Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-13 @ 1:27 PM
Study NCT ID:
NCT03838094
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2019-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2019-12-01', 'unreleaseDate': '2019-12-03'}, {'resetDate': '2019-12-20', 'releaseDate': '2019-12-03'}], 'estimatedResultsFirstSubmitDate': '2019-12-01'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C506393', 'term': 'tricalcium silicate'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'C086631', 'term': 'mineral trioxide aggregate'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-18', 'size': 393550, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-07T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-08', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain, sensitivity to percussion⁄ palpation', 'timeFrame': '18 months', 'description': 'by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure'}, {'measure': 'Swelling or sinus tract', 'timeFrame': '18 months', 'description': 'by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment'}, {'measure': 'tooth mobility', 'timeFrame': '18 months', 'description': 'by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment'}], 'secondaryOutcomes': [{'measure': 'root formation/development stage', 'timeFrame': '18 months', 'description': 'by radiographic parallel technique to measure the maturity scores used during the radiographic assessment of root development are F, G and H (where F is the worse and H is the best stage)'}, {'measure': 'Crown: Root ratio', 'timeFrame': '18 months', 'description': 'by radiographic parallel technique ( the ratio 2:1 or more than 2:1) the ratio more than 2:1 is the best'}, {'measure': 'Apical closure', 'timeFrame': '18 months', 'description': 'by radiographic parallel technique( the apex is blunder apex ,partially open, or constricted) blunder apex is the worse and constricted apex is the best.'}, {'measure': 'presence of radiolucency', 'timeFrame': '18 month', 'description': 'by radiographic parallel technique( binary measure)( yes or No) if radiolucency is detected this indicates failure of the treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulp exposure', 'vital immature', 'MTA', 'Biodentine'], 'conditions': ['Carious Exposure of Pulp']}, 'descriptionModule': {'briefSummary': 'Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) of cariously exposed vital immature mandibular first permanent molars.\n\nMaterials and Methods: sixty immature first mandibular permanent molars cariously exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Following split-mouth design molars were randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30 molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated molars received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analysed.', 'detailedDescription': "Diagnosis:\n\n1. Full history data will be collected, including personal, medical and previous dental data\n2. Clinical examination using mirror and probe to assess the inclusion criteria.\n3. Radiographic examination using preoperative digital periapical radiograph to assess the inclusion criteria.\n4. Preoperative photograph will be taken.\n\nOperative procedure:\n\nExperimental group:\n\n1. Injection of local anesthesia and rubber dam isolation.\n2. caries and roof of the pulp chamber will be removed by a fissure diamond bur (Diatech, Heerbrug, Switzerland) and high-speed handpiece with coolant.\n3. The pulps will be amputated to the orifice level using a long-shank diamond round bur.\n4. Haemostasis will be achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min.\n5. Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France) will be mixed according to the manufacturer's instructions, radicular pulp will be covered by the material using a wet cotton pellet.\n6. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.\n7. Immediate post-operative radiograph and photograph will be taken.\n\nControl group:\n\nThe same procedures will be carried out as the experimental group, but the pulp stumps will be covered with fast-setting mineral trioxide aggregate (MTA) ENDOCEM MTA (Maruchi, Wonju, Korea) and will be prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA will be placed over the amputated pulps and will be gently adapted to the dentinal walls using a wet cotton pellet. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.\n\nPostoperative care:\n\nInstructions to avoid lip and cheek biting in addition to oral hygiene measures.\n\nFollow up:\n\nAssess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 months)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilaterally Symptomatic ⁄ asymptomatic vital immature mandibular first permanent molars (with clinical carious exposure of the pulp and presence of bleeding upon exposure)\n\n * Patients with an age range from 7-8 years.\n * Absence of sinus tract, soft tissue swelling.\n\nExclusion Criteria:\n\n* • Molars were excluded if non-restorable.\n\n * excessive mobility (more than 1 mm horizontally).\n * Radiographic evidence of peri- and ⁄or inter-radicular lesions, internal⁄ external root resorption, pulp⁄ canal calcifications.'}, 'identificationModule': {'nctId': 'NCT03838094', 'briefTitle': 'Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '19119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MTA Group', 'description': 'pulpotomy technique using fast-setting mineral trioxide aggregate (MTA) to be considered the control group for vital pulp therapy and was placed over the amputated pulps for 18 months. This group will be compared with the Biodentine group as the intervention group', 'interventionNames': ['Biological: MTA']}, {'type': 'EXPERIMENTAL', 'label': 'Biodentine group', 'description': '3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration', 'interventionNames': ['Biological: Biodentine']}], 'interventions': [{'name': 'Biodentine', 'type': 'BIOLOGICAL', 'otherNames': ['Calcium silicate-based biomaterial'], 'description': 'it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.', 'armGroupLabels': ['Biodentine group']}, {'name': 'MTA', 'type': 'BIOLOGICAL', 'otherNames': ['mineral trioxide aggregate'], 'description': 'MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping', 'armGroupLabels': ['MTA Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gihan M Abuelniel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only final results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gihan M Abuelniel ,PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatric Dentistry', 'investigatorFullName': 'Gihan M Abuelniel ,PhD', 'investigatorAffiliation': 'Cairo University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-12-01', 'type': 'RELEASE'}, {'date': '2019-12-03', 'type': 'UNRELEASE'}, {'date': '2019-12-03', 'type': 'RELEASE'}, {'date': '2019-12-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gihan M Abuelniel ,PhD, Associate Professor of Pediatric Dentistry, Cairo University'}}}}