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

May 6, 2025 updated by: Mansoura University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahliya
      • Mansoura, Dakahliya, Egypt, 35511
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAM group
Procedure: Nasoalveolar Molding
presurgical orthopedics
Diagnostic test: Addition silicone impression
diagnostic impression for maxillary arch and nose
Experimental: MNAM
Procedure: Nasoalveolar Molding
presurgical orthopedics
Diagnostic test: Addition silicone impression
diagnostic impression for maxillary arch and nose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attaining columellar length
Time Frame: 3 month
the length of columella has increased after nasoalveolar molding orthopedic treatment
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Duration
Time Frame: 3 month
the time taken to decrease the alveolar cleft gap and to lengthen the columella
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02204023PP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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