Alveolar Cleft
Conditions
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.
Interventions
PROCEDUREGrafting of the alveolar cleft
alveolar cleft grafting using either the conventional technique or the double cortex technique
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring graft height in millimeters | 9 months | CBCT scan analysis for measuring mean graft height in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft height in millimeters after 9 months of every graft for assessment of grafts height stability of both groups over 9 months. |
| Measuring graft width in millimeters | 9 months | CBCT scan analysis for measuring mean graft width in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft width in millimeters after 9 months of every graft for assessment of grafts width stability of both groups over 9 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measuring graft volume in cubic millimeter | 9 months | CBCT scan analysis for measuring graft volume in cubic millimeter of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring graft volume in cubic millimeter after 9 months of every graft for assessment of grafts volume stability of both groups over 9 months. |
Countries
Egypt
Contacts
Primary ContactLouai A Raafat, BDS
Outcome results
None listed