Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-07 @ 8:56 PM
Study NCT ID:
NCT02543060
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2015-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate a Method for Plaque When Comparing Stannous Fluoride Toothpaste to a Regular Dentifrice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'C546060', 'term': 'hydrated silica gel-based toothpaste'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2015-09-04', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plaque scores', 'timeFrame': 'baseline'}, {'measure': 'plaque scores', 'timeFrame': 'week 8'}], 'secondaryOutcomes': [{'measure': 'gingivitis score', 'timeFrame': 'baseline'}, {'measure': 'gingivitis score', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque', 'Gingivitis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the sensitivity of an assay and its ability to split a marketed stannous fluoride toothpaste versus a negative control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nIn order to be included in the study, each subject must:\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 maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time;\n* Agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss or whitening products;\n* Agree to return for all scheduled visits and follow study procedures;\n* Must have at least 16 natural teeth;\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* Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;\n* Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;\n* Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);\n* Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm;\n* Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm.\n\nExclusion Criteria:\n\nSubjects are excluded from study participation where there is evidence of:\n\n* Have had a dental prophylaxis within 2 weeks of plaque sampling visits;\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, or advanced periodontitis requiring prompt treatment;\n* Need an antibiotic prophylaxis prior to dental visits;\n* A history of hypersensitivity to oral care products containing hydrogen peroxide;\n* A history of hypersensitivity to dyes (from products containing food dyes);\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; or\n* Are pregnant (Self-reported) or lactating."}, 'identificationModule': {'nctId': 'NCT02543060', 'briefTitle': 'A Pilot Study to Evaluate a Method for Plaque When Comparing Stannous Fluoride Toothpaste to a Regular Dentifrice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity When Comparing Two-step Toothpaste to a Regular Dentifrice', 'orgStudyIdInfo': {'id': '2015062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stannous fluoride toothpaste', 'description': 'brush twice a day for 8 weeks', 'interventionNames': ['Drug: stannous fluoride toothpaste']}, {'type': 'SHAM_COMPARATOR', 'label': 'cavity protection toothpaste', 'description': 'brush twice a day for 8 weeks', 'interventionNames': ['Drug: cavity protection toothpaste']}], 'interventions': [{'name': 'stannous fluoride toothpaste', 'type': 'DRUG', 'description': '0.454% stannous fluoride toothpaste', 'armGroupLabels': ['stannous fluoride toothpaste']}, {'name': 'cavity protection toothpaste', 'type': 'DRUG', 'description': '0.243% sodium fluoride toothpaste', 'armGroupLabels': ['cavity protection toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Salus Research', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}