Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin

Conditions
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Alveolar Bone Grafting

Intervention / Treatment
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* Procedure: Platelet-rich fibrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I. Patients seeking treatment and accepting to be enrolled in the study, so as their guardians. Patients who will age 9-14 years old by the surgery day. 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: Patients with systemic illness, i.e. ASA(22) classes II, III, IV, and V. Patients with previously operated alveolar clefts and seeking revision for the same cleft. Patients that wouldn't be able to attend the recalls. Patients with other craniofacial anomalies and associated syndrome conditions. Edentulous maxilla, atypical or non-described cleft diagnosis. Patients with history of chemotherapy or radiotherapy.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No platelet-rich fibrin was added to the cleft site during grafting. | |
| Experimental: Study group<br>Platelet-rich fibrin was added to the cleft site during grafting. | Procedure: Platelet-rich fibrin<br>* Addition of platelet-rich fibrin into the cleft site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of oronasal fistula | By questioning the patient if there's a nasal regurgitation or not. Qualitative outcome (positive or negative). | Ten days postoperatively | 
| Closure of oronasal fistula | By questioning the patient if there's a nasal regurgitation or not. Qualitative outcome (positive or negative). | Six months postoperatively | 
| Volume of newly formed bone | By computerized measurement on the Cone-Beam Computed Tomography software. (Volume tool in Invesalius ® software (Invesalius, CTI, Brazil)). Quantitative outcome (in cubic millimetres (mm3)). | Six months postoperatively | 
| Average density of newly formed bone | 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)). | Six months postoperatively |