Alveolar Cleft
Conditions
Keywords
alveolar cleft, iliac crest grafting, microplate, bone resorption, oronasal fistula
Brief summary
The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.
Detailed description
In conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. So alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula. In conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. In this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.
Interventions
PROCEDUREbilateral alveolar cleft grafting using iliac crest particulate and microplate fixation
bilateral alveolar cleft grafting using particulate iliac crest graft accompanied with fixation of graft and premaxilla using microplate
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old). * repaired cleft lip. * 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 unilateral maxillary alveolar cleft. * Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft * 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. * Active infection or severe inflammation in the area intended for graft placement * Unable to open mouth sufficiently to accommodate the surgical tooling. * Patients participating in other studies, if the present protocol could not be properly followed. * Unable to attend a 9-month follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone density immediate versus 6 months postoperatively. | 6 months | bone density changes are measured using CBCT after 6 months via HU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone width and height immediate versus 6 months postoperatively | 6 months | bone height and width changes are measured using CBCT after 6 months in mm |
Countries
Egypt
Contacts
Primary ContactMaha Ibrahim, bachelor of dentistry
Backup ContactAlaa Hassan, MSc
Outcome results
None listed