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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Alveolar Bone Loss; Alveolar Bone Grafting; Alveolar Clefts
• Intervention / Treatment: Procedure: alveolar bone grafting Plus Platelet rich fibrin; Procedure: alveolar bone grafting

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).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 41522
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with congenital alveolar cleft who need secondary alveolar cleft repair.
2. Patients who are medically fit for surgery under general anaesthesia

Exclusion Criteria:

1. ASA 4 OR ASA 5 patients
2. Uncooperative patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with platelet-rich fibrin; study group: the patients will be treated with iliac crest bone graft with platelet-rich fibrin	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; Other Names: PRF
Active Comparator: without Platelet-rich fibrin; control group : the patients will be treated with iliac crest bone graft only	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; Other Names: Repair of alveolar clefts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in bucco-lingual thickness of the bone at the recipient site	Post-operative cone beam computed tomographic radiographs will be done using the Scanora 3DX imaging system using a CMOS flat panel detector with isotropic voxel size 133 µm. The x-ray tube that is used to scan the patients possesses a current intensity of 10 mA, 90 KVp, and a focal spot size of 0.5 mm. The scanning time is 14 seconds of pulsed exposure, resulting in an effective exposure time of 3.2 seconds to scan FOV (field of view) of 14 cm height × 16.5 cm width. The raw DICOM data set images will be imported to the On-Demand software (Cybermed, Seoul, Korea) for secondary reconstruction and image analysis. CBCT will be performed, and linear measurements will be obtained in axial, sagittal, and coronal cuts to assess the changes in buccolingual thickness of the bone at the recipient site 3 months and 6 months post-operatively.	3 months and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculation of the volume of bone fill in the recipient site	The volume of remaining alveolar defect around the bone graft at 6 months will be measured and subtracted from the actual alveolar defect volume to calculate the volume of bone fill. The actual volume of alveolar bone graft will be represented as a percentage of bone fill of the alveolar defect volume (Preoperative alveolar Defect Volume minus Postoperative residual defect volume / Preoperative Alveolar defect volume X 100)	6 months postoperative
wound dehiscence	Clinical evaluation for wound dehiscence immediate, 7 days, and 14 days postoperatively to detect any complications such as infection, flap dehiscence, or fistula formation. Then the percentage of cases with soft tissue complications will be calculated	immediate, 7 days and 14 days postoperative

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Director: Mohamed A Elsholkamy, professor, Suez Canal University; Study Director: Mohamed S Hamed, professor, Suez Canal University; Study Director: Osama Antar, professor, Suez Canal University; Study Director: Mohamed Nageh, Dr, Suez Canal University; Principal Investigator: Aliaa E Ebrahim, Suez Canal University

Publications and helpful links

General Publications

• Bayerlein T, Proff P, Heinrich A, Kaduk W, Hosten N, Gedrange T. Evaluation of bone availability in the cleft area following secondary osteoplasty. J Craniomaxillofac Surg. 2006 Sep;34 Suppl 2:57-61. doi: 10.1016/S1010-5182(06)60013-9.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: PRF; graft; iliac crest; alveolar clefts
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: 2024/801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No