CClinicalTrials.gg
CompletedNCT05467618Updated Jul 20, 2022

Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture

An interventional study of Maxillofacial surgery in Fractures, Bone and Mandibular Fractures, sponsored by Ayub Teaching Hospital. Completed at 1 site in Pakistan. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Ayub Teaching Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 4 months after the study started (first participant enrolled Mar 2017, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fractures, Bone
  • Mandibular Fractures
03

In context

Mandibular Fractures

81 studies on the registry are indexed under Mandibular Fractures; 20 are open to participants now.

This study's enrollment of 360 is above the median of 22 across 62 interventional studies indexed under Mandibular Fractures.

Browse Mandibular Fractures studies →

Lead sponsor

Ayub Teaching Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient aged 16 to 60 years
  • Both Genders.
  • Patients undergoing surgery for mandibular angle fracture

Exclusion criteria

Exclusion Criteria:

  • Pathological fractures.
  • Condylar and sub-condylar fractures.
  • Edentulous patients.
  • Fire arm injury (FAI).
  • Fractures of the middle third of face.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (actual)

Study arms

  • Experimental
    Intra-Oral Surgical approach

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

    Procedure: Maxillofacial surgery

  • Experimental
    Extra-Oral Surgical approach

    An External/Facial approach was used to reduce the mandibular bone fracture.

    Procedure: Maxillofacial surgery

Interventions

  • ProcedureMaxillofacial surgery

    An incision on the skin over the mandible versus incision on the gingivae inside the mouth

06

What researchers measure

Primary outcomes

  1. Indication of post-surgical infections

    Redness, swelling, pain, bleeding, or any discharge

    Time frame: Up to three weeks

  2. 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).

    Time frame: Up to three weeks

07

Study locations

1 site
  • Ayub Teaching Hospital
    Abbottābād, Khyber Pakhtunkhwa 22010, Pakistan
08

References and documents

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. PubMed 14552240 ↗
  • 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. PubMed 9532313 ↗
  • 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. PubMed 8179524 ↗
  • 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. PubMed 8861293 ↗
  • 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. PubMed 10716108 ↗
  • 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.

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05467618
Lead sponsor
Ayub Teaching Hospital
Collaborators
Université Montpellier
Responsible party
Shahid ali shah (Assistant Professor, Ayub Teaching Hospital) — Principal investigator
First posted
Jul 20, 2022
Start date
Mar 1, 2017
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017
Last update
Jul 20, 2022

Study contacts

Alman Khan, BDS,FCPS
principal investigator · Ayub Teaching Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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