Comparative evaluation of skeletal and dental changes following mandibular en masse distalization with buccal shelf screws - A randomised controlled trial between two orthodontic mechanics
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Nisshitha Rao Setvaji
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Linear (mm) and angular (degrees) skeletal and dental changes
Overview
Brief Summary
A comparative evaluation of skeletal and dental changes following mandibular en masse distalization with buccal shelf screws - A randomised controlled trial between two orthodontic mechanics
Aim: To compare and evaluate the skeletal and dental changes following lower en masse distalization with buccal shelf screws between two orthodontic mechanics
Sample size: 18 patients
Randomised controlled clinical trial
Group 1: Distalization with a statically determinate system
Group 2: Distalization with a statically indeterminate system
Methodology: Linear and angular skeletal and dental changes calculated between the pre distalization and post distalization CBCT values.
The rate of lower molar distlization to be calculated by dividing the amount of distalization by the time taken to achieve Angle’s Class l molar relationship.
Primary and secondary parameters to be measured from the pre and post distalization CBCTs and the difference between the two orthodontic biomechanics to be calculated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 14.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Class lll skeletal and dental relationships of all growth patterns Extracted lower third molars No other missing or extracted teeth.
Exclusion Criteria
- •Subjects with Class l and ll skeletal and dental relationships were excluded.
- •Subjects with facial asymmetry or asymmetrical arches were excluded.
- •Subjects with missing teeth or functional deviations on occlusion were excluded.
- •Subjects with craniofacial syndromes or physically or mentally handicapped were excluded.
Outcomes
Primary Outcomes
Linear (mm) and angular (degrees) skeletal and dental changes
Time Frame: Baseline, 5 months and 10 months (end of distalization).
Secondary Outcomes
- Rate of mandibular arch distalization, anterior & posterior anatomical limits, soft tissue changes, tongue position, hyoid position & airway volume changes(Baseline, 5 months & 10 months (end of distalization))
Investigators
Nisshitha Rao Setvaji
Saveetha Institute of Medical and Technical Sciences