CTRI/2022/07/043920Not yet recruitingNot Applicable
‘‘Comparative study to evaluate the occurrence of nonunion/malunion in the double mandibular fracture patients who are treated with one load bearing fixation in anterior fracture and one load sharing fixation in posterior fracture vs two load sharing fixation – Randomized controlled trialâ€
KISHORE M S1 site in 1 country30 target enrollmentStarted: July 15, 2022Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Non-union
Study Overview
Brief Summary
This is a clinical trial to compare and evaluate the occurrence of nonunion and malunion in double mandibular fracture patients who are treated with one load bearing fixation in anterior fracture and one load sharing fixation in posterior fracture vs two load sharing fixation. The primary outcome measure will be occurrence of nonunion at the time of followup.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with double mandibular fracture.
Exclusion Criteria
- •Edentulous patients with atrophic mandible, Patients with condyle, coronoid or ramus fracture, Patients having fracture with bone loss who need bone graft, Infected mandibular fractures, Comminuted mandibular fractures,Patients with old mandibular fractures who requires surgery for residual deformities >8 wecks from time of trauma ).
- •Pan facial trauma/associated maxillary fracture requiring postoperative I.
Outcomes
Primary Outcomes
Non-union
Time Frame: non-union will be assessed after 10 weeks of placement
Secondary Outcomes
- Pain and infection(after 10 weeks of placement of the plates)
Investigators
Study Sites (1)
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