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NCT Number: NCT07612423

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

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.

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Key information

Conditions

Alveolar Cleft Grafting

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by CBCT analysis

    Time frame: 6 months

    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

Secondary outcomes

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

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 28, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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