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

Not Applicable

Active, not recruiting

• Conditions: Cleft Lip and/or Palate; Cleft Lip Bilateral
• Interventions: Procedure: Nasoalveolar Molding; Diagnostic Test: Addition silicone impression

• Registration Number: NCT06494098
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2024-06-16
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAM group	Addition silicone impression	-
MNAM	Addition silicone impression	-
MNAM	Nasoalveolar Molding	-
NAM group	Nasoalveolar Molding	-

Primary Outcome Measures

Name	Time	Method
Attaining columellar length	3 month

Secondary Outcome Measures

Name	Time	Method
Treatment Duration	3 month

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Dakahliya, Egypt