Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT06807320
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2025-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002126', 'term': 'Calcium Hydroxide'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dentine bridge thickness (DBT)', 'timeFrame': '3 and 6 months follow up appointment in all successful cases.', 'description': 'Dentine bridge thickness (DBT) was measured at the 3 and 6 months follow up appointment in all successful cases.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indirect Pulp cap', 'primary molar', 'MTA'], 'conditions': ['Indirect Pulp Cap']}, 'descriptionModule': {'briefSummary': 'The study is designed as randomized clinical trial performed at the Department of Pediatric Dentistry , Pakistan Institute of Medical Sciences (PIMS) , Islamabad on primary molars requiring indirect pulp treatment in patients aged 5 to 9 years. Two groups , I and II of 40 teeth each will be selected according to inclusion criteria . In Group I , indirect pulp capping will be done with Calcium hydroxide while in Group II , it will be done with MTA . Both the groups will be evaluated clinically and radiographically at 0, 3 and 6 months . Results were compiled and analyzed using standard statistical techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Criteria :\n\n * Primary molars with deep carious lesions\n * No H/O spontaneous pain\n * No associated swelling\n * No tenderness to percussion\n * Absence of pathological mobility\n * No sinus tract\n * Restorable\n\nRadiographic Criteria :\n\n* No periapical radiolucency\n* No loss of lamina dura\n* No physiological root resorption\n* Teeth with radiographic evidence of more than 0.25mm remaining dentin thickness\n* No furcal radiolucency\n\nExclusion Criteria:\n\n* Non restorable teeth\n\n * Teeth with pathological mobility\n * Teeth with extensive external/internal root resorption.\n * Teeth with pulp canal calcifications\n * Subjects inability to tolerate any of the dental products being used\n * Systemic disease or severe medical complications ; Lack of compliance'}, 'identificationModule': {'nctId': 'NCT06807320', 'briefTitle': 'COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS', 'organization': {'class': 'OTHER', 'fullName': 'Shaheed Zulfiqar Ali Bhutto Medical University'}, 'officialTitle': 'CLINICAL and RADIOGRAPHIC COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS: a RANDOMIZED CLINICAL TRIAL', 'orgStudyIdInfo': {'id': 'F.1-1/2015/ERB/SZABMU/ERB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I patients, Calcium hydroxide', 'description': "For Group I patients, Calcium hydroxide (Dycal\\_ Ivory,Dentsply Caulk, Dentsply, L.D. Caulk, Milford, DE,USA ) was used. The catalyst and paste were mixed as per the manufacturer's recommendations.", 'interventionNames': ['Drug: Calcium Hydroxide (Ca(OH)2)']}, {'type': 'EXPERIMENTAL', 'label': 'Group II patients, MTA', 'description': 'MTA powder ( ProRoot; Dentsply ⁄ Tulsa Dental, Tulsa, OK,USA) was added to sterile water. The mixture was left to achieve a sandy consistency for about thirty seconds. Then, the material was applied to the cavity using a ball condenser.', 'interventionNames': ['Drug: MTA pulp dressing material']}], 'interventions': [{'name': 'MTA pulp dressing material', 'type': 'DRUG', 'description': 'MTA powder ( ProRoot; Dentsply ⁄ Tulsa Dental, Tulsa, OK,USA) was added to sterile water. The mixture was left to achieve a sandy consistency for about thirty seconds. Then, the material was applied to the cavity using a ball condenser.', 'armGroupLabels': ['Group II patients, MTA']}, {'name': 'Calcium Hydroxide (Ca(OH)2)', 'type': 'DRUG', 'description': "For Group I patients, Calcium hydroxide (Dycal\\_ Ivory,Dentsply Caulk, Dentsply, L.D. Caulk, Milford, DE,USA ) was used. The catalyst and paste were mixed as per the manufacturer's recommendations.", 'armGroupLabels': ['Group I patients, Calcium hydroxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Capital', 'country': 'Pakistan', 'facility': 'Pakistan Institute of Medical Sciences', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaheed Zulfiqar Ali Bhutto Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR', 'investigatorFullName': 'RANA AHMAD', 'investigatorAffiliation': 'Shaheed Zulfiqar Ali Bhutto Medical University'}}}}