Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT06714305
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2024-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Effectiveness of Hand Versus Rotary Instrumentation in Pulpectomy of Primary Second Molar Teeth.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the effectiveness of manual versus rotary instrumentation for pulpectomy in primary second molar teeth irreversible pulpitis', 'timeFrame': 'immediately after obturation', 'description': 'Effectiveness of instruments will be determined by analyzing the adequacy of root canal filling. Adequacy will be checked immediately after root canal filling on periapical radiographs by measuring with scale the distance of root canal filling from apex to length of filling material in both mesial and distal roots. If distance is less than 2.5 mm, it will be called as effective.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Irreversible Pulpitis (toothache)']}, 'descriptionModule': {'briefSummary': 'To provide an effective technique for pulpectomy in primary second molar teeth in pakistani population, local studies are required. No local studies have been done so far and limited number of international in vivo studies have been conducted previously. Hence this study will evaluate the effectiveness of this technique in pakistani population. If results of this study will be significant in favor of this technique, it will be applied with confidence in same population. There will be better compliance of patients as procedure will be done in single visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children of both genders having age 4-6.5 years\n2. Children having signs and symptoms of irreversible pulpitis in their second primary molar teeth on clinical examination as per operational definition.\n\nExclusion Criteria:\n\n1. Children having previously accessed pulpectomy assessed clinically and on periapical radiographs.\n2. Children having acute/chronic abcesses in teeth under consideration seen clinically.\n3. Children having furcal or periapical radiolucency around teeth under consideration seen on periapical radiograph.\n4. Diabetic, haemophilic or medically compromised children found on history\n5. Children who fail to attend appointments.'}, 'identificationModule': {'nctId': 'NCT06714305', 'briefTitle': 'Comparison of Effectiveness of Hand Versus Rotary Instrumentation in Pulpectomy of Primary Second Molar Teeth.', 'organization': {'class': 'OTHER', 'fullName': 'Shaheed Zulfiqar Ali Bhutto Medical University'}, 'officialTitle': 'Comparison of Effectiveness of Hand Versus Rotary Instrumentation in Pulpectomy of Primary Second Molar Teeth.', 'orgStudyIdInfo': {'id': 'CPSP/REU/2014-077-1257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A will be assigned to hand instrumentation.', 'description': 'the canal will be prepared by hand hedstorm files, manually by step back technique.', 'interventionNames': ['Device: will be assigned to rotary instrumentation.']}, {'type': 'EXPERIMENTAL', 'label': 'rotary instrumentation of primary second molar tooth', 'description': 'NiTi rotary protaper system will be used for canal preparation by crown down technique in primary second molar tooth', 'interventionNames': ['Device: Group B will be assigned to rotary instrumentation.']}], 'interventions': [{'name': 'Group B will be assigned to rotary instrumentation.', 'type': 'DEVICE', 'description': 'group B, NiTi rotary protaper system will be used for canal preparation by crown down technique.', 'armGroupLabels': ['rotary instrumentation of primary second molar tooth']}, {'name': 'will be assigned to rotary instrumentation.', 'type': 'DEVICE', 'description': 'the canal will be prepared by conventional hedstorm files manually by step back technique.', 'armGroupLabels': ['Group A will be assigned to hand instrumentation.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Nishter Institute of Dentistry', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RANA AHMAD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator, Assistant professor (Clinical), Depatment of Operative dentistry, School of dentistry', 'investigatorFullName': 'RANA AHMAD', 'investigatorAffiliation': 'Shaheed Zulfiqar Ali Bhutto Medical University'}}}}