Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT01377493
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2011-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Chewing Gum Containing POs-Ca and Fluoride on Enamel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002638', 'term': 'Chewing Gum'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-20', 'studyFirstSubmitDate': '2011-06-17', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mineral content of enamel', 'timeFrame': '2 weeks', 'description': 'Mineral content of bovine enamel blocks inserted into the subject mouth during chewing of the gums was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chewing-gum', 'enamel subsurface lesion', 'calcium additives', 'fluoride', 'in situ'], 'conditions': ['Enamel Subsurface Lesion']}, 'referencesModule': {'references': [{'pmid': '22337700', 'type': 'DERIVED', 'citation': 'Kitasako Y, Sadr A, Hamba H, Ikeda M, Tagami J. Gum containing calcium fluoride reinforces enamel subsurface lesions in situ. J Dent Res. 2012 Apr;91(4):370-5. doi: 10.1177/0022034512439716. Epub 2012 Feb 15.'}, {'pmid': '21875640', 'type': 'DERIVED', 'citation': 'Kitasako Y, Tanaka M, Sadr A, Hamba H, Ikeda M, Tagami J. Effects of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization and crystallization of enamel subsurface lesions in situ. J Dent. 2011 Nov;39(11):771-9. doi: 10.1016/j.jdent.2011.08.009. Epub 2011 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '31 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adult subjects\n* More than 22 permanent teeth\n\nExclusion Criteria:\n\n* Alcohol addiction\n* Smoking\n* Active caries\n* Periodontal pockets\n* Low-saliva flow (less than 0.3ml/min)'}, 'identificationModule': {'nctId': 'NCT01377493', 'briefTitle': 'Effects of a Chewing Gum Containing POs-Ca and Fluoride on Enamel', 'organization': {'class': 'OTHER', 'fullName': 'Tokyo Medical and Dental University'}, 'officialTitle': 'Effects of a Chewing Gum Containing POs-Ca and Fluoride on Remineralization of Enamel Subsurface Lesions in Situ', 'orgStudyIdInfo': {'id': '1B116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: chewing gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'POs-Ca', 'interventionNames': ['Dietary Supplement: chewing gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'POs-Ca+F', 'interventionNames': ['Dietary Supplement: chewing gum']}], 'interventions': [{'name': 'chewing gum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions', 'armGroupLabels': ['POs-Ca', 'POs-Ca+F', 'placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokyo Medical and Dental University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yuichi Kitasako', 'oldOrganization': 'Tokyo Medical and Dental University'}}}}