Conventional Versus Modified Pre-surgical Naso-Alveolar M... | NCT06494098

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

NCT06494098

Sponsor

Mansoura University

Status

Completed

Last Update Posted

May 11, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Cleft Lip and/or Palate
Cleft Lip Bilateral

Interventions

Nasoalveolar Molding
Addition silicone impression

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2024Actual

Primary Completion Date

Sep 1, 2024Actual

Completion Date

Sep 15, 2024Actual

First Submitted Date

Jul 2, 2024

First Submission Date that Met QC Criteria

Jul 2, 2024

First Posted Date

Jul 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2025

Last Update Posted Date

May 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

Decreasing cleft gap.
Attaining columellar length.
Effect on maxillary growth.
Treatment Duration.
Parents acceptance.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NAM group	Experimental		Procedure: Nasoalveolar Molding Diagnostic Test: Addition silicone impression
MNAM	Experimental		Procedure: Nasoalveolar Molding Diagnostic Test: Addition silicone impression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasoalveolar Molding	Procedure	presurgical orthopedics	MNAM NAM group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

2 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University		Al Mansurah	Dakahliya	35511	Egypt

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002972	Cleft Palate

Ancestor Terms

ID	Term
D007569	Jaw Abnormalities
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D019767	Maxillofacial Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000084982	Nasoalveolar Molding

Ancestor Terms

ID	Term
D011300	Preoperative Care
D019990	Perioperative Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided