NCT05467618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 18, 2022

Last Update Submit

July 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Indication of post-surgical infections

    Redness, swelling, pain, bleeding, or any discharge

    Up to three weeks

  • 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).

    Up to three weeks

Study Arms (2)

Intra-Oral Surgical approach

EXPERIMENTAL

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

Procedure: Maxillofacial surgery

Extra-Oral Surgical approach

EXPERIMENTAL

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

Procedure: Maxillofacial surgery

Interventions

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

Extra-Oral Surgical approachIntra-Oral Surgical approach

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayub Teaching Hospital

Abbottābād, Khyber Pakhtunkhwa, 22010, Pakistan

Location

Related Publications (12)

  • 1. Abbas I, Ali K. Management of mandibular fractures a prospective study; Pak Oral Dent 2007;22:151-2.

    BACKGROUND
  • 2. Muzzafar K. Management of maxillofacial trauma. AFID Dent J 2008;10:18-21.

    BACKGROUND
  • 3. Nayyak MS, Ekanayake MBK. Assessment of maxillofacial injuries. Pakistan Oral Dent J 2007;21:12-8.

    BACKGROUND
  • 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.

    PMID: 14552240BACKGROUND
  • 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.

    BACKGROUND
  • 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: 9532313BACKGROUND
  • 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.

    PMID: 8179524BACKGROUND
  • 8. Patel MF. Fixation techniques & mandibular osteosynthesis. In: Langdon JD, Patel MF. Operative maxillofacial surgery. 1st ed London: Chapman & Hall, 2005;331-45.

    BACKGROUND
  • 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: 8861293BACKGROUND
  • 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.

    PMID: 10716108BACKGROUND
  • 11. Risdon F: Ankylosis of Temporomandibular Joint. J Am Dent Assoc 2008; 21:1933.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Fractures, BoneMandibular Fractures

Interventions

Surgery, Oral

Condition Hierarchy (Ancestors)

Wounds and InjuriesJaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull Fractures

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Alman Khan, BDS,FCPS

    Ayub Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial with non-probability consecutive sampling.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 20, 2022

Study Start

March 1, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

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.

Locations