Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting (Alveolar cleft)

October 6 University

Status: Completed

Conditions: Alveolar Cleft; Alveolar Ridge Cleft

Treatments: Procedure: Alveolar ridge grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT06304376

OMFS/FSDC002

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 7 to 14 years old

Volunteers: No Healthy Volunteers

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.

7. Vulnerable patients.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

study group

Other group

Description:

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

Treatment:

Procedure: Alveolar ridge grafting