Alveolar Cleft Reconstruction With Cortical-Shells | NCT06585566

Studies
Alveolar Cleft Reconstruction With Cortical-Shells

NCT06585566

Sponsor

Beni-Suef University

Status

Recruiting

Last Update Posted

Jan 22, 2025Actual

Enrollment

7Estimated

Phase

Not Applicable

Conditions

Alveolar Cleft

Interventions

Cortical-shell graft

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

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2024Actual

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Sep 3, 2024

First Submission Date that Met QC Criteria

Sep 4, 2024

First Posted Date

Sep 5, 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

Jan 19, 2025

Last Update Posted Date

Jan 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amr Gibaly, Associate Professor of Oral and Maxillofacial Surgery, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef UniversityOTHER

Collaborators

Not provided

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

The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.

The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.

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

7Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Secondary alveolar bone grafting (SBAG)	Other	A SABG technique that utilizes retromolar cortical shells and the underlying cancellous particulates to formulate a three-dimensional alveolar cleft reconstruction.	Procedure: Cortical-shell graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cortical-shell graft	Procedure	Retromolar cortical shell graft technique for SABG	Secondary alveolar bone grafting (SBAG)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Horizontal bone width	The amplitude of radiographic horizontal bone width change	6 months consolidation period

Secondary Outcomes

Measure	Description	Time Frame
Vertical bone level	The amplitude of radiographic vertical bone change	6 months consolidation period
Bone density	The radiographic bone density of the consolidated graft at the site of the reconstructed cleft

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
good oral hygiene and general good health

Exclusion Criteria:

The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
A history of previous failed alveolar cleft reconstruction.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amr Hanafy Gibaly, PHD	Contact	01113336634		amrgibaly@dent.bsu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amr Gibaly	Recruiting	Cairo		62764	Egypt

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