Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT00670618
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2008-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2011-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2008-04-30', 'studyFirstSubmitQcDate': '2008-05-01', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of the opacity of white spots during orthodontic treatment with fixed appliances', 'timeFrame': 'After 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Early Caries Lesions']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No white spot lesion at the time of placement of fixed appliances\n\nExclusion Criteria:\n\n* White spots already present before start orthodontic treatment'}, 'identificationModule': {'nctId': 'NCT00670618', 'briefTitle': 'A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2', 'orgStudyIdInfo': {'id': '2008/187 - Part 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'CPP-ACP (GC Tooth Mousse)', 'interventionNames': ['Device: CPP-ACP (GC Tooth Mousse)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'GCC-ACP (GC MI Paste Plus)', 'interventionNames': ['Device: CPP-ACP (GC MI Paste Plus)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Fluoride (Elmex Medical Gel)', 'interventionNames': ['Device: Fluoride (Elmex Medical Gel)']}, {'type': 'NO_INTERVENTION', 'label': '4', 'description': 'Control group'}], 'interventions': [{'name': 'CPP-ACP (GC Tooth Mousse)', 'type': 'DEVICE', 'description': 'Calcium and phosphate', 'armGroupLabels': ['1']}, {'name': 'CPP-ACP (GC MI Paste Plus)', 'type': 'DEVICE', 'description': 'Calcium, phosphate and fluoride', 'armGroupLabels': ['2']}, {'name': 'Fluoride (Elmex Medical Gel)', 'type': 'DEVICE', 'description': 'Fluoride', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Guy De Pauw, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'GC Europe', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}