Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-01 @ 9:13 AM
Study NCT ID:
NCT06973057
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-15
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Pulp Capping Versus Pulpotomy for Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011672', 'term': 'Pulpotomy'}], 'ancestors': [{'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A split mouth randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success', 'timeFrame': '24 months', 'description': 'No post-treatment signs or symptoms such as sensitivity, pain, mobility or swelling should be evident.'}, {'measure': 'Radiographic success', 'timeFrame': '24 months', 'description': 'No radiographic evidence of pathologic external or internal root resorption, periapical or furcation radiolucency.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vital Pulp therapies', 'Direct pulp capping', 'Pulpotomy', 'Neo MTA', 'Primary molars', 'Randomized clinical trial'], 'conditions': ['Vital Pulp Therapies']}, 'referencesModule': {'references': [{'pmid': '30788777', 'type': 'RESULT', 'citation': 'Dimitraki D, Papageorgiou SN, Kotsanos N. Direct pulp capping versus pulpotomy with MTA for carious primary molars: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):431-440. doi: 10.1007/s40368-019-00419-7. Epub 2019 Feb 20.'}, {'pmid': '30992107', 'type': 'RESULT', 'citation': 'Alsanouni M, Bawazir OA. A Randomized Clinical Trial of NeoMTA Plus in Primary Molar Pulpotomies. Pediatr Dent. 2019 Mar 15;41(2):107-111.'}, {'pmid': '36947754', 'type': 'RESULT', 'citation': 'ElSebaai A, Wahba AH, Grawish ME, Elkalla IH. Calcium Hydroxide Paste, Mineral Trioxide Aggregate, and Formocresol as Direct Pulp Capping Agents in Primary Molars: A Randomized Controlled Clinical Trial. Pediatr Dent. 2022 Nov 15;44(6):411-417.'}, {'pmid': '35780237', 'type': 'RESULT', 'citation': 'Chatzidimitriou K, Vadiakas G, Koletsi D. Direct pulp capping in asymptomatic carious primary molars using three different pulp capping materials: a prospective clinical trial. Eur Arch Paediatr Dent. 2022 Oct;23(5):803-811. doi: 10.1007/s40368-022-00720-y. Epub 2022 Jul 2.'}, {'pmid': '35799339', 'type': 'RESULT', 'citation': 'Canoglu E, Gungor HC, Uysal S. Direct Pulp Capping of Primary Molars with Calcium Hydroxide or MTA Following Hemorrhage Control with Different Medicaments: Randomized Clinical Trial. Pediatr Dent. 2022 May 15;44(3):167-173.'}], 'seeAlsoLinks': [{'url': 'https://www.aapd.org/media/Policies_Guidelines/BP_PulpTherapy.pdf', 'label': 'Pulp Therapy for Primary and Immature Permanent Teeth'}]}, 'descriptionModule': {'briefSummary': 'Dental caries is one of the most prevalent chronic diseases worldwide. Interventions for treating deep carious lesions in teeth with no history of pain or teeth with reversible pulpitis are referred to as vital pulp therapy; these include indirect pulp treatment (IPC), direct pulp capping (DPC), and pulpotomy. Pulpotomy is considered invasive when treating exposed primary vital pulps due to caries. Less invasive vital pulp treatment methods such as DPC might, therefore, be preferable, as they reduce chair time, less tooth structure removal and a crown might not always be a necessary permanent restoration. The aim of this clinical study is to evaluate the clinical and radiographic outcomes of DPC when compared to pulpotomy in primary molars with carious pulp exposure.', 'detailedDescription': 'Aim: The aim of this study is to evaluate the clinical and radiographic outcomes of direct pulp capping (DPC) when compared to pulpotomy in primary molars with carious pulp exposure using a calcium silicate-based material: neo mineral trioxide aggregate (Neo MTA).\n\nMethods: The study will be a split mouth randomized clinical trial including children between 4-9 years old. Patients will be allocated into two treatment groups; one group will start with DPC first followed by pulpotomy on the second visit, and vice versa for the second group. The time interval between both visits will be 1-2 weeks. The pulp medicament capping material (neo MTA) will be applied over the exposure site, and then tooth will be restored with glass ionomer cement and then a crown will be placed. Cases will be followed up to 24 months after initial treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy patients.\n* Age 4-10 years.\n* Primary molar with deep caries present bilaterally.\n* Teeth should be restorable.\n* Clinically normal asymptomatic tooth or symptoms of reversible pulpitis (No history of pain or provoked pain subsides upon removal of the stimulus).\n* Radiographically: caries in the inner half of the dentin approaching the pulp.\n\nExclusion Criteria:\n\n* History of spontaneous pain.\n* Soft and hard tissue pathology.\n* Mobility or exfoliating tooth.\n* No pulp exposure after caries excavation.\n* Inability to achieve hemostasis after 6 minutes.\n* Radiographically: Root resorption exceeding 1/3 of the root, apical pathology.'}, 'identificationModule': {'nctId': 'NCT06973057', 'acronym': 'MTA', 'briefTitle': 'Direct Pulp Capping Versus Pulpotomy for Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah University Hospital'}, 'officialTitle': 'Direct Pulp Capping Versus Pulpotomy Using Neo MTA for Carious Primary Molars: a Split Mouth Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '341-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pulpotomy', 'description': 'The entire coronal pulp will be amputated.', 'interventionNames': ['Procedure: Pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct pulp capping', 'description': 'The exposure site will be left intact, no amputation of pulp tissue.', 'interventionNames': ['Procedure: Direct pulp capping (DPC)']}], 'interventions': [{'name': 'Pulpotomy', 'type': 'PROCEDURE', 'description': 'The entire coronal pulp will be amputated to the level of canal orifices, after hemostasis, NeoMTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.', 'armGroupLabels': ['Pulpotomy']}, {'name': 'Direct pulp capping (DPC)', 'type': 'PROCEDURE', 'description': 'At the exposure site hemostasis will be achieved, neo MTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.', 'armGroupLabels': ['Direct pulp capping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22110', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'Jordan Univeristy of Science and Technology', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}], 'overallOfficials': [{'name': 'OLA Al-Batayneh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}