- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05467618
Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture
July 19, 2022 updated by: Shahid ali shah, Ayub Teaching Hospital
Comparison of Intra-oral and Extra-oral Surgical Approach in Reducing Fractures at the Angle of the Mandible
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Khyber Pakhtunkhwa
-
Abbottābād, Khyber Pakhtunkhwa, Pakistan, 22010
- Ayub Teaching Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intra-Oral Surgical approach
The mandibular fracture was reduced using an intra-oral surgical approach.
|
An incision on the skin over the mandible versus incision on the gingivae inside the mouth
|
EXPERIMENTAL: Extra-Oral Surgical approach
An External/Facial approach was used to reduce the mandibular bone fracture.
|
An incision on the skin over the mandible versus incision on the gingivae inside the mouth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Indication of post-surgical infections
Time Frame: Up to three weeks
|
Redness, swelling, pain, bleeding, or any discharge
|
Up to three weeks
|
Limited jaw opening
Time Frame: Up to three weeks
|
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).
|
Up to three weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alman Khan, BDS,FCPS, Ayub Teaching Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 1. Abbas I, Ali K. Management of mandibular fractures a prospective study; Pak Oral Dent 2007;22:151-2.
- 2. Muzzafar K. Management of maxillofacial trauma. AFID Dent J 2008;10:18-21.
- 3. Nayyak MS, Ekanayake MBK. Assessment of maxillofacial injuries. Pakistan Oral Dent J 2007;21:12-8.
- 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.
- 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.
- 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.
- 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.
- 8. Patel MF. Fixation techniques & mandibular osteosynthesis. In: Langdon JD, Patel MF. Operative maxillofacial surgery. 1st ed London: Chapman & Hall, 2005;331-45.
- 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.
- 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.
- 11. Risdon F: Ankylosis of Temporomandibular Joint. J Am Dent Assoc 2008; 21:1933.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2017
Primary Completion (ACTUAL)
August 31, 2017
Study Completion (ACTUAL)
August 31, 2017
Study Registration Dates
First Submitted
July 18, 2022
First Submitted That Met QC Criteria
July 19, 2022
First Posted (ACTUAL)
July 20, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sashah0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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