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Not yet recruiting NCT07612423

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

No phase Interventional Alveolar Cleft Grafting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: grafting of the alveolar cleft, grafting of the alveolar cleft.
Who it may be relevant to
Registry conditions: Alveolar Cleft Grafting. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by CBCT analysis [Time frame: 6 months]
Secondary outcome measures (1)
  • Measurement of gained bone labio-palatal width and height in millimeter by CBCT analysis [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07612423 · 261226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗