Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-29 @ 1:34 AM
Study NCT ID:
NCT01733420
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2012-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biodentine Versus White MTA Pulpotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2012-11-07', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical successes after pulpotomy.', 'timeFrame': 'at baseline visit', 'description': 'clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.'}, {'measure': 'Clinical success after pulpotomy.', 'timeFrame': '3 months after pulpotomy.', 'description': 'clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.'}, {'measure': 'Clinical successes after pulpotomy.', 'timeFrame': '6 months after pulpotomy.', 'description': 'Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.'}, {'measure': 'Clinical successes after pulpotomy.', 'timeFrame': '12 months after pulpotomy.', 'description': 'Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.'}, {'measure': 'Radiographic successes after pulpotomy.', 'timeFrame': 'at baseline visit', 'description': 'Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.'}, {'measure': 'Radiographic successes after pulpotomy.', 'timeFrame': '6 months after pulpotomy.', 'description': 'Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.'}, {'measure': 'Radiographic successes after pulpotomy.', 'timeFrame': '12 months after pulpotomy.', 'description': 'Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Extensive Decay in Primary Molars']}, 'descriptionModule': {'briefSummary': 'A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.\n\nNull Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.\n* Patients without any known medical history of systemic complications contradicting pulp treatment.\n* Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.\n* Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes."}, 'identificationModule': {'nctId': 'NCT01733420', 'briefTitle': 'Biodentine Versus White MTA Pulpotomy', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial', 'orgStudyIdInfo': {'id': '2011/538'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biodentine', 'description': 'Pulpotomy using Biodentine as pulpotomy medicine.', 'interventionNames': ['Drug: Biodentine pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'White Mineral trioxide Aggregate (MTA)', 'description': 'Pulpotomy using white MTA as pulpotomy medicine.', 'interventionNames': ['Drug: White MTA pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tempophore', 'description': 'Pulpotomy using Tempophore as pulpotomy medicine in a control group.', 'interventionNames': ['Drug: Tempophore pulpotomy']}], 'interventions': [{'name': 'Biodentine pulpotomy', 'type': 'DRUG', 'armGroupLabels': ['Biodentine']}, {'name': 'White MTA pulpotomy', 'type': 'DRUG', 'armGroupLabels': ['White Mineral trioxide Aggregate (MTA)']}, {'name': 'Tempophore pulpotomy', 'type': 'DRUG', 'armGroupLabels': ['Tempophore']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Luc Martens, PhD, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}