Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-27 @ 4:39 AM
Study NCT ID:
NCT03426150
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2018-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Casein Phosphopeptide--amorphous Calcium Phosphate on Human Enamel Subjected to in Vivo Acid Attacks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014077', 'term': 'Tooth Erosion'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D057085', 'term': 'Tooth Wear'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C447032', 'term': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface microhardness', 'timeFrame': 'baseline', 'description': 'a Vickers microhardness tester with microscopic lens was used, with a 100 g load and 30-s dwell time. Three microhardness measurements were obtained on the top surface of each specimen.'}, {'measure': 'Surface microhardness', 'timeFrame': '7 days', 'description': 'a Vickers microhardness tester with microscopic lens was used, with a 100 g load and 30-s dwell time. Three microhardness measurements were obtained on the top surface of each specimen.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Erosion']}, 'referencesModule': {'references': [{'pmid': '29857075', 'type': 'DERIVED', 'citation': 'Yu H, Jiang NW, Ye XY, Zheng HY, Attin T, Cheng H. In situ effect of Tooth Mousse containing CPP-ACP on human enamel subjected to in vivo acid attacks. J Dent. 2018 Sep;76:40-45. doi: 10.1016/j.jdent.2018.05.021. Epub 2018 May 30.'}]}, 'descriptionModule': {'briefSummary': '40 specimens were prepared from fresh-extracted human molars and further embedded using the acrylic resin. Specimens were randomly divided into 2 groups according to the treatment before in vivo erosion (n=20): CPP-ACP for 3 min (CPP-ACP group) and deionized water for 3 min (control group). 10 healthy volunteers were recruited and customized maxillary appliance containing 4 specimens (2 from CPP-ACP group and 2 from control group) was fabricated for each volunteer. Participants were instructed to drink 150 ml cola in 5 min using the gargling method after placing appliances intraorally for 2 h. The in vivo attacks were performed 4 X 5 min with 1-h interval daily over 7 d. The surface microhardness and surface microstructure of the specimens were evaluated at the baseline and after the treatment. The data were statistically analyzed using three-way ANOVA and post hoc tests. Data were considered statistically significant at a level of P \\<0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 60 years of age and in good general health\n* Dental erosion and wear degree is 0-1\n\nExclusion Criteria:\n\n* Systemic diseases or oral mucosal disorders\n* Current orthodontic treatment\n* Pregnancy\n* Known allergies to the experimental drink\n* Had been given drugs which lead to dry oral more regularly within half a year'}, 'identificationModule': {'nctId': 'NCT03426150', 'briefTitle': 'Casein Phosphopeptide--amorphous Calcium Phosphate on Human Enamel Subjected to in Vivo Acid Attacks', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'In Situ Effect of Casein Phosphopeptide--amorphous Calcium Phosphate on the Surface Microhardness of Human Enamel Subjected to in Vivo Acid Attacks', 'orgStudyIdInfo': {'id': '20151225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPP-ACP', 'description': 'Tooth mousse (GC, Japan) application on the specimen surface for 3 min.', 'interventionNames': ['Drug: CPP-ACP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Deionized water', 'description': 'Deionized water application on the specimen surface for 3 min', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'CPP-ACP', 'type': 'DRUG', 'description': 'The surfaces of specimens were pretreated with CPP-ACP for 3 min', 'armGroupLabels': ['CPP-ACP']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'The surfaces of specimens were pretreated with deionized water for 3 min', 'armGroupLabels': ['Deionized water']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hao Yu, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School and Hospital of Stomatology, Fujian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Head', 'investigatorFullName': 'Hao Yu', 'investigatorAffiliation': 'Fujian Medical University'}}}}