Clinical trial NCT05283005: Alveolar Cleft Grafting by Double Iliac Bone Blocks Versus Iliac Spongy Bone From Anterior Iliac Crest
Official title: Alveolar Cleft Reconstruction Using Double Iliac Corticocancellous Bone Blocks Technique Versus Particulate Autogenous Spongy Bone Graft From Anterior Iliac Crest. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Cleft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measuring graft height in millimeters
timeFrame: 9 months
measure: Measuring graft width in millimeters
timeFrame: 9 months
Secondary outcomes:
measure: Measuring graft volume in cubic millimeter
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo university
Study officials:
References: