Alveolar Cleft Reconstruction With Cortical-Shells

January 19, 2025 updated by: Amr Gibaly, Beni-Suef University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 62764
      • Cairo, Egypt
        • Recruiting
        • Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Secondary alveolar bone grafting (SBAG)
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
Retromolar cortical shell graft technique for SABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal bone width
Time Frame: 6 months consolidation period
The amplitude of radiographic horizontal bone width change
6 months consolidation period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density
Time Frame: 6 months consolidation period
The radiographic bone density of the consolidated graft at the site of the reconstructed cleft
6 months consolidation period
Vertical bone level
Time Frame: 6 months consolidation period
The amplitude of radiographic vertical bone change
6 months consolidation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 4, 2024

First Posted (Actual)

September 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15 (Tishreen_University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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