Alveolar Cleft Reconstruction With Cortical-Shells

NCT06585566 | Recruiting

• 1 other identifier: 15
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Alveolar Cleft

Keywords

Bone graft; Cortical- shells; Radiographic Density; Horizontal bone gain; Vertical bone loss

Outcome Measures

Primary Outcomes (1)

• Horizontal bone width

  The amplitude of radiographic horizontal bone width change

  6 months consolidation period

Secondary Outcomes (2)

• Vertical bone level

  6 months consolidation period

• Bone density

  6 months consolidation period

Study Arms (1)

Secondary alveolar bone grafting (SBAG)

OTHER

A SABG technique that utilizes retromolar cortical shells and the underlying cancellous particulates to formulate a three-dimensional alveolar cleft reconstruction.

Procedure: Cortical-shell graft

Interventions

Cortical-shell graft PROCEDURE

Retromolar cortical shell graft technique for SABG

Secondary alveolar bone grafting (SBAG)

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Amr Gibaly

Cairo, 62764, Egypt

RECRUITING

Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.

Cairo, Egypt

RECRUITING

Central Study Contacts

Amr Hanafy Gibaly, PHD

CONTACT

01113336634; amrgibaly@dent.bsu.edu.eg

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: Associate Professor of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: October 4, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)