Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-01-25 @ 3:58 AM
Study NCT ID:
NCT07211061
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2025-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002594', 'term': 'Cetylpyridinium'}], 'ancestors': [{'id': 'D011726', 'term': 'Pyridinium Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2011-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding (GBI)', 'timeFrame': 'Week 1, Week 3, and Week 6', 'description': 'Gingival Bleeding Index- evaluation of bleeding from gingival tissue, score from 0-2'}], 'secondaryOutcomes': [{'measure': 'Inflammation (MGI)', 'timeFrame': 'Week 1, Week 3, and Week 6', 'description': 'Modified Gingival Index- evaluation of the level of gingival tissue inflammation, scores from 0-4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for 6 weeks. The negative control group will be asked to brush 2x a day using a manual toothbrush in their customary manner for 6 weeks. Oral Soft Tissue (OST) assessments, gingivitis and plaque measurements will be taken at 4 time-points: Baseline (BL); Week 1; Week 3; and Week 6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provide written informed consent to participate in the study;\n* Be 18 years of age or older;\n* Agree not to participate in any other oral/dental product studies during the course of this study;\n* Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;\n* Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;\n* Have a Baseline MGI score of at least 1.75 but not greater than 2.3;\n* Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);\n* Agree to return for all scheduled visits and follow study procedures;\n* Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.\n\nExclusion Criteria:\n\n* Have had a dental prophylaxis within 2 weeks of Baseline visit;\n* Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;\n* Have rampant caries, open or untreated caries, severe gingivitis, or advanced periodontitis requiring prompt treatment; or,\n* Need an antibiotic prophylaxis prior to dental visits,\n* Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study,\n* Are pregnant (Self-reported) or lactating."}, 'identificationModule': {'nctId': 'NCT07211061', 'briefTitle': 'A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'A SIX WEEK CLINICAL STUDY TO EVALUATE THE EFFECT OF A REGIMEN ON GINGIVITIS', 'orgStudyIdInfo': {'id': '2011068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Hygiene Regimen', 'description': 'toothpaste, electric toothbrush, and mouth rinse', 'interventionNames': ['Drug: Stannous Fluoride Dentifrice', 'Device: electric toothbrush', 'Drug: Cetylpyridinium Chloride (CPC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Negative Control', 'description': 'toothpaste and manual toothbrush', 'interventionNames': ['Drug: Sodium Fluoride Dentifrice', 'Device: manual toothbrush']}], 'interventions': [{'name': 'Stannous Fluoride Dentifrice', 'type': 'DRUG', 'description': 'brush 2x a day in using a power brush (2 minutes of brushing)', 'armGroupLabels': ['Oral Hygiene Regimen']}, {'name': 'Sodium Fluoride Dentifrice', 'type': 'DRUG', 'description': 'brush in their customary manner', 'armGroupLabels': ['Negative Control']}, {'name': 'electric toothbrush', 'type': 'DEVICE', 'description': 'brush using a electric brush (2 minutes of brushing)', 'armGroupLabels': ['Oral Hygiene Regimen']}, {'name': 'Cetylpyridinium Chloride (CPC)', 'type': 'DRUG', 'description': 'use 20 ml of mouth rinse for 30 seconds', 'armGroupLabels': ['Oral Hygiene Regimen']}, {'name': 'manual toothbrush', 'type': 'DEVICE', 'description': 'brush in their customary manner', 'armGroupLabels': ['Negative Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Bio-Sci Research (Out of Business)', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}