Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05467618
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2022-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D008337', 'term': 'Mandibular Fractures'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007572', 'term': 'Jaw Fractures'}, {'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013515', 'term': 'Surgery, Oral'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trial with non-probability consecutive sampling.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-19', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indication of post-surgical infections', 'timeFrame': 'Up to three weeks', 'description': 'Redness, swelling, pain, bleeding, or any discharge'}, {'measure': 'Limited jaw opening', 'timeFrame': 'Up to three weeks', 'description': 'Mouth opening considered limited if the patient can only open mouth to a width of less than the width of his/her three fingers (index, middle, ring).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fractures, Bone', 'Mandibular Fractures']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. Abbas I, Ali K. Management of mandibular fractures a prospective study; Pak Oral Dent 2007;22:151-2.'}, {'type': 'BACKGROUND', 'citation': '2. Muzzafar K. Management of maxillofacial trauma. AFID Dent J 2008;10:18-21.'}, {'type': 'BACKGROUND', 'citation': '3. Nayyak MS, Ekanayake MBK. Assessment of maxillofacial injuries. Pakistan Oral Dent J 2007;21:12-8.'}, {'pmid': '14552240', 'type': 'BACKGROUND', 'citation': 'Abbas I, Ali K, Mirza YB. Spectrum of mandibular fractures at a tertiary care dental hospital in Lahore. J Ayub Med Coll Abbottabad. 2003 Apr-Jun;15(2):12-4.'}, {'type': 'BACKGROUND', 'citation': '5. Zaki MA, Islam T, Mamon S, Aleem A. Pattern of maxillofacial injuries received at Abassi Shaheed Hospital, KMDC, Karachi. Annual Abassi Shaheed Hosp. 2008;7:291-3.'}, {'pmid': '9532313', 'type': 'BACKGROUND', 'citation': 'Lawoyin DO, Lawoyin JO, Lawoyin TO. Fractures of the facial skeleton in Tabuk North West Armed Forces Hospital: a five year review. Afr J Med Med Sci. 1996 Dec;25(4):385-7.'}, {'pmid': '8179524', 'type': 'BACKGROUND', 'citation': 'Edwards TJ, David DJ, Simpson DA, Abbott AA. Patterns of mandibular fractures in Adelaide, South Australia. Aust N Z J Surg. 1994 May;64(5):307-11. doi: 10.1111/j.1445-2197.1994.tb02216.x.'}, {'type': 'BACKGROUND', 'citation': '8. Patel MF. Fixation techniques & mandibular osteosynthesis. In: Langdon JD, Patel MF. Operative maxillofacial surgery. 1st ed London: Chapman & Hall, 2005;331-45.'}, {'pmid': '8861293', 'type': 'BACKGROUND', 'citation': 'Renton TF, Wiesenfeld D. Mandibular fracture osteosynthesis: a comparison of three techniques. Br J Oral Maxillofac Surg. 1996 Apr;34(2):166-73. doi: 10.1016/s0266-4356(96)90372-1.'}, {'pmid': '10716108', 'type': 'BACKGROUND', 'citation': 'Moreno JC, Fernandez A, Ortiz JA, Montalvo JJ. Complication rates associated with different treatments for mandibular fractures. J Oral Maxillofac Surg. 2000 Mar;58(3):273-80; discussion 280-1. doi: 10.1016/s0278-2391(00)90051-x.'}, {'type': 'BACKGROUND', 'citation': '11. Risdon F: Ankylosis of Temporomandibular Joint. J Am Dent Assoc 2008; 21:1933.'}, {'type': 'BACKGROUND', 'citation': '12. Ali S, Warraich A. Comparison of two surgical procedures in reduction of mandibular angle fracture. Pak oral Dent J. 2010;30(2):287-90.'}]}, 'descriptionModule': {'briefSummary': 'This study compared the surgical approach to the lower jaw fractures, an approach from the face and an approach from inside the mouth were used and compared for the outcomes.', 'detailedDescription': 'Mandibular factures tend to be more common than those of the middle third of the face.1 They occur alone or in combination with other facial bone fractures resulting in severe loss of function and disfigurement.2,3 Mandibular factures tend to be more common than those of the middle third of the face.1 They occur alone or in combination with other facial bone fractures resulting in severe loss of function and disfigurement.2,3 The pattern of mandibular fractures varies with geographic location, physical activity, social, cultural and environmental factors. The main causes 4,5 of mandibular fracture are; Road traffic accidents, interpersonal violence, falls, sports injuries, industrial trauma, pathological fractures etc. In developing countries road traffic accident 6 is the common cause of mandibular fractures due to lack of implementation of traffic laws while in developing countries alcohol related7 interpersonal violence is the leading cause. Any age and sex group may sustain trauma to the lower jaw but children below the age of 12 years are less susceptible to fracture because their bones are more resilient.5,6 Different modalities available for the treatment of mandibular fractures are: Maxillo mandibular fixation (MMF) alone e.g. dental wiring, arch bar etc.8 Previously traditional methods i.e. maxillomandibular fixation and transosseous wiring were the most popular methods used for mandibular fracture fixation. These are still commonly used methods9 and have got various disadvantages such as preventing normal jaw function, weight loss due to restriction of food to liquid consistency, oral hygiene problem and reduction of ventilatory volume.,10 Currently, fixation with one or two mini- plates has become a widely acceptable method of providing internal fixation and eliminating the need for post-operative maxillo mandibular fixation. The fixation of mandibular angle can be carried out by two methods i.e. Intra oral approach8, and Extra oral approach. For intra oral approach buccal sulcus incision while for extra oral approach sub-mandibular (Risdon),11 incision is given. Postoperative complications related to both types of treatment modalities were observed in intra oral approach 13.3 % and extra oral approach 16.6% infection and limited opening were observed in intra oral approach 6.6% and extra oral approach 16.6%.12 Rationale of this study is to compare post-operative complication of intra oral approach and extra oral approach in reduction of mandibular angle fracture in terms of infection and limited mouth opening. In our study, if we find less complication of intra-oral approach in significant number of patients, we will strongly recommend its routine use in the reduction of pain and limited mouth opening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 16 to 60 years\n* Both Genders.\n* Patients undergoing surgery for mandibular angle fracture\n\nExclusion Criteria:\n\n* Pathological fractures.\n* Condylar and sub-condylar fractures.\n* Edentulous patients.\n* Fire arm injury (FAI).\n* Fractures of the middle third of face.'}, 'identificationModule': {'nctId': 'NCT05467618', 'briefTitle': 'Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Ayub Teaching Hospital'}, 'officialTitle': 'Comparison of Intra-oral and Extra-oral Surgical Approach in Reducing Fractures at the Angle of the Mandible', 'orgStudyIdInfo': {'id': 'sashah0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-Oral Surgical approach', 'description': 'The mandibular fracture was reduced using an intra-oral surgical approach.', 'interventionNames': ['Procedure: Maxillofacial surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Extra-Oral Surgical approach', 'description': 'An External/Facial approach was used to reduce the mandibular bone fracture.', 'interventionNames': ['Procedure: Maxillofacial surgery']}], 'interventions': [{'name': 'Maxillofacial surgery', 'type': 'PROCEDURE', 'description': 'An incision on the skin over the mandible versus incision on the gingivae inside the mouth', 'armGroupLabels': ['Extra-Oral Surgical approach', 'Intra-Oral Surgical approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22010', 'city': 'Abbottābād', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Ayub Teaching Hospital'}], 'overallOfficials': [{'name': 'Alman Khan, BDS,FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ayub Teaching Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'These are walk-in patients to the facility and we are officially obligated to keep their confidentiality. The facility may be approached for the data and data maybe provided subject to the approval of the subjects.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayub Teaching Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Montpellier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Shahid ali shah', 'investigatorAffiliation': 'Ayub Teaching Hospital'}}}}