Effect of Different Nasal Stent Designs With Nasoalveolar... | NCT06411444

Studies
Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

NCT06411444

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

May 13, 2024Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Cleft Lip
Cleft Lip and Palate

Interventions

Grape Design Nasal Stent

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

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Estimated

Primary Completion Date

Apr 15, 2025Estimated

Completion Date

Apr 15, 2025Estimated

First Submitted Date

Apr 28, 2024

First Submission Date that Met QC Criteria

May 9, 2024

First Posted Date

May 13, 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 9, 2024

Last Update Posted Date

May 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to compare 2 different designs of nasal stents in conjunction with nasoalveolar molding appliance regarding the changes in nose and lip esthetics in infants with cleft lip and palate.

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

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kidney Shaped Nasal Stent	Active Comparator	Conventional NAM with kidney shaped nasal stent added to it.	Device: Grape Design Nasal Stent
Grape Design Nasal Stent	Experimental	Conventional NAM with grape shaped nasal stent added to it.	Device: Grape Design Nasal Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Grape Design Nasal Stent	Device	Grape Design Nasal Stent	Grape Design Nasal Stent Kidney Shaped Nasal Stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nase and lip esthetics	Measuring linear measurements on 2D photos.	Photos are planned to be taken before starting the treatment and right after finishing it.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Complete unilateral cleft lip and palate.
younger than 30 day old

Exclusion Criteria:

Syndromic patients.
older than 30 days old.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

30 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Abd-El-Ghafour, PhD	Contact	01007433288		m.abdelghafour@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry		Cairo		00202	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002971	Cleft Lip

Ancestor Terms

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided