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

NCT ID: NCT06494098

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-16

Study Completion Date

2024-09-15

Brief Summary

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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

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Conditions

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Cleft Lip and/or Palate Cleft Lip Bilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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NAM group

Group Type EXPERIMENTAL

Nasoalveolar Molding

Intervention Type PROCEDURE

presurgical orthopedics

Addition silicone impression

Intervention Type DIAGNOSTIC_TEST

diagnostic impression for maxillary arch and nose

MNAM

Group Type EXPERIMENTAL

Nasoalveolar Molding

Intervention Type PROCEDURE

presurgical orthopedics

Addition silicone impression

Intervention Type DIAGNOSTIC_TEST

diagnostic impression for maxillary arch and nose

Interventions

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Nasoalveolar Molding

presurgical orthopedics

Intervention Type PROCEDURE

Addition silicone impression

diagnostic impression for maxillary arch and nose

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mansoura University

Al Mansurah, Dakahliya, Egypt

Site Status

Countries

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Egypt

Related Links

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Other Identifiers

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M02204023PP

Identifier Type: -

Identifier Source: org_study_id

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