Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT06892834
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number Bleeding Sites', 'timeFrame': '1 month and 3 months'}], 'secondaryOutcomes': [{'measure': 'Löe-Silness Gingivitis Evaluation', 'timeFrame': '1 month and 3 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effect of two experimental hops extract-containing dentifrices on gingivitis relative to a positive control 0.454% SnF2 dentifrice and a negative control dentifrice after 12 weeks of product use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years of age;\n* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;\n* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; If female of child-bearing potential, agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of medically approved birth control include: at least 3 months of use of a hormonal birth control (including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant), double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening. Not applicable to females not of child-bearing potential (females who have undergone a sterilization procedure including hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior;\n* If female and of child-bearing potential, agree to immediately inform the study investigator if they become pregnant;\n* Have at least 20 gradable teeth;\n* Have mild to moderate gingivitis with a range of 10 to 70% bleeding sites;\n* Agree to return for scheduled visits and follow the study procedures;\n* Agree to refrain from use of any non-study oral hygiene products for the duration of the study; regular floss users can continue to floss in their customary manner.\n* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; and\n* Agree to refrain from any oral hygiene the morning of each visit.\n\nExclusion Criteria:\n\n* Having taken antibiotic, anti-inflammatory, or anticoagulant medications within 4 weeks of the baseline visit;\n* Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, severe gingivitis, or advanced periodontal disease;\n* Females of child-bearing potential who are not using a medically approved method of birth control (i.e., hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening) or who have not been using hormonal birth control for a minimum of 3 months prior to study enrollment;\n* Taking medication that alters gingival appearance or gingival bleeding (e.g., calcium channel blockers, anticonvulsants, or immunosuppressants) within one month prior to study initiation;\n* Regularly (\\>5x/week) using anti-gingivitis treatments (e.g., stannous fluoride toothpaste, or anti-gingivitis mouthwashes, such as those containing chlorohexidine) in the month prior to screening;\n* Removable oral appliances;\n* Fixed facial or lingual orthodontic appliances;\n* Have a positive pregnancy test (Clearblue) at baseline or self-reported pregnancy during the study; ;\n* Any diseases or condition that might interfere with the safe participation in the study according to the study investigator;\n* Inability to undergo study procedures; and\n* Allergic reactions to any of the study toothpastes and/or ingredients in the study toothpastes.'}, 'identificationModule': {'nctId': 'NCT06892834', 'briefTitle': 'Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'A Three-month Clinical Study to Assess the Gingivitis Effect of Various Dentifrices.', 'orgStudyIdInfo': {'id': '2024026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Positive Control', 'description': '0.454% stannous fluoride, 0.533% zinc citrate', 'interventionNames': ['Drug: Stannous Fluoride Dentifrice']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental #1', 'description': '0.243% NaF with 0.1% Hops, Humulus lupulus extract \\[0.045% hops β-acids\\]', 'interventionNames': ['Drug: Sodium Fluoride Dentifrice']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental #2', 'description': '0.243% NaF with 0.5% Hops, Humulus lupulus extract \\[0.225% hops β-acids\\]', 'interventionNames': ['Drug: Sodium Fluoride Dentifrice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Negative Control', 'description': '0.76% Sodium Monofluorophosphate', 'interventionNames': ['Drug: Sodium monofluorophosphate dentifrice']}], 'interventions': [{'name': 'Stannous Fluoride Dentifrice', 'type': 'DRUG', 'description': 'Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.', 'armGroupLabels': ['Positive Control']}, {'name': 'Sodium Fluoride Dentifrice', 'type': 'DRUG', 'description': 'Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.', 'armGroupLabels': ['Experimental #1', 'Experimental #2']}, {'name': 'Sodium monofluorophosphate dentifrice', 'type': 'DRUG', 'description': 'Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.', 'armGroupLabels': ['Negative Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L5N 6J2', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'All Sum ResearchAll Sum Research Center Ltd.', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'All Sum Research', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'All Sum Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}