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

Not Applicable

Active, not recruiting

• Conditions: Alveolar Clefts; Alveolar Bone Grafting; Alveolar Bone Loss

• Registration Number: NCT06924216
• Lead Sponsor: Suez Canal University

Brief 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).

Study Timeline

• Study Start: 2024-04-27
• Study First Submitted: 2025-03-12
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in bucco-lingual thickness of the bone at the recipient site	3 months and 6 months postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Calculation of the volume of bone fill in the recipient site	6 months postoperative	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)
wound dehiscence	immediate, 7 days and 14 days postoperative	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

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismailia, Egypt