closure of defect between teeth in cleft patient by custom made distractor appliance.
Phase 2
Completed
- Conditions
- Health Condition 1: Q371- Cleft hard palate with unilateralcleft lipHealth Condition 2: Q35-Q37- Cleft lip and cleft palateHealth Condition 3: Q379- Unspecified cleft palate with unilateral cleft lip
- Registration Number
- CTRI/2018/09/015599
- Lead Sponsor
- Central of council and Industrial Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
Inclusion Criteria
1.Subjects with large alveolar cleft of size greater than width of canine after alignment and expansion.
2.Subjects with failure of attempted secondary alveolar bone grafting irrespective of size of defect.
Exclusion Criteria
Small alveolar defect less than the width of canine i.e. 9 mm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)PHASE 1- <br/ ><br>a.Case preparation for maxillary alveolar transport distraction. <br/ ><br>b)PHASE 2- <br/ ><br>a.Surgical procedure and closure of alveolar cleft defect by transport distraction <br/ ><br>c)PHASE 3- <br/ ><br>a.Assessment of closure of cleft defect post distraction <br/ ><br>b.Evaluation of pre and post distraction records for quantifying the closure of defect, movement of transport discs and anchorage unit. <br/ ><br>Timepoint: Assessment using radiovisuogram, lateral cephalogram and orthopantomogram in March 2019 followed by further evaluation in September 2019 <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Assessment for closure of residual defect by Bone graftingTimepoint: Assessment using radiovisuogram in October 2019.