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

Suez Canal University

Status: Active, not recruiting

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

Treatments: Procedure: alveolar bone grafting Plus Platelet rich fibrin; Procedure: alveolar bone grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT06924216

2024/801

Details and patient eligibility

About

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

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

16 participants in 2 patient groups

with platelet-rich fibrin

Experimental group

Description:

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

Treatment:

Procedure: alveolar bone grafting Plus Platelet rich fibrin

without Platelet-rich fibrin

Active Comparator group

Description:

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

Treatment:

Procedure: alveolar bone grafting