Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-30 @ 3:41 PM
Study NCT ID:
NCT05406557
Status:
UNKNOWN
Last Update Posted:
2022-06-06
First Post:
2022-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2022-05-29', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and radiographic success', 'timeFrame': 'Baseline to 12 Months', 'description': 'Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion.\n\nRADIOGRAPHIC SUCCESS CRITERIA:\n\nNo pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis.\n\nPeriapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique.\n\nNumber of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.'}], 'secondaryOutcomes': [{'measure': 'Pain analysis', 'timeFrame': 'Baseline to 7 days', 'description': 'To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain'}, {'measure': 'Pulp sensibility testing', 'timeFrame': 'Baseline to 12 months', 'description': 'To assess pulp tissue response using cold and electric pulp test at 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Irreversible pulpitis', 'Partial pulpotomy', 'Miniature pulpotomy', 'Vital pulp therapy'], 'conditions': ['Pulpitis - Irreversible']}, 'referencesModule': {'references': [{'pmid': '39352296', 'type': 'DERIVED', 'citation': 'Ramani A, Sangwan P, Duhan J, Popat S, Sangwan A. Effect of lateral extent of pulp tissue removal on the outcome of partial pulpotomy for managing cariously exposed mature permanent molars with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2025 Jan;58(1):71-83. doi: 10.1111/iej.14152. Epub 2024 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis', 'detailedDescription': 'After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing.\n\nOnce included, study subjects will be randomly allocated to either Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in same appointment.\n\nPain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 6 and 12 months from baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient with18 -45 years of age.\n* Restorable molar teeth.\n* Tooth should give positive response to pulp sensibility testing.\n* Clinical diagnosis of symptomatic partial irreversible pulpitis.\n* Tooth with probing pocket depth and mobility are within normal limits.\n* No signs of pulpal necrosis including sinus tract or swelling.\n* Non-contributory medical history\n\nExclusion Criteria:\n\n* Teeth with immature roots.\n* No pulp exposure after caries excavation.\n* Bleeding could not be controlled in 6 minutes.\n* Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic'}, 'identificationModule': {'nctId': 'NCT05406557', 'briefTitle': 'Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Outcome Comparing Partial and Miniature Pulpotomy in Mature Permanent Molars With Symptomatic Partial Irreversible Pulpitis', 'orgStudyIdInfo': {'id': 'DR. A RAMANI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Partial pulpotomy', 'description': 'Removal of superficial 2-3 mm of pulp tissue from entire pulp chamber', 'interventionNames': ['Procedure: Partial pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Miniature pulpotomy', 'description': 'Removal of superficial 2-3 mm of pulp tissue from only affected pulp horn', 'interventionNames': ['Procedure: Miniature pulpotomy']}], 'interventions': [{'name': 'Partial pulpotomy', 'type': 'PROCEDURE', 'description': 'In case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of pulp chamber.', 'armGroupLabels': ['Partial pulpotomy']}, {'name': 'Miniature pulpotomy', 'type': 'PROCEDURE', 'description': 'In case of miniature pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of only affected pulp horn', 'armGroupLabels': ['Miniature pulpotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'DR. ANKITA RAMANI, MDS', 'role': 'CONTACT', 'email': 'ramaniankita95@gmail.com', 'phone': '09582841539'}], 'facility': 'Dr. Ankita Ramani', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'centralContacts': [{'name': 'DR. ANKITA RAMANI, MDS', 'role': 'CONTACT', 'email': 'ramaniankita95@gmail.com', 'phone': '+919582841539'}, {'name': 'DR. PANKAJ SANGWAN, MDS', 'role': 'CONTACT', 'email': 'drps_1@yahoo.com', 'phone': '9996112202'}], 'overallOfficials': [{'name': 'DR. ANKITA RAMANI, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PGIDS, ROHTAK, HARYANA, INDIA-124001'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}