Clinical trial NCT06924216: Evaluation of Using Iliac Crest With and Without Platelet-Rich Fibrin in Repair of Congenital Alveolar Cleft
Official title: Clinical and Radiographic Evaluation of Using Iliac Crest Graft With and Without Platelet-Rich Fibrin (PRF) in Repair of Congenital Alveolar Cleft
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alveolar Clefts
Alveolar Bone Grafting
Alveolar Bone Loss
Keywords: alveolar clefts
iliac crest
graft
PRF
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in bucco-lingual thickness of the bone at the recipient site
timeFrame: 3 months and 6 months postoperatively
Secondary outcomes:
measure: Calculation of the volume of bone fill in the recipient site
timeFrame: 6 months postoperative
measure: wound dehiscence
timeFrame: immediate, 7 days and 14 days postoperative
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez Canal University
name: Mohamed S Hamed, professor
role: STUDY_DIRECTOR
affiliation: Suez Canal University
name: Osama Antar, professor
role: STUDY_DIRECTOR
affiliation: Suez Canal University
name: Mohamed A Elsholkamy, professor
role: STUDY_DIRECTOR
affiliation: Suez Canal University
name: Mohamed Nageh, Dr
role: STUDY_DIRECTOR
affiliation: Suez Canal University
name: Aliaa E Ebrahim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.