Mandibular FracturesNCT03494309
Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures
A study testing Open Reduction & Internal Fixation and Closed Reduction & External Fixation in people with Mandibular Fractures, run by King Edward Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Open Reduction & Internal Fixation and Closed Reduction & External Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 15 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-60 years
- Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.
Who cannot join
- 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
About this study
Official title: Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
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.
- Conditions
- Mandibular Fractures
- Being tested
- Open Reduction & Internal Fixation, Closed Reduction & External Fixation
- Keywords
- Mandibular Subcondylar Fractures, Mouth Opening, Open Reduction and Internal Fixation, Closed Reduction with External Fixation
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction & Internal FixationProcedure or surgery
Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
Closed Reduction & External FixationProcedure or surgery
Patients underwent closed reduction of the fracture and external fixation by arch bars \& guided elastics
| Study group | Role | What they receive |
|---|---|---|
| ORIF | Experimental | Open Reduction \& Internal Fixation Receives: Procedure: Open Reduction & Internal Fixation |
| CREF | Active comparator | Closed Reduction \& External Fixation Receives: Procedure: Closed Reduction & External Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
Complications
The frequency of complications with either mode of treatment shall be recorded
Measured: 6 months
Cost-Effectiveness
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.
Measured: 6 months
Patient Satisfaction
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Nov 2014
- Primary completion15 Nov 2015
- Study completion15 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira S Baloch, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494309
- Sponsor's protocol ID
- 107/RC/KEMU
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
- ClinicalTrials.gov ID
- NCT03494309
- Acronym / sponsor ID
- 107/RC/KEMU
- Conditions
- Mandibular Fractures
- Keywords
- Mandibular Subcondylar Fractures, Mouth Opening, Open Reduction and Internal Fixation, Closed Reduction with External Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 15 Nov 2015 (actual)
- Study completion
- 15 Nov 2015 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORIF | Experimental | Procedure: Open Reduction & Internal FixationOpen Reduction \& Internal Fixation |
| CREF | Active comparator | Procedure: Closed Reduction & External FixationClosed Reduction \& External Fixation |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 16-60 years
- Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.
Key exclusion criteria (6 listed)
- Bilateral MCFs
- MCF with mid-facial fractures
- Insufficient bilateral dentition
- Medically unfit for surgery
- Old healed mandibular fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Reduction & Internal FixationPatients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws | Procedure or surgery | ORIF |
| Closed Reduction & External FixationPatients underwent closed reduction of the fracture and external fixation by arch bars \& guided elastics | Procedure or surgery | CREF |
Primary outcome
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.
3 secondary outcomes
Complications
Time frame: 6 months
Cost-Effectiveness
Time frame: 6 months
Patient Satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction & Internal Fixation and Closed Reduction & External Fixation in people with Mandibular Fractures, run by King Edward Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth Opening (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.