A comparison between 2 different treatment methods to treat infants affected by a genetic defect called cleft lip and palate

Phase 1/2

Not yet recruiting

Conditions: Cleft hard palate with unilateralcleft lip, (2) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,

Brief Summary: PARTICIPANTS ARE SCREENED AND CHECKED TOFIT INTO THE INCLUSION CRITERIA. A SAMPLE SIZE OF 14 PATIENTS IS SELECTED WITH THE COMPLETE UNILATERAL CLEFT OF THE LIP AND PALATE and are randomly divided into 2 groups. Group 1: included those patients who will be treated by a passive presurgical infant orthopedic plate- or the 3-D printed passive pressure plate, while Group 2 included those patients to be treated with active presurgical infant orthopedics ie. conventional nasoalveolar molding device.

All the children falling under both these groups will be evaluated based on 3D intraoral scans that will be taken using a common intraoral scanner, at 3-time intervals - initial (pre-treatment scan ), after 1.5 months and at 3 months.

The main outcomes that will be assessed will fall into two broad categories: Quantitative and Qualitative assessment.

The volumetric and area analysis of the cleft defect will be assessed using the 3D software and compared for both groups for a comparative evaluation, to sess the effectiveness of both the methods of presurgical infant orthopedics.

Recruitment & Eligibility

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

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 â€“ start , after 1 months, before surgery)	initial, 1.5 months, 3 months
2. To check the changes in cleft width , cleft area, height of the palatal surface.	initial, 1.5 months, 3 months
2. To measure the periodic weight gain of the baby , in both groups .	initial, 1.5 months, 3 months

Secondary Outcome Measures

Name	Time	Method
3. Aesthetic results obtained following surgical approximation.	4 The ease of the surgeon to approximate the 2 segments

Locations (1): Saveetha Dental College and Hospital
🇮🇳
Chennai, TAMIL NADU, India
Saveetha Dental College and Hospital
🇮🇳Chennai, TAMIL NADU, India
Niharika bhatia
Principal investigator
9711121996
152108007.sdc@saveetha.com