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

NCT06924216 | Active Not Recruiting DMC

• 1 other identifier: 2024/801
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Alveolar Clefts; Alveolar Bone Grafting; Alveolar Bone Loss

Keywords

alveolar clefts; iliac crest; graft; PRF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Calculation of the volume of bone fill in the recipient site

  6 months postoperative

• wound dehiscence

  immediate, 7 days and 14 days postoperative

Study Arms (2)

with platelet-rich fibrin

EXPERIMENTAL

study group: the patients will be treated with iliac crest bone graft with platelet-rich fibrin

Procedure: alveolar bone grafting Plus Platelet rich fibrin

without Platelet-rich fibrin

ACTIVE COMPARATOR

control group : the patients will be treated with iliac crest bone graft only

Procedure: alveolar bone grafting

Interventions

alveolar bone grafting PROCEDURE

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

Also known as: Repair of alveolar clefts

without Platelet-rich fibrin

alveolar bone grafting Plus Platelet rich fibrin PROCEDURE

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

Also known as: PRF

with platelet-rich fibrin

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ASA 4 OR ASA 5 patients
• Uncooperative patients

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 41522, Egypt

Location

Related Publications (1)

• 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.

  PMID: 17071393 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Alveolar Bone Grafting

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Surgical Procedures, Operative; Osteotomy; Orthopedic Procedures; Dentistry

Study Officials

• Mohamed S Hamed, professor

  Suez Canal University

  STUDY DIRECTOR

• Osama Antar, professor

  Suez Canal University

  STUDY DIRECTOR

• Mohamed A Elsholkamy, professor

  Suez Canal University

  STUDY DIRECTOR

• Mohamed Nageh, Dr

  Suez Canal University

  STUDY DIRECTOR

• Aliaa E Ebrahim

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 11, 2025
• Study Start: April 27, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)