Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting

NCT06304376 | Completed

• 1 other identifier: OMFS/FSDC002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Cleft; Alveolar Ridge Cleft

Keywords

alveolar ridge cleft; Khoury shell technique; 3D alveolar ridge reconstruction; anterior iliac crest bone graft

Outcome Measures

Primary Outcomes (1)

• Volumetric bone gain

  bone volumetric gain and changes measured by CBCT analysis

  4 months

Secondary Outcomes (1)

• Eruption of the tooth in the cleft

  6-9 months

Study Arms (1)

study group

OTHER

This study group contains of patient who had alveolar cleft, indicated for late secondary alveolar grafting

Procedure: Alveolar ridge grafting

Interventions

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

study group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Vulnerable patients.

Sponsors & Collaborators

• October 6 University: lead
• Ministry of Health, Kuwait: collaborator

Study Sites (1)

Ministry of Health, Farwaniya Hospital

Al Farwānīyah, 81004, Kuwait

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priniciple investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 12, 2024
• Study Start: March 12, 2022
• Primary Completion: November 30, 2023
• Study Completion: February 22, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)