Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT07179835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Periapical Healing Post Full Pulpotomy in Teeth With and Without Apical Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success following complete pulpotomy', 'timeFrame': '12 MONTHS', 'description': 'Clinical-Radiographic Success After Full Pulpotomy in Mandibular Molars With and Without Apical Periodontitis"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apical Periodontitis']}, 'descriptionModule': {'briefSummary': 'This clinical study aims to evaluate the periapical and clinical healing outcomes of full pulpotomy using MTA in mandibular permanent molars diagnosed with symptomatic irreversible pulpitis. Patients will be stratified based on the presence or absence of apical periodontitis. Clinical and radiographic assessments will be conducted at baseline, 6 months, and 12 months to compare healing outcomes between groups. The study seeks to determine the effectiveness of full pulpotomy as a less invasive alternative to root canal treatment, even in teeth with apical pathosis.', 'detailedDescription': 'This prospective clinical study aims to evaluate the periapical and clinical healing outcomes of full pulpotomy using mineral trioxide aggregate (MTA) in mandibular permanent molars diagnosed with symptomatic irreversible pulpitis. Patients will be stratified based on the presence or absence of apical periodontitis. Clinical and radiographic assessments will be conducted at baseline, 6 months, and 12 months to compare healing outcomes between groups. The study seeks to determine the effectiveness of full pulpotomy as a less invasive alternative to root canal treatment, even in teeth with apical pathosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient should be ≥18 years of age.\n2. Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)\n3. Tooth should give positive response to pulp sensibility testing.\n4. Radiographic finding of periapical index (PAI) score \\>/=3 (for test group) , score \\</= 2 (for control group)\n\nExclusion criteria\n\n1. Teeth with immature roots.\n2. No pulp exposure after caries excavation.\n3. Bleeding could not be controlled in 10 minutes.\n4. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.\n5. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.\n6. Internal/external resorption.\n7. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)'}, 'identificationModule': {'nctId': 'NCT07179835', 'briefTitle': 'To Evaluate Periapical Healing Post Full Pulpotomy in Teeth With and Without Apical Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'To Evaluate Periapical Healing Post Full Pulpotomy in Permanent Mandibular Teeth With and Without Apical Periodontitis', 'orgStudyIdInfo': {'id': 'Jigyasa Duhan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'To evaluate success of full pulpotomy in mandibular permanent with apical periodontitis', 'description': 'To evaluate success of full pulpotomy based on clinical and radiographic criteria in mandibular permanent with apical periodontitis', 'interventionNames': ['Procedure: Full pulpotomy in adults ≥18 years with restorable mandibular first or second molars diagnosed with irreversible pulpitis, with or without apical periodontitis.']}, {'type': 'EXPERIMENTAL', 'label': 'To evaluate success of full pulpotomy in mandibular permanent without apical periodontitis', 'description': 'To evaluate and compare success of full pulpotomy based on clinical and radiographic criteria in mandibular permanent withoutapical periodontitis', 'interventionNames': ['Procedure: Full pulpotomy in adults ≥18 years with restorable mandibular first or second molars diagnosed with irreversible pulpitis, with or without apical periodontitis.']}], 'interventions': [{'name': 'Full pulpotomy in adults ≥18 years with restorable mandibular first or second molars diagnosed with irreversible pulpitis, with or without apical periodontitis.', 'type': 'PROCEDURE', 'description': 'Comparison of full pulpotomy with MTA in teeth with and without apical periodontitis', 'armGroupLabels': ['To evaluate success of full pulpotomy in mandibular permanent with apical periodontitis', 'To evaluate success of full pulpotomy in mandibular permanent without apical periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'contacts': [{'name': 'Dr.Jigyasa Duhan, MDS', 'role': 'CONTACT', 'email': 'prashitiduhan@gmail.com', 'phone': '9896270449'}], 'facility': 'PGIDS, Rohtak', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'centralContacts': [{'name': 'Jigyasa Duhan, MDS', 'role': 'CONTACT', 'email': 'prashitiduhan@rediffmail.com', 'phone': '9896270449'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}