NCT06924216

Evaluation of Using Iliac Crest With and Without Platelet-Rich Fibrin in Repair of Congenital Alveolar Cleft

Clinical and Radiographic Evaluation of Using Iliac Crest Graft With and Without Platelet-Rich Fibrin (PRF) in Repair of Congenital Alveolar Cleft

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

A randomized clinical trial aims to evaluate the clinical and radiographic outcomes of the repair of congenital alveolar clefts using Iliac crest graft with and without mixing with platelet-rich fibrin

Detailed description

Alveolar clefts occur in response to deviations from normal development in the growth, exposure, and fusion of the frontal eminence. The most common alveolar portion of the cleft is located between the central incisors and canines. The treatment of alveolar clefts is multidisciplinary and aimed at restoring normal ridge contour and functionality. Surgical wound closure is insufficient to repair bony defects, Additional materials are needed for these types of defects, such as bone grafts. Aim: The aim of this study is to evaluate the efficiency of using iliac crest bone graft with and without platelet-rich fibrin in repair of alveolar clefts. Methodology: This study will be conducted on 16 patients with alveolar clefts. The patients will be divided equally and randomly into 2 groups: Group 1 : 8 patients will be treated with iliac crest bone graft only (control group).Group 2: 8 patients will be treated with iliac crest bone graft with platelet-rich fibrin (study group).

Conditions

• Alveolar Clefts
• Alveolar Bone Grafting
• Alveolar Bone Loss

Interventions

Type	Name	Description
PROCEDURE	alveolar bone grafting	cancellous iliac crest bone will be harvested following the usual surgical procedure. For patients of group a-PRF, it was mixed with 1 cc of the supernatant previously collected, in order to obtain a cohesive bone graft, easier to manipulate. The oral mucosal lining will be closed, and a membrane of PRF (PRF group) will be put over the suture line. The alveolar cleft will be then filled with cancellous iliac crest bone along its entire height. A new membrane of PRF will be placed over the bone graft, in order to enclose and protect it. Finally, muco-periosteal flaps will be advanced and sutured without tension over the alveolar crest
PROCEDURE	alveolar bone grafting Plus Platelet rich fibrin	the PRF group: centrifugation at 1300 rpm during 5 minutes, collection of 1 cc of the supernatant, and centrifugation at 1300 rpm during 3 minutes. Careful removal of the clot and separation from the red blood cell fraction with scissors. the Platelet-rich fibrin will be added to the surgical site mixed with the iliac crest bone graft and it will also be used as a membrane before closure of the mucoperiosteal flap

Timeline

• Start date: 2024-04-27
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2025-04-11
• Last updated: 2025-04-11

Locations

1 site across 1 country: Egypt