Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT04303767
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2020-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C447032', 'term': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'id': 'D057087', 'term': 'Dental Atraumatic Restorative Treatment'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-07', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-07', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate and compare the clinical outcome of Atraumatic Restorative Treatment with and without Casein Phosphopeptide Amorphous Calcium Phosphate varnish placed on caries affected dentine in primary molars to evaluate the restoration success or failure.', 'timeFrame': '12 months', 'description': 'clinical criteria and ART success criteria will be assessed'}, {'measure': 'Assess the radiographic success of Atraumatic Restorative Treatment with and without CPP-ACP varnish placed on caries affected dentine in primary molars by measuring the grey value radiographically using Image J software.', 'timeFrame': '12 months', 'description': 'radiographic success of the teeth and radiographic density measures will be assessed'}, {'measure': 'Assess histologically the quality of the formed dentine using the Polarized Light Microscope and Scanning Electron Microscope.', 'timeFrame': 'throughout the 12 months', 'description': 'polarized light microscope and scanning electron microscope will be used to describe the repaired dentine and the bacterial load'}], 'primaryOutcomes': [{'measure': 'Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars.', 'timeFrame': '12 months', 'description': 'this is by evaluating the clinical and radiographic data and also by descriptive histological assessment'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Casein Phosphopeptide Amorphous Calcium Phosphate', 'CPP-ACP', 'caries affected dentine', 'dentine repair', 'Atraumatic Restorative Treatment'], 'conditions': ['Caries,Dental']}, 'descriptionModule': {'briefSummary': 'Teeth selected for intervention with Atraumatic Restorative Treatment will receive Glass Ionomer restorations (control) or MI varnish (test) before receiving the Glass Ionomer restoration', 'detailedDescription': 'Patients selected to participate in the study will be randomly assigned into 2 groups.\n\nGroup 1 (test): who will receive casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) + ART in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.\n\nGroup 2 (control): Who will receive ART only in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy patients.\n2. Patients with an age range of 6-8 years old for clinical evaluation.\n3. Patients ranking definitely positive or positive on Frankl scale.\n4. Patients having at least 1 symptomless primary molar with caries extending to the dentine (International Caries Detection and Assessment System (ICDAS II) code 4, 5 \\& 6).\n5. The presence of the permanent successors when examined by periapical X-ray.\n6. Patients who will agree to participate in the study. For the ex-vivo sample\n\n 1. Patients with an age range of 9-11 years old.\n 2. The selected teeth should have more than half of their roots physiologically resorbed when examined by periapical X-ray.\n\nExclusion Criteria:\n\n1. Patients with special health care needs (physical, mental or medical).\n2. Primary molars that are mobile, ankylosed or have periapical pathology on initial examination clinically and radiographically.'}, 'identificationModule': {'nctId': 'NCT04303767', 'briefTitle': 'The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Reparative Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Varnish on Caries Affected Dentine in Primary Teeth (Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '00010556-IORG0008839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test (ART + CPP-ACP)', 'description': 'In this group, teeth selected will receive intervention with CPP-ACP and restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART', 'interventionNames': ['Drug: Casein phosphopeptide amorphous calcium phosphate', 'Procedure: Atraumatic restorative treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control (ART)', 'description': 'in this group, teeth selected will receive restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART', 'interventionNames': ['Procedure: Atraumatic restorative treatment']}], 'interventions': [{'name': 'Casein phosphopeptide amorphous calcium phosphate', 'type': 'DRUG', 'otherNames': ['MI varnish'], 'description': 'varnish containing calcium and phospate ions which act as a source for tooth remineralization', 'armGroupLabels': ['Test (ART + CPP-ACP)']}, {'name': 'Atraumatic restorative treatment', 'type': 'PROCEDURE', 'otherNames': ['ART'], 'description': 'excavation of dental caries and restoring with light cured Glass Ionomer Restoration', 'armGroupLabels': ['Control (ART)', 'Test (ART + CPP-ACP)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Mohamed A. Bayoumi, MSc', 'role': 'CONTACT', 'email': 'mohamed.bayoumi@pua.edu.eg', 'phone': '0122273853'}], 'overallOfficials': [{'name': 'Mohamed A. Bayoumi, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharos University in Alexandria'}, {'name': 'Azza G. Hanno, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Karin M. Dowidar, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Samia S. Omar, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}