NCT06494098

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. 1.Decreasing cleft gap.
  2. 2.Attaining columellar length.
  3. 3.Effect on maxillary growth.
  4. 4.Treatment Duration.
  5. 5.Parents acceptance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

May 11, 2025

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

July 2, 2024

Last Update Submit

May 6, 2025

Conditions

Cleft Lip and/or PalateCleft Lip Bilateral

Keywords

Cleft palateCleft Lip and/or PalateNasoalveolar Molding

Outcome Measures

Primary Outcomes (1)

  • Attaining columellar length

    the length of columella has increased after nasoalveolar molding orthopedic treatment

    3 month

Secondary Outcomes (1)

  • Treatment Duration

    3 month

Study Arms (2)

NAM group

EXPERIMENTAL
Procedure: Nasoalveolar MoldingDiagnostic Test: Addition silicone impression

MNAM

EXPERIMENTAL
Procedure: Nasoalveolar MoldingDiagnostic Test: Addition silicone impression

Interventions

Nasoalveolar MoldingPROCEDURE

presurgical orthopedics

MNAMNAM group
Addition silicone impressionDIAGNOSTIC_TEST

diagnostic impression for maxillary arch and nose

MNAMNAM group

Eligibility Criteria

Age2 Weeks - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Syndromic patients.
  • Medically compromised patients contradicting operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahliya, 35511, Egypt

Location

Related Links

MeSH Terms

Conditions

Cleft Palate

Interventions

Nasoalveolar Molding

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Preoperative CarePerioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

June 16, 2024

Primary Completion

September 1, 2024

Study Completion

September 15, 2024

Last Updated

May 11, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)