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

Qualitative and Quantitative Comparative Evaluation of treatment of Unilateral Cleft Defect of the Lip and Palate using a 3D Printed Passive Pressure Plate and the Nasoalveolar Moulding Device – A Randomised Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056754

Enrollment

Registered

2023-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q371- Cleft hard palate with unilateralcleft lip Health Condition 2: K069- Disorder of gingiva and edentulousalveolar ridge, unspecified

Interventions

Intervention1: 3D printed Passive Presurgical infant orthopedic plate: To 3D print a plate using acrylic resin material after taking an intraoral scan for the infant. Control Intervention1: Active pre

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Neonates with bi-lateral cleft defect. 2.Above the age of 3 months. 3. Severe systematic illness.

Design outcomes

Primary

Measure	Time frame
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) 2. To check the changes in cleft width , cleft area, height of the palatal surface. 2. To measure the periodic weight gain of the baby , in both groups . Timepoint: initial, 1.5 months, 3 months	—

Secondary

Measure	Time frame
3. Aesthetic results obtained following surgical approximation. 4 The ease of the surgeon to approximate the 2 segments 5. The ease for the mother/caregiver to re-place the device & during breast feedingTimepoint: initial, 1.5 months , 3 months	—

Countries

India

Contacts

Public ContactDr Aravind Kumar Subramanian

Saveetha Dental coillege and hospital

aravindkumar@saveetha.com9841299939

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026