Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures
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|ClinicalTrials.gov Identifier: NCT03494309|
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mandibular Fractures||Procedure: Open Reduction & Internal Fixation Procedure: Closed Reduction & External Fixation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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"
- 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.
- Complications [ Time Frame: 6 months ]The frequency of complications with either mode of treatment shall be recorded
- 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.
- 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).