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

Mansoura University12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alveolar Bone Grafting

Interventions

Platelet-rich fibrinPROCEDURE

Addition of platelet-rich fibrin into the cleft site.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Addakahlyia, Egypt

Outcomes

Primary Outcomes

Closure of oronasal fistula

* By questioning the patient if there's a nasal regurgitation or not. * Qualitative outcome (positive or negative).

Time frame: Ten days postoperatively

Closure of oronasal fistula

* By questioning the patient if there's a nasal regurgitation or not. * Qualitative outcome (positive or negative).

Time frame: 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)).

Time frame: 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)).

Time frame: Six months postoperatively

Data from ClinicalTrials.gov

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