Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 10:16 PM
Study NCT ID:
NCT07124533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D003258', 'term': 'Consumer Behavior'}], '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'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014100', 'term': 'Toothpastes'}], 'ancestors': [{'id': 'D003802', 'term': 'Dentifrices'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Index Score at Baseline', 'timeFrame': 'Change between baseline at visit 1 and visit 2, six weeks post baseline', 'description': 'The quantity of plaque build-up is measured visually using the Quigley-Hein Plaque Index. The Plaque index can range from 0 to 5, with higher numbers indicating more plaque build-up.'}, {'measure': 'Gingival Index Score at Baseline', 'timeFrame': 'Change between baseline at visit 1 and visit 2, six weeks post baseline', 'description': 'The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation.'}], 'secondaryOutcomes': [{'measure': 'DMFT Score at Baseline', 'timeFrame': 'Change between baseline at visit 1 and visit 2, six weeks post baseline', 'description': 'Caries experiences is measured visually using the DMFT index. DMFT score can range from 0 to 28, with higher numbers indicating higher caries experiences.'}, {'measure': 'Subject Perception of Product Use', 'timeFrame': 'Visit 2 six weeks post study enrollment', 'description': 'The perception on the product usage is measured using a survey containing questions on feel, texture, flavor, ease of use, eco-friendliness, cost and overall satisfaction. Response is on a 4 point Likert scale ranging from strongly agree (1) to strongly disagree (4).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival Index', 'Plaque Index', 'Dentifrice', 'Toothpaste Tablets', 'Caries Experiences', 'Consumer Satisfaction'], 'conditions': ['Gingival Inflammation', 'Dental Caries']}, 'descriptionModule': {'briefSummary': "Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque.\n\nMethods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects are 18 years or older;\n2. Subjects who will comply with study protocol;\n3. Subjects who can read and understand the consent form;\n4. Subjects available during the study period;\n5. Subjects have more than 20 teeth.\n\nExclusion Criteria:\n\n1\\. Subjects under the age of 18.'}, 'identificationModule': {'nctId': 'NCT07124533', 'briefTitle': 'Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences: A 6-week Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '5250357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toothpaste Tablet', 'description': 'Subjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes.', 'interventionNames': ['Drug: Toothpaste Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Toothpaste', 'description': 'Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes.', 'interventionNames': ['Drug: Conventional Toothpaste']}], 'interventions': [{'name': 'Toothpaste Tablet', 'type': 'DRUG', 'otherNames': ['Denttabs Toothpaste Tablets'], 'description': 'Denttabs toothpaste tablets', 'armGroupLabels': ['Toothpaste Tablet']}, {'name': 'Conventional Toothpaste', 'type': 'DRUG', 'otherNames': ['Colgate Cavity Protection'], 'description': 'Colgate Cavity Protection toothpaste', 'armGroupLabels': ['Conventional Toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Health', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'centralContacts': [{'name': 'So Ran Kwon, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'sorankwon@llu.edu', 'phone': '909 558 5118', 'phoneExt': '55118'}], 'overallOfficials': [{'name': 'So Ran Kwon, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}