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

ConditionAlveolar Cleft Grafting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Immunocompromised patients.

patients with active periodontitis.

patients with inadequate oral hygiene.

Trial design

Design model

Parallel

Treatments tested in this trial

  • grafting of the alveolar cleft

    Procedure/Surgery

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

  • grafting of the alveolar cleft

    Procedure/Surgery

    grafting alveolar cleft with double iliac corticocancellous bone blocks technique with cancellous bone particles in between

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Intervention group / Study groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: