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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06494098
Enrollment
20
Registered
2024-07-10
Start date
2024-06-16
Completion date
2024-09-15
Last updated
2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and/or Palate, Cleft Lip Bilateral

Keywords

Cleft palate, Cleft Lip and/or Palate, Nasoalveolar Molding

Brief 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.

Interventions

presurgical orthopedics

diagnostic impression for maxillary arch and nose

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Weeks to 2 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Attaining columellar length3 monththe length of columella has increased after nasoalveolar molding orthopedic treatment

Secondary

MeasureTime frameDescription
Treatment Duration3 monththe time taken to decrease the alveolar cleft gap and to lengthen the columella

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026