CTRI/2024/04/065648Not yet recruitingPhase 3 4
Comparative assessment of efficiency and patient tolerance of hybrid arch bar, Erich’s arch bar and MMF screw placement in treatment of jaw fractures
Dr. D Y Patil dental college and hospital1 site in 1 country45 target enrollmentStarted: April 22, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Gingival inflammation
Study Overview
Brief Summary
A prospective randomized controlled clinical trial to be conducted on 45 patients with maxillofacial fractures requiring maxillomandibular fixation were split into 3 groups of 15 each. Patients in group A will be treated with Erich arch bar, patients in group B with MMF screws and patients in group C with hybrid arch bar. Factors to be assessed are gingival inflammation on day of removal and 7 days post removal of MMF appliance using modified gingival index, time taken for placement and removal in minutes and patient discomfort using visual analog scale.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with maxillofacial fractures requiring maxillomandibular fixation.
Exclusion Criteria
- •Patients with comminuted fractures of factial bones.
- •parhological fractures, edentulous ridges.
- •Patients with metabolic disorders, bleeding disorders, history of radiotherapy or chemotherapy.
Outcomes
Primary Outcomes
Gingival inflammation
Time Frame: 4 weeks post operative and 5 weeks post operative
Secondary Outcomes
- Time taken for application of MMF appliance(Day 0)
- Time taken for removal of MMF appliance(4 weeks Post op)
- Patient discomfort(4 weeks post op)
Investigators
CSSherwin Samuel
Dr. D Y Patil dental college and hospital
Study Sites (1)
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