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Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494309
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Samira S Baloch, King Edward Medical University

Brief Summary:
Patients with mandibular sub-condylar fractures underwent either either open reduction with internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to CREF.

Condition or disease Intervention/treatment Phase
Mandibular Fractures Procedure: Open Reduction & Internal Fixation Procedure: Closed Reduction & External Fixation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : November 15, 2015
Actual Study Completion Date : November 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: ORIF
Open Reduction & Internal Fixation
Procedure: Open Reduction & Internal Fixation
Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws

Active Comparator: CREF
Closed Reduction & External Fixation
Procedure: Closed Reduction & External Fixation
Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics




Primary Outcome Measures :
  1. Mouth Opening [ Time Frame: 6 months ]
    Mouth Opening shall be determined by measuring the maximal distance between the edges of upper and lower incisors with fully opened mouth; the measurement shall be made in millimeters (mm) using vernier caliper and mouth opening of 35 mm or more shall be classified as "adequate"

  2. Occlusion [ Time Frame: 6 months ]
    Occlusion shall be determined by maximum "inter-cuspation" as observed by the surgeon and patient self-reporting and will be classified as fine or deranged.


Secondary Outcome Measures :
  1. Complications [ Time Frame: 6 months ]
    The frequency of complications with either mode of treatment shall be recorded

  2. Cost-Effectiveness [ Time Frame: 6 months ]

    Cost-Effectiveness shall be determined as the ratio of the cost of treatment and achievement of both adequate mouth opening and fine occlusion.

    The cost of treatment shall include the cost of surgical items (wires, elastics, arch bars, plates, screws etc), cost of anesthesia and surgery, cost of hospital stay and cost of follow up.


  3. Patient Satisfaction [ Time Frame: 6 months ]

    Participants shall be requested to report their satisfaction after treatment with regards to ease of chewing, mouth opening & closing and achievement of pre0traumatic facial symmetry/orientation.

    This parameter shall be recorded on a 4-point Likert scale (not satisfied, somewhat dissatisfied, somewhat satisfied, satisfied).




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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 16-60 years
  • Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.

Exclusion Criteria:

  • Bilateral MCFs
  • MCF with mid-facial fractures
  • Insufficient bilateral dentition
  • Medically unfit for surgery
  • Old healed mandibular fractures
  • History of previous mandibular surgery for the same indication
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Responsible Party: Samira S Baloch, Assistant Professor of Oral & Maxillofacial Surgery, King Edward Medical University
ClinicalTrials.gov Identifier: NCT03494309    
Other Study ID Numbers: 107/RC/KEMU
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samira S Baloch, King Edward Medical University:
Mandibular Subcondylar Fractures
Mouth Opening
Open Reduction and Internal Fixation
Closed Reduction with External Fixation
Additional relevant MeSH terms:
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Mandibular Fractures
Fractures, Bone
Wounds and Injuries
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures