;\n* Daily use of NSAID;\n* 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;\n* A condition requiring the need for antibiotic premedication prior to dental procedures;\n* Use of anti-inflammatory or anti-coagulant medications within 2 weeks of the Baseline visit, unless deemed acceptable by the Investigator/Designee;\n* Having had oral/gum surgery within the previous 2 months;\n* Smoking or vaping (regardless of content), use of smokeless tobacco, e-cigarettes, or nicotine patches);\n* Currently using recreational drugs;\n* 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;\n* Having any gastrointestinal issues (e.g. diarrhea, vomiting) in the past week;\n* 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;\n* Use of antibiotics or having a dental prophylaxis in the last 4 weeks prior the baseline visit, unless deemed acceptable by the Investigator/Designee;\n* Receiving a flu shot or other vaccination in the last 4 weeks prior the baseline visit;\n* Inability to undergo any study procedures;\n* Currently undergoing treatment with GLP-1s antagonist;\n* Nursing, self-reported pregnancy or the intention of becoming pregnant any time during the course of this study; or\n* 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."}, 'identificationModule': {'nctId': 'NCT06962956', 'briefTitle': 'Evaluating Gingivitis and Systemic Biomarkers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers', 'orgStudyIdInfo': {'id': '2024058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Negative Control', 'description': '0.76% sodium monofluorophosphate', 'interventionNames': ['Drug: 0.76% Sodium Monofluorophosphate Dentifrice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test', 'description': '0.454% stannous fluoride', 'interventionNames': ['Drug: 0.454% Stannous Fluoride Dentifrice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive Control', 'description': '0.454% stannous fluoride', 'interventionNames': ['Drug: 0.454% Stannous Fluoride Dentifrice']}], 'interventions': [{'name': '0.76% Sodium Monofluorophosphate Dentifrice', 'type': 'DRUG', 'description': 'Brush two times a day for 1 minute with manual toothbrush', 'armGroupLabels': ['Negative Control']}, {'name': '0.454% Stannous Fluoride Dentifrice', 'type': 'DRUG', 'description': 'Brush two times a day for 1 minute with manual toothbrush', 'armGroupLabels': ['Test']}, {'name': '0.454% Stannous Fluoride Dentifrice', 'type': 'DRUG', 'description': 'Brush two times a day for 2 minutes with electric toothbrush', 'armGroupLabels': ['Positive Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Salus Research', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}], 'overallOfficials': [{'name': 'Salus Research', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salus Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}