Sticky Bone Grafting With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft

Tanta University

Status: Completed

Conditions: Unilateral Alveolar Cleft of Maxilla

Treatments: Procedure: Unilateral alveolar cleft repair

Study type: Interventional

Funder types: Other

Identifiers

NCT07066293

#R-OS-11-22-2

Details and patient eligibility

About

The aim of this study is to evaluate using Sticky Bone grafting combined with concentrated growth factor membrane for repair of unilateral alveolar cleft.

Full description

This study will be carried out on ten patients with unilateral alveolar clefts, The patients will be recieved, clinically& radiographically examined and managed at Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.

Preoperative evaluation:

Clinical evaluation will include presence of oronasal fistulas, nasal regurgitation and Presence of erupting teeth in cleft. .Preoperative cone beam computed tomography (CBCT) scans will be analyzed to measure alveolar cleft dimensions and the total cleft defect volume will be calculated.

Surgical technique:

Under general anesthesia, mucoperiosteal flaps will be raised along the cleft margins, exposing the defect. The nasal lining will be sutured with 4/0 Vicryl, followed by the application of a concentrated growth factor (CGF) membrane to cover the nasal mucosa. The sticky bone graft will be packed tightly into the cleft, ensuring complete defect filling. A CGF membrane will be then placed over the graft to enhance stability and healing. The flaps will be sutured using tension-free interrupted 3/0 Vicryl sutures to ensure full coverage of the graft.

Postoperative evaluation:

The patients will be evaluated over a nine-months follow-up period clinically at intervals of 1st & 2nd weeks, then 1st ,3rd and 9th months for healing parameters such as infection, wound dehiscence, recurrence of oronasal fistulas, nasal regurgitation and graft exposure & radiographically by using CBCT for assessing graft volume, bone mineral density immediate, 3rd & 9th months postoperatively.

Enrollment: 10 patients

Sex: All

Ages: 13 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unilateral alveolar clefts requiring repair.
• patients free from any systemic disease that may affect normal healing of bone.
• patients at an age older than 12 years

Exclusion criteria

• Bilateral alveolar clefts.
• Immunocompromised patients.
• Syndromic patients.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft

Experimental group

Description:

This will include 10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane

Treatment:

Procedure: Unilateral alveolar cleft repair