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

Not Applicable

Completed

• Conditions: Alveolar Bone Grafting
• Interventions: Procedure: Platelet-rich fibrin

• Registration Number: NCT05422196
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-12-01
• Status Verified: 2022-06
• Study Completion: 2022-06-02
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-13
• Last Update Submitted: 2022-06-13
• Study First Posted: 2022-06-16
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Platelet-rich fibrin	Platelet-rich fibrin was added to the cleft site during grafting.

Primary Outcome Measures

Name	Time	Method
Closure of oronasal fistula	Six months 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)).

Trial Locations

Locations (1)

Faculty of Dentistry, Mansoura University; 🇪🇬 Mansoura, Addakahlyia, Egypt