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

NCT07612423 | Not Yet Recruiting

• 1 other identifier: 261226
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alveolar Cleft Grafting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of gained bone labio-palatal width and height in millimeter by CBCT analysis

  6 months

Study Arms (2)

Intervention group / Study group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

grafting of the alveolar cleft PROCEDURE

patients with unilateral alveolar cleft treated withthe double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between.

Intervention group / Study group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

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: Associate Professor

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-05