Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture

Sponsor
Ayub Teaching Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05467618
Collaborator
Université Montpellier (Other)
360
1
2
6
59.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Maxillofacial surgery
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised controlled trial with non-probability consecutive sampling.Randomised controlled trial with non-probability consecutive sampling.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Intra-oral and Extra-oral Surgical Approach in Reducing Fractures at the Angle of the Mandible
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Aug 31, 2017
Actual Study Completion Date :
Aug 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intra-Oral Surgical approach

The mandibular fracture was reduced using an intra-oral surgical approach.

Procedure: Maxillofacial surgery
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.

Procedure: Maxillofacial surgery
An incision on the skin over the mandible versus incision on the gingivae inside the mouth

Outcome Measures

Primary Outcome Measures

  1. Indication of post-surgical infections [Up to three weeks]

    Redness, swelling, pain, bleeding, or any discharge

  2. Limited jaw opening [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ayub Teaching Hospital Abbottābād Khyber Pakhtunkhwa Pakistan 22010

Sponsors and Collaborators

  • Ayub Teaching Hospital
  • Université Montpellier

Investigators

  • Principal Investigator: Alman Khan, BDS,FCPS, Ayub Teaching Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shahid ali shah, Assistant Professor, Ayub Teaching Hospital
ClinicalTrials.gov Identifier:
NCT05467618
Other Study ID Numbers:
  • sashah0001
First Posted:
Jul 20, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022