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Completed

NCT Number: NCT06494098

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

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.

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Key information

Conditions

Cleft Lip and/or Palate Cleft Lip Bilateral Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

2 week–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakahliya, 35511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Syndromic patients.
  • Medically compromised patients contradicting operation.

Treatment and study plan

Nasoalveolar Molding

Procedure

presurgical orthopedics

Addition silicone impression

Diagnostic Test

diagnostic impression for maxillary arch and nose

Primary outcomes

  1. Attaining columellar length

    Time frame: 3 month

    the length of columella has increased after nasoalveolar molding orthopedic treatment

Secondary outcomes

  1. Treatment Duration

    Time frame: 3 month

    the time taken to decrease the alveolar cleft gap and to lengthen the columella

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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