Evaulation of treatment results in babies with split in the lip and roof of the mouth using 3D scans of the face and 3D replicas of the upper jaw.
Phase 2
- Conditions
- Health Condition 1: Q375- Cleft hard and soft palate with unilateral cleft lip
- Registration Number
- CTRI/2023/11/059389
- Lead Sponsor
- Dr Sanjana Mathur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
i. Complete unilateral cleft lip and palate.
ii.Un-operated babies.
iii.Age group from 7 days to less than 42 days.
Exclusion Criteria
i.Syndromic, malnourished and babies with systemic diseases.
ii.Patients/guardians who are not willing to go through the procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate and analyze treatment outcomes in the alveolar arches and facial soft tissues after Presurgical Nasoalveolar Molding using Modified Grayson Technique.Timepoint: Pre PNAM- T0 <br/ ><br>Post PNAM- T1(24 Weeks) <br/ ><br>1-month post lip repair- T2 <br/ ><br>6-month post lip repair- T3 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Clinically there is a significant difference in the facial dimensions & alveolar arches of the patient 1-month and 6-month post lip repair.Timepoint: 1year