CTRI/2024/08/072635
Not yet recruiting
Phase 3
Comparison of Skeletal Stability between Single-plate osteosynthesis and double-plate osteosynthesis in anterior mandibular osteotomies -A randomised clinical trial
saveetha dental college and hospitals1 site in 1 country26 target enrollmentStarted: August 24, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- skeletal stability with cephalometric landmarks, at immediate post op and 6 months postbop
Overview
Brief Summary
The present randomized control trial aims to fill this void in literature by comparing the quantitative treatment outcome like skeletal stability achieved by using the traditional method of double plate osteosynthesis and a relatively new technique of single plate osteosynthesis in anterior mandibular osteotomies.
No available literature reports a comparison between the aforementioned techniques, making this trial a novel idea.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 15.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •The study includes subjects aged 18 to 50, male or female, requiring anterior mandibular osteotomies (subapical osteotomies and genioplasties) for correction of skeletal mandibular deformities, and systematically healthy individuals.
Exclusion Criteria
- •Subjects with known systemic diseases, subjects who are mentally challenged, pregnant women, and lactating women.
- •Patients undergoing genial corrections in transverse directions for facial asymmetry correction.
- •Patients with cleft and craniofacial syndromes.
Outcomes
Primary Outcomes
skeletal stability with cephalometric landmarks, at immediate post op and 6 months postbop
Time Frame: preop , immediate post op, 6 months post op
Secondary Outcomes
- neuromuscular disturbances(ease of surgery)
Investigators
Raparthy Bhuvan Chandra
Saveetha Dental College and Hospitals
Study Sites (1)
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