Alveolar Cleft Grafting by Double Iliac Bone Blocks Versus Iliac Spongy Bone From Anterior Iliac Crest

Cairo University (CU)

Status: Unknown

Conditions: Alveolar Cleft

Treatments: Procedure: Grafting of the alveolar cleft

Study type: Interventional

Funder types: Other

Identifiers

NCT05283005

29-12-21

Details and patient eligibility

About

Reconstruction of Alveolar Cleft Using Double Iliac Corticocancellous Blocks in comparison with the gold standard technique ( cancellous bone ) both from anterior iliac crest.

Full description

This study will compare two techniques for the proper alveolar cleft reconstruction with adequate bone bridge formation of maximum bone quality, contour, and minimal resorption. One of them is packing autogenous particulate spongy bone from the anterior iliac crest (gold standard). While the other technique would be reconstruction of the cleft with two iliac corticocancellous bone blocks with cancellous bone in between. which benefits of the rapid revascularization and healing of cancellous bone and the strong mechanical properties of cortical bone that will aid in obtaining a proper reconstruction and form for the defect and can be applied to defects of any size.

Enrollment: 16 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with complete maxillary alveolar cleft either unilateral or bilateral at the age of mixed dentition (between 7 and 13 years old).

  • repaired cleft lip.
  • Patients with cleft lip and palate who have not undergone alveolar grafting procedure.
  • Patients with unerupted maxillary permanent canine in the cleft region.
  • Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
  • Both genders males and females will be included

Exclusion criteria

• General contraindications to surgical intervention of the area. Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft.

  • Patients with associated syndrome.
  • Patients requiring concomitant Orthognathic surgical procedure.
  • Subjected to irradiation in the head and neck area less than 1 year before surgery.
  • Untreated periodontitis.
  • Poor oral hygiene.
  • Uncontrolled diabetes.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.
  • Active infection or severe inflammation in the area intended for graft placement.
  • Patients participating in other studies, if the present protocol could not be properly followed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

alveolar cleft patients will be treated by conventional technique

Active Comparator group

Description:

Reconstruction of alveolar cleft by autogenous cancellous bone from the anterior iliac crest (gold standard technique).

Treatment:

Procedure: Grafting of the alveolar cleft

alveolar cleft patients will be treated by double cortex technique

Experimental group

Description:

Reconstruction of alveolar cleft by autogenous double iliac cortico-cancellous bone blocks from the anterior iliac crest.

Treatment:

Procedure: Grafting of the alveolar cleft