Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture
Primary Purpose
Fractures, Bone, Mandibular Fractures
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Maxillofacial surgery
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Bone
Eligibility Criteria
Inclusion Criteria:
- Patient aged 16 to 60 years
- Both Genders.
- Patients undergoing surgery for mandibular angle fracture
Exclusion Criteria:
- Pathological fractures.
- Condylar and sub-condylar fractures.
- Edentulous patients.
- Fire arm injury (FAI).
- Fractures of the middle third of face.
Sites / Locations
- Ayub Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intra-Oral Surgical approach
Extra-Oral Surgical approach
Arm Description
The mandibular fracture was reduced using an intra-oral surgical approach.
An External/Facial approach was used to reduce the mandibular bone fracture.
Outcomes
Primary Outcome Measures
Indication of post-surgical infections
Redness, swelling, pain, bleeding, or any discharge
Limited jaw opening
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05467618
First Posted
July 18, 2022
Last Updated
July 19, 2022
Sponsor
Ayub Teaching Hospital
Collaborators
Université Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT05467618
Brief Title
Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture
Official Title
Comparison of Intra-oral and Extra-oral Surgical Approach in Reducing Fractures at the Angle of the Mandible
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ayub Teaching Hospital
Collaborators
Université Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone, Mandibular Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial with non-probability consecutive sampling.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intra-Oral Surgical approach
Arm Type
Experimental
Arm Description
The mandibular fracture was reduced using an intra-oral surgical approach.
Arm Title
Extra-Oral Surgical approach
Arm Type
Experimental
Arm Description
An External/Facial approach was used to reduce the mandibular bone fracture.
Intervention Type
Procedure
Intervention Name(s)
Maxillofacial surgery
Intervention Description
An incision on the skin over the mandible versus incision on the gingivae inside the mouth
Primary Outcome Measure Information:
Title
Indication of post-surgical infections
Description
Redness, swelling, pain, bleeding, or any discharge
Time Frame
Up to three weeks
Title
Limited jaw opening
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).
Time Frame
Up to three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 16 to 60 years
Both Genders.
Patients undergoing surgery for mandibular angle fracture
Exclusion Criteria:
Pathological fractures.
Condylar and sub-condylar fractures.
Edentulous patients.
Fire arm injury (FAI).
Fractures of the middle third of face.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alman Khan, BDS,FCPS
Organizational Affiliation
Ayub Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayub Teaching Hospital
City
Abbottābād
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22010
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan 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.
Citations:
Citation
1. Abbas I, Ali K. Management of mandibular fractures a prospective study; Pak Oral Dent 2007;22:151-2.
Results Reference
background
Citation
2. Muzzafar K. Management of maxillofacial trauma. AFID Dent J 2008;10:18-21.
Results Reference
background
Citation
3. Nayyak MS, Ekanayake MBK. Assessment of maxillofacial injuries. Pakistan Oral Dent J 2007;21:12-8.
Results Reference
background
PubMed Identifier
14552240
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.
Results Reference
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.
Results Reference
background
PubMed Identifier
9532313
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.
Results Reference
background
PubMed Identifier
8179524
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.
Results Reference
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.
Results Reference
background
PubMed Identifier
8861293
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.
Results Reference
background
PubMed Identifier
10716108
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.
Results Reference
background
Citation
11. Risdon F: Ankylosis of Temporomandibular Joint. J Am Dent Assoc 2008; 21:1933.
Results Reference
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.
Results Reference
background
Learn more about this trial
Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture
We'll reach out to this number within 24 hrs