Status:

COMPLETED

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

Lead Sponsor:

Mansoura University

Conditions:

Alveolar Bone Grafting

Eligibility:

All Genders

9-14 years

Phase:

NA

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 f...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 2 2022

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT05422196

Start Date

October 1 2020

End Date

June 2 2022

Last Update

June 16 2022

Active Locations (1)

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Faculty of Dentistry, Mansoura University

Al Mansurah, Addakahlyia, Egypt, 35516