Alveolar Bone Grafting
Conditions
Brief summary
This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. This grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested.
Interventions
PROCEDUREPlatelet-rich fibrin
Addition of platelet-rich fibrin into the cleft site.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I. 2. Patients seeking treatment and accepting to be enrolled in the study, so as their guardians. 3. Patients who will age 9-14 years old by the surgery day. 4. Patients with adequate chin bone volume that could be harvested without marked donor site morbidity, as pre-determined by cone beam computed tomography.
Exclusion criteria
1. Patients with systemic illness, i.e. ASA(22) classes II, III, IV, and V. 2. Patients with previously operated alveolar clefts and seeking revision for the same cleft. 3. Patients that wouldn't be able to attend the recalls. 4. Patients with other craniofacial anomalies and associated syndrome conditions. 5. Edentulous maxilla, atypical or non-described cleft diagnosis. 6. Patients with history of chemotherapy or radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Closure of oronasal fistula | Ten days postoperatively | * By questioning the patient if there's a nasal regurgitation or not. * Qualitative outcome (positive or negative). |
| Volume of newly formed bone | Six months postoperatively | * By computerized measurement on the Cone-Beam Computed Tomography software. (Volume tool in Invesalius ® software (Invesalius, CTI, Brazil)). * Quantitative outcome (in cubic millimetres (mm3)). |
| Average density of newly formed bone | Six months postoperatively | * By computerized measurement on the Cone-Beam Computed Tomography software. (Average density tool in Invesalius ® software (Invesalius, CTI, Brazil)). * Quantitative outcome (in Hounsfield Units (HU)). |
Countries
Egypt
Outcome results
None listed