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

Mansoura University20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cleft Lip and/or Palate Cleft Lip Bilateral

Interventions

Nasoalveolar MoldingPROCEDURE

presurgical orthopedics

Addition silicone impressionDIAGNOSTIC_TEST

diagnostic impression for maxillary arch and nose

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 2 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mansoura University

Al Mansurah, Dakahliya, Egypt

Outcomes

Primary Outcomes

Attaining columellar length

the length of columella has increased after nasoalveolar molding orthopedic treatment

Time frame: 3 month

Secondary Outcomes

Treatment Duration

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

Time frame: 3 month

Data from ClinicalTrials.gov

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