Actively Recruiting

Phase Not Applicable
Age: 8Years - 15Years
All Genders
ID06585566

Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells A Case Series Study

Led by Beni-Suef University · Updated on 2025-01-22

7

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a surgical technique called secondary alveolar bone grafting (SABG) for children aged 8 to 15 years with unilateral maxillary alveolar clefts. The goal is to stabilize the upper jaw by reconstructing the alveolar cleft to promote proper growth, tooth eruption, and orthodontic movement. This study assesses the outcomes of a specific SABG approach using retromolar cortical shells for reconstruction. The procedure involves using retromolar cortical shells along with cancellous bone particles to create a three-dimensional reconstruction of the alveolar cleft. This technique is designed to rebuild the bone structure in the affected area. Participants will receive this surgical graft as the main intervention. During the study, researchers will monitor bone healing and stability over a six-month consolidation period. They will evaluate horizontal bone width, vertical bone level, and bone density to measure the success of the graft. Participants will be followed throughout this period to assess the reconstruction outcomes and overall bone health.

CONDITIONS

Brief Title

Alveolar Cleft Reconstruction With Cortical-Shells

Who Can Participate

Age: 8Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 8 to 15 years
  • Both sexes included
  • Unilateral maxillary alveolar cleft
  • Good oral hygiene and general good health
Not Eligible

You will not qualify if you...

  • Clinical or radiographic signs of local maxillary disease or palatal fistulae
  • Bilateral alveolar clefts
  • Cleft-associated syndromes
  • Systemic diseases affecting bone harvest or graft healing
  • History of previous failed alveolar cleft reconstruction
  • Poor oral hygiene or general health issues that may affect participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - 6 months consolidation period

Participants undergo alveolar cleft reconstruction using the retromolar cortical shell graft technique followed by immediate post-operative care.

Trial Site Locations

Total: 2 locations

1

Amr Gibaly

Cairo, Egypt, 62764

Actively Recruiting

2

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

Cairo, Egypt

Actively Recruiting

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Research Team

A

Amr Hanafy Gibaly, PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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