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

M

Mansoura University

Status

Completed

Conditions

Alveolar Bone Grafting

Treatments

Procedure: Platelet-rich fibrin

Study type

Interventional

Funder types

Other

Identifiers

NCT05422196
A08080920

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

9 to 14 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Control group
No Intervention group
Description:
No platelet-rich fibrin was added to the cleft site during grafting.
Study group
Experimental group
Description:
Platelet-rich fibrin was added to the cleft site during grafting.
Treatment:
Procedure: Platelet-rich fibrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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