Conventional Versus Modified Pre-surgical Naso-Alveolar Molding Treatment in Cleft Lip and Palate Infants

Mansoura University

Status: Completed

Conditions: Cleft Lip and/or Palate; Cleft Lip Bilateral

Treatments: Diagnostic Test: Addition silicone impression; Procedure: Nasoalveolar Molding

Study type: Interventional

Funder types: Other

Identifiers

NCT06494098

M02204023PP

Details and patient eligibility

About

The aim of this study is to evaluate and compare clinically conventional Pre-surgical Naso-Alveolar Molding (PNAM) treatment versus Modified Naso-Alveolar Molding protocol (MPNAM) in cleft lip and palate patients in terms of:

1. Decreasing cleft gap.
2. Attaining columellar length.
3. Effect on maxillary growth.
4. Treatment Duration.
5. Parents acceptance.

Enrollment: 20 patients

Sex: All

Ages: 2 weeks to 2 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The age range from 14 -30 days after birth.
2. Has complete cleft lip and palate.
3. Parents acceptance.
4. Medically free infants.

Exclusion criteria

1. Syndromic patients.
2. Medically compromised patients contradicting operation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

NAM group

Experimental group

Treatment:

Procedure: Nasoalveolar Molding

Diagnostic Test: Addition silicone impression

MNAM

Experimental group

Treatment:

Procedure: Nasoalveolar Molding

Diagnostic Test: Addition silicone impression