Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures
Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
1 other identifier
interventional
70
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
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
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2015
CompletedFirst Submitted
Initial submission to the registry
March 24, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedApril 11, 2018
April 1, 2018
1 year
March 24, 2018
April 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mouth Opening
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"
6 months
Occlusion
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.
6 months
Secondary Outcomes (3)
Complications
6 months
Cost-Effectiveness
6 months
Patient Satisfaction
6 months
Study Arms (2)
ORIF
EXPERIMENTALOpen Reduction \& Internal Fixation
CREF
ACTIVE COMPARATORClosed Reduction \& External Fixation
Interventions
Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
Patients underwent closed reduction of the fracture and external fixation by arch bars \& guided elastics
Eligibility Criteria
You may qualify if:
- Age 16-60 years
- Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Oral & Maxillofacial Surgery
Study Record Dates
First Submitted
March 24, 2018
First Posted
April 11, 2018
Study Start
November 1, 2014
Primary Completion
November 15, 2015
Study Completion
November 15, 2015
Last Updated
April 11, 2018
Record last verified: 2018-04