Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique

Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique A Randomized Clinical Trial

The current study aims to compare the double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between versus the double iliac corticocancellous bone blocks technique with iliac cancellous bone particles in between in the tertiary cleft grafting to find out which technique maintained better graft width, height, and volume with the least adverse effects after the healing period and hence would allow for restoration of the targeted function and esthetics and improve the cleft patients psychologically and hence improve their quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Cleft Grafting
• Intervention / Treatment: Procedure: grafting of the alveolar cleft; Procedure: grafting of the alveolar cleft

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with unilateral alveolar cleft who missed the mixed dentition phase window.
• patients with previously repaired cleft lip and palate.
• patients with proper oral hygiene.

Exclusion Criteria:

• Immunocompromised patients.
• patients with active periodontitis.
• patients with inadequate oral hygiene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group / Study group; Patients with unilateral alveolar cleft beyond mixed dentition treated with the double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between	Procedure: grafting of the alveolar cleft; patients with unilateral alveolar cleft treated withthe double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between.; Procedure: grafting of the alveolar cleft; grafting alveolar cleft with double iliac corticocancellous bone blocks technique with cancellous bone particles in between
Active Comparator: Control group; Patients with unilateral alveolar cleft beyond mixed dentition treated with the double iliac corticocancellous bone blocks technique with iliac cancellous bone particles in between.	Procedure: grafting of the alveolar cleft; patients with unilateral alveolar cleft treated withthe double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between.; Procedure: grafting of the alveolar cleft; grafting alveolar cleft with double iliac corticocancellous bone blocks technique with cancellous bone particles in between

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by CBCT analysis	Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by comparison between CBCT scans that will be taken postoperatively, and after 6 months postoperatively. volume assessment will be by specialized software 3D Slicer	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of gained bone labio-palatal width and height in millimeter by CBCT analysis	Measurement of gained bone labio-palatal width and height in millimeter after 6 months of graft healing by comparison between CBCT scans that will be taken postoperatively, and after 6 months postoperatively by specialized software Atomica ai.	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 23, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 261226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No