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

NCT07442279 | Not Yet Recruiting

• 1 other identifier: OMFS 3 3 8
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alveolar Cleft

Keywords

bilateral alveolar cleft, corticocancellous bone blocks; particulate bone; grafting; iliac crest

Outcome Measures

Primary Outcomes (1)

• bone volume

  Measurement of alveolar bone volume using radiographic imaging (CBCT) to compare bone maintenance between the two techniques

  6 months

Study Arms (2)

Double Iliac Corticocancellous Bone Block Graft

EXPERIMENTAL

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

Conventional Autogenous Particulate Bone Graft

ACTIVE COMPARATOR

Participants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest.

Procedure: Autogenous Particulate Bone Graft

Interventions

Iliac Corticocancellous Bone Block Graft PROCEDURE

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

Double Iliac Corticocancellous Bone Block Graft

Autogenous Particulate Bone Graft PROCEDURE

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.

Conventional Autogenous Particulate Bone Graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Government, 12613, Egypt

Location

Study Officials

• Mahmoud Samy Abdelmoniem, PhD researcher

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Samy Abdelmoniem, PhD Researcher

CONTACT

0020201002752193; mhsamy.ms@gmail.com

mohamed omara, associate professor

CONTACT

0020201144452862; mohammed.omara@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher, Cairo university

Model Details: Participants will be randomly assigned into two parallel groups. The first group will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts, while the second group will receive conventional autogenous particulate bone grafting. Clinical and radiographic outcomes will be compared between both groups

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)