Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:30 PM
Study NCT ID:
NCT07304869
Status:
COMPLETED
Last Update Posted:
2025-12-26
First Post:
2025-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Durations for Endodontic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of each procedural step in endodontic treatment', 'timeFrame': 'From the start of access cavity preparation to the completion of coronal restoration during a single treatment visit (approximately 35-120 minutes).', 'description': 'The duration (in seconds) of each of seven key procedural stages performed during routine root canal treatment on maxillary first molar teeth:\n\n1. Access cavity preparation\n2. Working length determination\n3. Canal shaping\n4. MB2 canal detection and shaping\n5. Final irrigation and passive ultrasonic activation\n6. Root canal filling\n7. Coronal restoration\n\nEach stage was timed separately for three groups (direct vision, dental loupes, and dental operating microscope) to compare the effect of different magnification techniques on working efficiency.'}], 'secondaryOutcomes': [{'measure': 'Presence of MB2 canal according to magnification technique', 'timeFrame': 'Baseline (at the time of canal orifice identification)', 'description': 'The presence or absence of a second mesiobuccal (MB2) canal in maxillary first molar teeth will be recorded for each magnification group (direct vision, dental loupes, and dental operating microscope). The association between the magnification method and MB2 canal detection will be evaluated using the Chi-square test (Monte Carlo simulation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['root canal treatment', 'Dental operating microscope', 'dental loupes', 'chair time', 'second mesiobuccal canal'], 'conditions': ['Root Canal Therapy']}, 'referencesModule': {'references': [{'pmid': '12043874', 'type': 'BACKGROUND', 'citation': 'Buhrley LJ, Barrows MJ, BeGole EA, Wenckus CS. Effect of magnification on locating the MB2 canal in maxillary molars. J Endod. 2002 Apr;28(4):324-7. doi: 10.1097/00004770-200204000-00016.'}, {'pmid': '25887978', 'type': 'BACKGROUND', 'citation': 'Wong AW, Zhu X, Zhang S, Li SK, Zhang C, Chu CH. Treatment time for non-surgical endodontic therapy with or without a magnifying loupe. BMC Oral Health. 2015 Mar 20;15:40. doi: 10.1186/s12903-015-0025-7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to compare the treatment durations of different stages of routine root canal therapy performed on maxillary molar teeth using direct vision, magnification loupes, and a dental operating microscope.\n\nThe primary question the study seeks to answer is whether there is a significant difference in the duration of endodontic procedures performed under different magnification techniques.\n\nPatients indicated for root canal treatment in their maxillary first molar teeth will receive standard root canal therapy in accordance with routine clinical protocols. The duration of each procedural step will be recorded and subsequently compared among the three magnification methods.', 'detailedDescription': 'In this observational study, routine root canal treatment procedures will be performed in accordance with standard endodontic protocols on patients who applied to the Department of Endodontics, Faculty of Dentistry, Uşak University, and were indicated for root canal treatment on their maxillary first molar teeth.\n\n1. The treatment procedures consist of seven main stages:\n2. Preparation of the access cavity\n3. Determination of the working length\n4. Shaping of the root canals\n5. Detection and shaping of the MB2 canal\n6. Final irrigation and passive ultrasonic activation\n7. Root canal filling\n\nApplication of the coronal restoration\n\nAll steps will be carried out according to standard clinical endodontic protocols under rubber dam isolation. The duration of each stage will be recorded individually.\n\nParticipants will be divided into three groups based on the magnification technique used during treatment:\n\nGroup 1: Treatments performed under direct vision\n\nGroup 2: Treatments performed using dental loupes\n\nGroup 3: Treatments performed using a dental operating microscope\n\nAll procedures in each group will follow the same standardized root canal treatment protocol, differing only in the magnification technique employed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the Department of Endodontics, Faculty of Dentistry, Uşak University, who required root canal treatment of maxillary first molar teeth', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring root canal treatment of the maxillary first molar tooth\n\nExclusion Criteria:\n\n* Previous root canal treatment on the maxillary first molar tooth\n* Presence of fracture or crack in the maxillary first molar tooth\n* Lack of indication for completing treatment in a single session\n* Patient refusal to continue treatment during the procedure\n* Indication for extraction due to complications during treatment\n* Teeth indicated for fiber post restoration due to excessive material loss'}, 'identificationModule': {'nctId': 'NCT07304869', 'briefTitle': 'Treatment Durations for Endodontic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Uşak University'}, 'officialTitle': 'Comparison of Treatment Durations for Endodontic Procedures on Maxillary Molar Teeth Using Different Magnification Techniques', 'orgStudyIdInfo': {'id': '558-558-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated under direct vision', 'description': 'Root canal treatment of maxillary first molar teeth performed without magnification, using direct visual inspection only.'}, {'label': 'Patients treated using dental loupes', 'description': 'Root canal treatment of maxillary first molar teeth performed using 5× magnification dental loupes.'}, {'label': 'Patients treated using a dental operating microscope', 'description': 'Root canal treatment of maxillary first molar teeth performed using a dental operating microscope at 8×-16× magnification.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64000', 'city': 'Uşak', 'country': 'Turkey (Türkiye)', 'facility': 'Uşak University Faculty of Dentistry, Department of Endodontics', 'geoPoint': {'lat': 38.67351, 'lon': 29.4058}}], 'overallOfficials': [{'name': 'Oğuz Tavşan, Assistant Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uşak University Faculty of Dentistry, Department of Endodontics'}, {'name': 'Tuğçe N Çağlar, Research Assistant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uşak University Faculty of Dentistry, Department of Endodontics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data collected in this study will not be shared with other researchers. Data will be used only for academic purposes within the scope of the thesis and institutional ethics approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uşak University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Oğuz Tavşan', 'investigatorAffiliation': 'Uşak University'}}}}