Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting

October 6 University14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alveolar Cleft Alveolar Ridge Cleft

Interventions

Alveolar ridge graftingPROCEDURE

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

Eligibility

Sex: ALLMin age: 7 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with alveolar ridge cleft 2. Males and females 7-14 years of age. 3. Patients with adequate oral hygiene. 4. Compliance with all requirements in the study and signing the informed consent. Exclusion Criteria: 1. Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%). 2. Patients with systemic disease affecting bone healing. 3. Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications). 4. Patients with history of intravenous and/or oral bisphosphonate use. 5. Pathologic lesions or acute infection in the area of defect. 6. Patients with poor oral hygiene that are not amenable to motivation and improvement. 8\. Vulnerable patients.

Locations (1)

Ministry of Health, Farwaniya Hospital

Al Farwānīyah, Kuwait

Outcomes

Primary Outcomes

Volumetric bone gain

bone volumetric gain and changes measured by CBCT analysis

Time frame: 4 months

Secondary Outcomes

Eruption of the tooth in the cleft

Eruption of the tooth assessed clinically and radiographically

Time frame: 6-9 months

Data from ClinicalTrials.gov

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