Alveolar Cleft Reconstruction With Cortical-Shells

Not Applicable

Recruiting

• Conditions: Alveolar Cleft
• Interventions: Procedure: Cortical-shell graft

• Registration Number: NCT06585566
• Lead Sponsor: Beni-Suef University

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 available

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-05
• Study Start: 2024-10-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-08-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Horizontal bone width	6 months consolidation period	The amplitude of radiographic horizontal bone width change

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Amr Gibaly; 🇪🇬 Cairo, Egypt

Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.; 🇪🇬 Cairo, Egypt