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

Alveolar Bone Grafting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422196
• Other study ID #: A08080920
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 2, 2022

Study information

• Verified date: June 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Grafting

Intervention

Procedure:
• Platelet-rich fibrin
Addition of platelet-rich fibrin into the cleft site.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Mansoura University	Mansoura	Addakahlyia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of oronasal fistula	By questioning the patient if there's a nasal regurgitation or not.; Qualitative outcome (positive or negative).	Ten days postoperatively
Primary	Closure of oronasal fistula	By questioning the patient if there's a nasal regurgitation or not.; Qualitative outcome (positive or negative).	Six months postoperatively
Primary	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
Primary	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