Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 2:32 PM
Study NCT ID:
NCT04875650
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2021-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars
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': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Pain Score', 'timeFrame': 'Day 1', 'description': 'Use of a Visual Analogue Scale with 0 meaning no pain and 100 meaning severe pain'}, {'measure': 'Soft Tissue Healing Post Extraction', 'timeFrame': 'Day 3', 'description': 'Soft Tissue Healing Index by Landry et al.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Day 1', 'description': '4 point likert scale where 1 is very dissatisfied and 4 is very satisfied'}, {'measure': 'Success of Extraction', 'timeFrame': 'Day 1', 'description': '1 is Failure, 2 is limited success with osteotomy, 3 is limited success with root fracture, 4 is limited success with apical fracture and 5 is complete success'}, {'measure': 'Incidence of Alveolar Bone Fracture', 'timeFrame': 'Day 1', 'description': 'Fracture 1 and No fracture 0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tooth Extraction']}, 'descriptionModule': {'briefSummary': 'Our study compared two different forceps for extraction of mandibular molars, the conventional extraction forceps and the Physics forceps. We assesed the relative pain score, patient satisfaction, success of extraction, incidence of alveolar plate fracture and soft tissue healing; post extraction. Our results found statistical significance in comparison of both forceps under relative pain score, patient satisfaction and soft tissue healing post extraction.', 'detailedDescription': 'Abstract\n\n* INTRODUCTION/ BACKGROUND Tooth extractions are commonly done with conventional forceps. Recent advances like physics forceps help in atraumatic extractions by preserving the buccal plate, having less pain and better gingival healing. The buccal portion of the forceps is a plastic covered bumper which prevents reflection of buccal gingiva and buccal plate fracture. This is the first such comparison study to measure gingival healing in mandibular molar region with D2 bone quality.\n* OBJECTIVE To compare the efficacy of Physics Forceps and Conventional Forceps in extraction of mandibular molars by randomly dividing the patients in two groups. The efficacy is determined by comparing the success of extraction, relative pain score, incidence of alveolar fracture, patient satisfaction and soft tissue healing on 3rd post-operative day.\n* METHODOLOGY Patients who were indicated for extraction were included in the study. They were divided into two groups of 10 by double blinded randomization. Local Anesthesia was administered and the extraction was carried out using either Physics or Conventional forceps. Post extraction, the pain score was assessed using the VAS. Along with these, the gingival healing, success of extraction and alveolar plate fracture was assessed by the subject expert on the 3rd day post-operative day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18-55 years\n* Mandibular molar teeth indicated for extractions with gingival index 1.\n\nExclusion Criteria:\n\n* Patients with uncontrolled systemic diseases, that compromise dental extraction\n* Mandibular 3rd Molars\n* Grade 2 and 3 mobile teeth\n* Grossly decayed mandibular molars'}, 'identificationModule': {'nctId': 'NCT04875650', 'briefTitle': 'Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars', 'organization': {'class': 'OTHER', 'fullName': 'Melaka Manipal Medical College'}, 'officialTitle': 'Comparison of Physics Forceps and Conventional Forceps in Extraction of Mandibular Molars: A Double-Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MMMC/FOD/AR/B8/E C-2020 (01)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physics Forceps', 'interventionNames': ['Procedure: Extraction of Mandibular Molar using Physics Forceps']}, {'type': 'OTHER', 'label': 'Conventional Forcep', 'interventionNames': ['Procedure: Extraction of Mandibular Molar using Conventional Forceps']}], 'interventions': [{'name': 'Extraction of Mandibular Molar using Physics Forceps', 'type': 'PROCEDURE', 'description': 'Extraction of mandibular molars using physics forceps', 'armGroupLabels': ['Physics Forceps']}, {'name': 'Extraction of Mandibular Molar using Conventional Forceps', 'type': 'PROCEDURE', 'description': 'Extraction of mandibular molars using conventional forceps', 'armGroupLabels': ['Conventional Forcep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75150', 'city': 'Malacca', 'country': 'Malaysia', 'facility': 'Melaka Manipal Medical College', 'geoPoint': {'lat': 2.196, 'lon': 102.2405}}], 'overallOfficials': [{'name': 'Auric Bhattacharya, BDS, MDS, FICOI, MFDS, RCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melaka Manipal Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melaka Manipal Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Associate Professor', 'investigatorFullName': 'Auric Bhattacharya', 'investigatorAffiliation': 'Melaka Manipal Medical College'}}}}