Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-24 @ 12:40 PM
Study NCT ID:
NCT02298504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2014-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vital Pulp Treatment in Primary Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C086631', 'term': 'mineral trioxide aggregate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success after pulpotomy', 'timeFrame': '3 years', 'description': 'No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth'}, {'measure': 'Clinical success after indirect pulp cap', 'timeFrame': '3 years', 'description': 'No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth'}, {'measure': 'Radiographic success after pulpotomy', 'timeFrame': '3 years', 'description': 'No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, presence of normal appearance of periodontal ligament space'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Vital Pulp Therapies', 'Indirect Pulp Cap', 'Pulpotomy']}, 'descriptionModule': {'briefSummary': "In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.", 'detailedDescription': 'Pediatric patients having deep decay in primary molars seen at UMMC, UMSOD, and University of Maryland Rehabilitation and Orthopaedic Institute, will be included in the sample. Teeth with deep caries, \\>50% into dentin, will be randomly assigned using a table of random numbers to the three treatment groups:\n\nGroup 1 pulpotomy with MTA, Group 2 pulpotomy with Biodentine, Group 3 indirect pulp treatment. Treatment will be performed by board certified pediatric dentists or they will directly supervise pediatric dental residents at each site as part of their regular protocol for treating deep caries.\n\nRadiographs will be taken as prescribed in the Guideline for taking Radiographs in Children by the American Academy of Pediatric Dentistry.\n\nTwice yearly clinical examinations will be performed by the treating dentists or pediatric dental residents to check for any soft tissue pathology such as abscess or mobility of treated tooth/teeth. If treatment success/failure consensus between the blinded dentists is not reached, a third dentist will be consulted.\n\nThe success/failure data will be entered onto spreadsheets and examined statistically using statistical software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients with deep dental decay in primary molars\n* Teeth with signs and symptoms of reversible pulpitis\n\nExclusion Criteria:\n\n* Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection\n* Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease\n* Teeth that are not restorable'}, 'identificationModule': {'nctId': 'NCT02298504', 'briefTitle': 'Vital Pulp Treatment in Primary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth', 'orgStudyIdInfo': {'id': 'HP-00058711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indirect pulp cap', 'description': 'IDP will be performed for this group', 'interventionNames': ['Device: Vitrebond']}, {'type': 'EXPERIMENTAL', 'label': 'MTA pulpotomy', 'description': 'MTA pulpotomy will be performed for this group', 'interventionNames': ['Drug: Mineral Trioxide Aggregate']}, {'type': 'EXPERIMENTAL', 'label': 'Biodentin pulpotomy', 'description': 'Biodentin pulpotomy will be performed for this group', 'interventionNames': ['Drug: Biodentin']}], 'interventions': [{'name': 'Mineral Trioxide Aggregate', 'type': 'DRUG', 'otherNames': ['MTA pulpotomy'], 'description': 'Vital pulp therapy', 'armGroupLabels': ['MTA pulpotomy']}, {'name': 'Biodentin', 'type': 'DRUG', 'otherNames': ['Biodentin Pulpotomy'], 'description': 'Vital pulp therapy', 'armGroupLabels': ['Biodentin pulpotomy']}, {'name': 'Vitrebond', 'type': 'DEVICE', 'otherNames': ['Indirect pulp cap'], 'description': 'Vital pulp therapy', 'armGroupLabels': ['Indirect pulp cap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21043', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Dentistry', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Graduate Program Director', 'investigatorFullName': 'Vineet Dhar', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}