Evaluation of Shell Technique in Secondary Alveolar Cleft... | NCT06304376

Studies
Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting

NCT06304376

Sponsor

October 6 University

Status

Completed

Last Update Posted

Mar 12, 2024Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Alveolar Cleft
Alveolar Ridge Cleft

Interventions

Alveolar ridge grafting

Countries

Kuwait

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

Mar 2024

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

Mar 12, 2022Actual

Primary Completion Date

Nov 30, 2023Actual

Completion Date

Feb 22, 2024Actual

First Submitted Date

Mar 1, 2024

First Submission Date that Met QC Criteria

Mar 8, 2024

First Posted Date

Mar 12, 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

Mar 8, 2024

Last Update Posted Date

Mar 12, 2024Actual

Name	Class
Ministry of Health, Kuwait	OTHER_GOV

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Other	This study group contains of patient who had alveolar cleft, indicated for late secondary alveolar grafting	Procedure: Alveolar ridge grafting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alveolar ridge grafting	Procedure	Alveolar ridge grafting was carried out using anterior iliac crest bone graft. Khoury shell technique was the method of ridge reconstruction via a cortical bone shell was fixed away from alveolar ridge using two micro-screws and the gap created was filled by cancellous bone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Volumetric bone gain	bone volumetric gain and changes measured by CBCT analysis	4 months

Secondary Outcomes

Measure	Description	Time Frame
Eruption of the tooth in the cleft	Eruption of the tooth assessed clinically and radiographically	6-9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with alveolar ridge cleft
Males and females 7-14 years of age.
Patients with adequate oral hygiene.
Compliance with all requirements in the study and signing the informed consent.

Exclusion Criteria:

Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%).
Patients with systemic disease affecting bone healing.
Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications).
Patients with history of intravenous and/or oral bisphosphonate use.
Pathologic lesions or acute infection in the area of defect.
Patients with poor oral hygiene that are not amenable to motivation and improvement.

8. Vulnerable patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

14 Years

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
Ministry of Health, Farwaniya Hospital		Al Farwaniyah		81004	Kuwait

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