Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05279820
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2021-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participant will not be informed whether the treatment performed was partial or full pulpotomy the outcome assessor will be blinded to the type of treatment performed, and evaluation of the radiographs will include masking the crown so that the procedure cannot be identified.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2021-11-28', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain level measured by visual analogy scale from 0-10', 'timeFrame': '48 hours', 'description': 'scale from 0-10'}, {'measure': 'Post operative pain level measured by a numerical scale from 0-10', 'timeFrame': '48 hours', 'description': 'scale from 0-10'}], 'secondaryOutcomes': [{'measure': 'Clinical success as measured by clinical examination', 'timeFrame': '6, 12, 24 months', 'description': 'The tooth should be pain free, no sinus tract or swelling, no tenderness to palpation as determined by clinical examination'}, {'measure': 'Radiographic success as evaluated by periapical x-rays', 'timeFrame': '6, 12, 24 months', 'description': 'There should be no evidence of bone resorption or root resorption on the x-ray'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['irreversible pulpits', 'Pulpotomy', 'Outcome'], 'conditions': ['Carious Exposure of Pulp', 'Irreversible Pulpitis', 'Pulpotomy']}, 'referencesModule': {'references': [{'pmid': '32950193', 'type': 'BACKGROUND', 'citation': 'Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.'}]}, 'descriptionModule': {'briefSummary': 'This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up.\n\nThe study design will be a double blind randomized clinical trial.', 'detailedDescription': 'Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis\n\nMethods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm.\n\nPatients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded.\n\nPulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken.\n\nPrimary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively.\n\nData of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mature permanent tooth\n* Deep caries extending more than two thirds of dentine or exposing the pulp\n* Tooth responds positively to cold test\n* Clinical symptoms of irreversible pulpits\n* Tooth is restorable and can be restored with coronal restoration\n* Bleeding normally is confirmed after pulp exposure\n* hemostasis could be achieved within 8 minutes\n\nExclusion Criteria:\n\n* Non restorable teeth\n* necrotic teeth\n* hemostasis could not be achieved within 8 minutes'}, 'identificationModule': {'nctId': 'NCT05279820', 'briefTitle': 'Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits', 'organization': {'class': 'OTHER', 'fullName': 'Jordan University of Science and Technology'}, 'officialTitle': 'Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '329/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Partial Pulpotomy', 'description': 'After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored.', 'interventionNames': ['Procedure: Partial pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Full Pulpotomy', 'description': 'After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored.', 'interventionNames': ['Procedure: Full Pulpotomy']}], 'interventions': [{'name': 'Partial pulpotomy', 'type': 'PROCEDURE', 'description': 'Partial pulp tissue amputation', 'armGroupLabels': ['Partial Pulpotomy']}, {'name': 'Full Pulpotomy', 'type': 'PROCEDURE', 'description': 'Full Pulpotomy', 'armGroupLabels': ['Full Pulpotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22110', 'city': 'Irbid', 'status': 'RECRUITING', 'country': 'Jordan', 'contacts': [{'name': 'Nessrin Taha, DCD', 'role': 'CONTACT', 'email': 'n.taha@just.edu.jo'}], 'facility': 'Jordan University of science and technology', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}], 'centralContacts': [{'name': 'Nessrin Taha, PhD', 'role': 'CONTACT', 'email': 'n.taha@just.edu.jo', 'phone': '+962776566110'}, {'name': 'Nessrin Taha, PhD', 'role': 'CONTACT', 'email': 'nessrin_taha@yahoo.com'}], 'overallOfficials': [{'name': 'Nessrin Taha, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jordan University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Until the time of completion of the study, ankylosis of data and submission for publication, then data can be provided to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}