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Clinical Trials/CTRI/2024/08/072635
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

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Raparthy Bhuvan Chandra

Saveetha Dental College and Hospitals

Study Sites (1)

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