Bilateral Alveolar Cleft Reconstruction Using Double Iliac Bone Blocks vs Particulate Grafting

February 27, 2026 updated by: Mahmoud Samy, Cairo University

A Randomized Controlled Clinical Trial Comparing Double Iliac Corticocancellous Bone Blocks Versus Conventional Autogenous Particulate Bone Grafting for Bilateral Alveolar Cleft Reconstruction

This study aims to compare the clinical outcomes of bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts versus conventional autogenous particulate bone grafting. The study will evaluate graft stability, bone volume, and postoperative complications in patients with bilateral alveolar clefts. Participants will be allocated into two groups, each receiving one of the two grafting techniques. Clinical and radiographic assessments will be performed during follow-up to determine the effectiveness and predictability of each method

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Alveolar cleft reconstruction is a critical component in the comprehensive management of patients with cleft lip and palate, aiming to restore alveolar continuity, facilitate tooth eruption, and provide support for the nasal base. Autogenous bone grafting remains the gold standard for alveolar cleft repair, with the iliac crest being the most commonly used donor site due to its rich cancellous bone content.

Conventional particulate cancellous bone grafting has been widely used with predictable outcomes; however, it may be associated with graft resorption and reduced structural stability, particularly in bilateral alveolar cleft cases. Recently, the use of corticocancellous bone block grafts has been proposed to enhance graft stability, maintain volume, and improve overall outcomes.

This study aims to compare double iliac corticocancellous bone block grafts with conventional autogenous particulate bone grafting in the reconstruction of bilateral alveolar clefts. Patients diagnosed with bilateral alveolar clefts and meeting the inclusion criteria will be enrolled and allocated into two groups. One group will receive double iliac corticocancellous bone block grafts, while the other will undergo reconstruction using conventional particulate bone grafting techniques.

Clinical and radiographic evaluations will be performed to assess graft stability, bone volume, and postoperative complications. Follow-up assessments will be conducted at predefined intervals to evaluate the success and predictability of each technique. The findings of this study are expected to provide evidence regarding the most effective grafting approach for bilateral alveolar cleft reconstruction

Study Type

Interventional

Enrollment (Estimated)

20

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

  • Name: Mahmoud Samy Abdelmoniem, phd researcher
  • Phone Number: 0020201002752193
  • Email: mhsamy.ms@gmail.com

Study Contact Backup

Study Locations

  • Egypt
    • Cairo Government
      • Cairo, Cairo Government, Egypt, 12613
        • Faculty of Dentistry, Cairo University
        • Contact:
          • Mahmoud Samy Abdelmoniem, phd researcher
          • Phone Number: 0020201002752193
          • Email: mhsamy.ms@gmail.com
        • Contact:
        • Principal Investigator:
          • Mahmoud Abdelmoniem, PhD researcher

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients diagnosed with bilateral alveolar cleft requiring secondary alveolar bone graft.
  • Medically fit for surgery under general anesthesia.
  • Adequate soft tissue coverage at the cleft site.
  • Patients (or guardians) able to provide informed consent.

Exclusion Criteria:

  • Unilateral alveolar cleft.
  • Presence of systemic diseases affecting bone healing (e.g., Diabetes Mellitus uncontrolled, osteoporosis).
  • Syndromic cleft patients.
  • Poor oral hygiene or active infection at the surgical site.
  • History of radiotherapy in the maxillofacial region.
  • Contraindications to general anesthesia.
  • Patients unwilling or unable to comply with follow-up.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double Iliac Corticocancellous Bone Block Graft
Participants will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts harvested from the iliac crest
Procedure: Iliac Corticocancellous Bone Block Graft
participants will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone blocks harvested from the iliac crest. The grafts will be secured to premaxilla by micro screws to restore alveolar continuity, facilitate tooth eruption, and improve bone volume
Active Comparator: Conventional Autogenous Particulate Bone Graft
Participants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest.
Procedure: Autogenous Particulate Bone Graft
participants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest. The graft material will be packed into the alveolar defect to restore bone continuity and support future tooth eruption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone volume
Time Frame: 6 months
Measurement of alveolar bone volume using radiographic imaging (CBCT) to compare bone maintenance between the two techniques
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mahmoud Samy Abdelmoniem, PhD researcher, Cairo 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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMFS 3 3 8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The study data will be used only for research purposes and will not be made publicly available

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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