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

NCT06494098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-11

No results posted yet for this study

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.

Conditions

  • Cleft Lip and/or Palate
  • Cleft Lip Bilateral

Interventions

PROCEDURE

Nasoalveolar Molding

presurgical orthopedics

DIAGNOSTIC_TEST

Addition silicone impression

diagnostic impression for maxillary arch and nose

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-16
Primary Completion
2024-09-01
Completion
2024-09-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06494098 on ClinicalTrials.gov