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

NCT05422196 | Completed

• 1 other identifier: A08080920
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Grafting

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control group

NO INTERVENTION

No platelet-rich fibrin was added to the cleft site during grafting.

Study group

EXPERIMENTAL

Platelet-rich fibrin was added to the cleft site during grafting.

Procedure: Platelet-rich fibrin

Interventions

Platelet-rich fibrin PROCEDURE

Addition of platelet-rich fibrin into the cleft site.

Study group

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Addakahlyia, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 16, 2022
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 2, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

EG (1)