Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT03890835
Status:
UNKNOWN
Last Update Posted:
2019-03-26
First Post:
2019-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The study will be participant-blind where the participant will not know the intervention done.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2019-03-17', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain after 6 hours postoperatively', 'timeFrame': '6 hours postoperatively', 'description': 'Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.\n\n0 reading represents "no pain"\n\n1- 3 readings represent "mild pain"\n\n4- 6 readings represent "moderate pain"\n\n7- 10 readings represent "severe pain"'}, {'measure': 'Postoperative pain after 12 hours postoperatively', 'timeFrame': '12 hours postoperatively', 'description': 'Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.\n\n0 reading represents "no pain"\n\n1- 3 readings represent "mild pain"\n\n4- 6 readings represent "moderate pain"\n\n7- 10 readings represent "severe pain"'}, {'measure': 'Postoperative pain after 24 hours postoperatively', 'timeFrame': '24 hours postoperatively', 'description': 'Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.\n\n0 reading represents "no pain"\n\n1- 3 readings represent "mild pain"\n\n4- 6 readings represent "moderate pain"\n\n7- 10 readings represent "severe pain"'}], 'secondaryOutcomes': [{'measure': 'Overall (clinical and radiographic) success after 6 months postoperatively.', 'timeFrame': '6 months postoperatively', 'description': 'Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure.'}, {'measure': 'Overall (clinical and radiographic) success after 12 months postoperatively.', 'timeFrame': '12 months postoperatively', 'description': 'Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulpotomy', 'Mineral Trioxide Aggregate (MTA)', 'Biodentine', 'Vital pulp therapy', 'Postoperative pain', 'Overall success'], 'conditions': ['Symptomatic Irreversible Pulpitis']}, 'referencesModule': {'references': [{'pmid': '24771228', 'type': 'BACKGROUND', 'citation': 'Asgary S, Eghbal MJ, Fazlyab M, Baghban AA, Ghoddusi J. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial. Clin Oral Investig. 2015 Mar;19(2):335-41. doi: 10.1007/s00784-014-1244-z. Epub 2014 Apr 27.'}, {'pmid': '29061359', 'type': 'BACKGROUND', 'citation': 'Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.'}, {'pmid': '28822566', 'type': 'BACKGROUND', 'citation': 'Bakhtiar H, Nekoofar MH, Aminishakib P, Abedi F, Naghi Moosavi F, Esnaashari E, Azizi A, Esmailian S, Ellini MR, Mesgarzadeh V, Sezavar M, About I. Human Pulp Responses to Partial Pulpotomy Treatment with TheraCal as Compared with Biodentine and ProRoot MTA: A Clinical Trial. J Endod. 2017 Nov;43(11):1786-1791. doi: 10.1016/j.joen.2017.06.025. Epub 2017 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.', 'detailedDescription': '* Patients will be clinically and radiographically examined and their eligibility will be assessed.\n* Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA).\n* After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA\n* The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken.\n* The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times.\n* The patients will be recalled after 6 and 12 months post-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aging between 18-40 years old\n* Patients with symptomatic irreversible pulpitis.\n* Radiographically: Absence or slight widening in periodontal ligament space.\n* Systemically- healthy patients (ASA I or II).\n* Patients who agree to attend for recall appointments and provide written consent.\n\nExclusion Criteria:\n\n* Severe marginal periodontitis.\n* Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula.\n* Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.'}, 'identificationModule': {'nctId': 'NCT03890835', 'briefTitle': 'Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Evaluation of Postoperative Pain and Success Rate After Pulpotomy in Mature Permanent Molars Using Biodentine Versus Mineral Trioxide Aggregate (MTA) as Capping Materials: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-2019-03-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mineral Trioxide Aggregate (MTA)', 'interventionNames': ['Procedure: MTA Pulpotomy.']}, {'type': 'EXPERIMENTAL', 'label': 'Biodentine', 'interventionNames': ['Procedure: Biodentine Pulpotomy']}], 'interventions': [{'name': 'MTA Pulpotomy.', 'type': 'PROCEDURE', 'description': 'Pulpotomy using MTA.', 'armGroupLabels': ['Mineral Trioxide Aggregate (MTA)']}, {'name': 'Biodentine Pulpotomy', 'type': 'PROCEDURE', 'description': 'Pulpotomy using Biodentine', 'armGroupLabels': ['Biodentine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Youssef A. Kamal Elalfy, B.D.S', 'role': 'CONTACT', 'email': 'Youssef_Andraws@dentistry.cu.edu.eg', 'phone': '+201286069484'}, {'name': 'Suzan AW Amin, Ph.D.', 'role': 'CONTACT', 'email': 'swaness@rocketmail.com'}], 'overallOfficials': [{'name': 'Youssef A. Kamal Elalfy, B.D.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University', 'investigatorFullName': 'Youssef Andraws', 'investigatorAffiliation': 'Cairo University'}}}}