A comparison between 2 different treatment methods to treat infants affected by a genetic defect called cleft lip and palate
Phase 1
- Conditions
- Health Condition 1: Q371- Cleft hard palate with unilateralcleft lipHealth Condition 2: K069- Disorder of gingiva and edentulousalveolar ridge, unspecified
- Registration Number
- CTRI/2023/08/056754
- Lead Sponsor
- iharika Bhatia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Neonates with a complete unilateral cleft of the lip and palate
2.Under the age of 3 months.
3.Neonates with no neuromuscular disorder
Exclusion Criteria
1.Neonates with bi-lateral cleft defect.
2.Above the age of 3 months.
3. Severe systematic illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To measure the total volume of the cleft defect using the 3D software as measured in the base article at 3 different times – start , after 1 months, before surgery) <br/ ><br> <br/ ><br>2. To check the changes in cleft width , cleft area, height of the palatal surface. <br/ ><br> <br/ ><br>2. To measure the periodic weight gain of the baby , in both groups . <br/ ><br> <br/ ><br>Timepoint: initial, 1.5 months, 3 months <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 3. Aesthetic results obtained following surgical approximation. <br/ ><br> <br/ ><br>4 The ease of the surgeon to approximate the 2 segments <br/ ><br> <br/ ><br>5. The ease for the mother/caregiver to re-place the device & during breast feedingTimepoint: initial, 1.5 months , 3 months