Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 5:46 PM
Study NCT ID:
NCT07472751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Bacterial Reduction After Pulpectomy in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The blinding of operator is not possible due to the nature of the technique used'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracanal Bacterial Load Reduction', 'timeFrame': 'Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.', 'description': 'Reduction in intracanal bacterial count after chemo-mechanical preparation during pulpectomy of primary molars. Microbiological samples will be collected from the root canals before instrumentation (S1) and after completion of instrumentation (S2) using sterile paper points. Samples will be cultured on brain heart infusion agar plates, and bacterial growth will be quantified by counting colony-forming units (CFU). The difference in CFU between S1 and S2 will be used to determine the level of bacterial reduction achieved by rotary instrumentation compared with manual instrumentation.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': 'at 6, 12, 24, 48, and 72 hours and 1 week after treatment.', 'description': 'Asking the patient and/or Guardian using a 4-point pain scale, the parent of each participant will receive 6 flashcards that include four faces and a word describing each face.'}, {'measure': "child's behavior level.", 'timeFrame': 'Immediately after treatment.', 'description': 'will be recorded by using the FRANKEL behavior rating scale: rate 1 means definitely negative "refusal of treatment, fearfulness"; rate 2 means negative "reluctance to accept treatment, uncooperative"; rate 3 means positive "acceptance of treatment, patient follows the dentist\'s directions"; Rate 4 means definitely positive "good rapport with the dentist, laughter, and enjoyment."'}, {'measure': 'Instrumentation time', 'timeFrame': 'during the procedure, starting from anesthesia till end of procedure', 'description': 'stopwatch'}, {'measure': 'Clinical success', 'timeFrame': 'At 3, 6, and 12 months', 'description': '1. absence of swelling will be recorded by visual examination\n2. absence of sinus or fistula will be recorded by visual examination\n3. pathologic mobility will be recorded by mobility test (pressure using the end of two dental mirrors)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric endodontics', 'Intracanal bacterial reduction', 'Endodontic treatment in children', 'Chemo-mechanical preparation', 'Pulpectomy', 'primary molars', 'Bacterial load reduction'], 'conditions': ['Irreversible Pulpitis']}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to compare the bacterial reduction in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation.', 'detailedDescription': 'This study aims to compare the antibacterial effectiveness of a single rotary file system with conventional manual instrumentation during pulpectomy of primary molars. The study will evaluate bacterial reduction by microbiological culture techniques using colony-forming units per milliliter (CFU/mL) before and after chemo-mechanical preparation.\n\nThis investigation will include both in vitro and in vivo components to provide a comprehensive evaluation of bacterial reduction. In the clinical part of the study, children aged 4 to 6 years with restorable mandibular second primary molars diagnosed with irreversible pulpitis will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department at the Faculty of Dentistry, Cairo University. Eligible teeth will undergo pulpectomy and will be randomly assigned to one of two groups:\n\nGroup 1: Pulpectomy using a single rotary file system. Group 2: Pulpectomy using conventional manual stainless-steel K-files.\n\nMicrobiological samples will be collected from the root canals before instrumentation and after completion of chemo-mechanical preparation using sterile paper points. The samples will be transferred to brain-heart infusion broth and cultured on agar plates under aerobic and anaerobic conditions. Bacterial growth will be quantified by counting colony-forming units to determine the degree of bacterial reduction produced by each instrumentation technique.\n\nThe findings of this study will contribute to evidence-based decision-making in pediatric endodontics by clarifying whether rotary instrumentation provides superior bacterial reduction compared with manual instrumentation in primary molar pulpectomy. Improved understanding of the antimicrobial effectiveness of these techniques may help clinicians select instrumentation methods that enhance treatment success, reduce chairside time, and improve patient cooperation during pediatric dental procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children age 4 to 6 years\n* Medically free children\n* Cooperative children\n* Restorable mandibular second primary molars with signs or symptoms of irreversible pulpitis\n* No internal root resorption on radiograph\n* No external root resorption on radiograph\n* No periapical radiolucency\n* No inter-radicular radiolucency\n\nExclusion Criteria:\n\n* Uncooperative children\n* Children with systemic disease\n* Children with physical disability\n* Children with mental disability\n* Refusal to participate\n* Inability to attend follow-up visits\n* Refusal to sign consent form\n* Previously accessed teeth\n* Mobile mandibular primary molars\n* Pain on percussion\n* Swelling on palpation or in the vestibule'}, 'identificationModule': {'nctId': 'NCT07472751', 'briefTitle': 'Evaluation of Bacterial Reduction After Pulpectomy in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Evaluation of Bacterial Reduction Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars: An In Vitro and In Vivo Study', 'orgStudyIdInfo': {'id': 'pedo-3-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotary Instrumentation Group', 'description': 'Single Rotary File System', 'interventionNames': ['Procedure: Rotary Instrumentation']}, {'type': 'EXPERIMENTAL', 'label': 'Manual Instrumentation Group', 'description': 'Manual Stainless Steel K-File Instrumentation', 'interventionNames': ['Procedure: Manual Instrumentation']}], 'interventions': [{'name': 'Rotary Instrumentation', 'type': 'PROCEDURE', 'description': 'After opening the access cavity, the root canal patency will be checked for all the canals located using a size #15 (0.02%) K file, then a single rotary file (AF F One, FANTA, China) (20 taper 4) will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). This file will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline.', 'armGroupLabels': ['Rotary Instrumentation Group']}, {'name': 'Manual Instrumentation', 'type': 'PROCEDURE', 'description': 'After opening the access cavity, manual files (K files, Mani, Inc., Japan) of sizes 15, 20, 25, and 30 will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). These files will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline.', 'armGroupLabels': ['Manual Instrumentation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11411', 'city': 'Cairo', 'state': 'Egypt', 'country': 'Egypt', 'contacts': [{'name': 'Aya G Abd elzaher, master', 'role': 'CONTACT', 'email': 'aya_gamal@dentistry.cu.edu.eg', 'phone': '+01100480444'}], 'facility': 'Faculty of dentistry, Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Aya G Abd elzaher, master', 'role': 'CONTACT', 'email': 'aya_gamal@dentistry.cu.edu.eg', 'phone': '+01100480444'}, {'name': 'Hanaa A Abd el moniem', 'role': 'CONTACT', 'email': 'hanaa.ibraheem@dentistry.cu.edu.eg'}], 'overallOfficials': [{'name': 'Gihan M Abu elniel, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'candidate in department of pediatric dentistry and dental public health department, faculty of dentistry, Cairo university', 'investigatorFullName': 'Aya Gamal Abd Elzaher', 'investigatorAffiliation': 'Cairo University'}}}}