NCT06795919

Use of Particulate Cortico- Cancellous Anterior Iliac Graft with Periosteum Membrane in Unilateral Alveolar Cleft Grafting Versus Particulate Cortico-cancellous Anterior Iliac Grafting Alone.

Use of Particulate Cortico- Cancellous Anterior Iliac Graft with Periosteal Membrane in Treatment of Unilateral Alveolar Cleft Grafting Versus Particulate Cortico-cancellous Anterior Iliac Grafting Alone a Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Nesma Mattar · Academic / Other
• Sex: All
• Age: 9 Years – 12 Years
• Healthy volunteers: Accepted

Summary

In the past few years, periosteal membrane has been used in orthopedic surgery as well as periodontal surgery as a mechanism to promote bone healing without the ingrowth of fibrous tissues. It has shown its efficiency in maintaining the bone volume and density in postoperative follow up. This can in turn solve the problem of potential bone loss in patients of alveolar cleft. The study aims to see if fixing the periosteum of the anterior ilium with tacks after bone graft application in the donor site will help maintain the graft and promote healing for the alveolar cleft patients

Detailed description

Cleft lip and palate are the most common congenital deformity affecting craniofacial structures. Delayed alveolar cleft defect presents a challenge for reconstruction to achieve functional and esthetic results. Many sources of bone graft have been shown in the literature: cortical or cancellous bone, iliac crest, cranial bone, mandibular symphysis, tibia, and rib. The main complication is graft loss partial or complete and/or fistula formation postoperative. Periosteal membrane was reported to be used in a comparative study in rabbits versus that of resorbable collagen membrane to assess iliac bone graft resorption. The results seem promising. Periosteum as a membrane shows superior reparative powers. In the past few years, periosteal membrane has been used in orthopedic surgery as well as periodontal surgery as a mechanism to promote bone healing without the ingrowth of fibrous tissues. It has shown its efficiency in maintaining the bone volume and density in postoperative follow up. This can in turn solve the problem of potential bone loss in patients of alveolar cleft. The study aims to see if fixing the periosteum of the anterior ilium with tacks after bone graft application in the donor site will help maintain the graft and promote healing for the alveolar cleft patients. The most common cause of poor lifestyle, speech and feeding for secondary alveolar cleft patient is the communication of the oral cavity with the nasal cavity. Radiation, teratogenic drugs, nutritional deficiency, chemical exposure, and maternal hypoxia are all predisposing factor to the incidence an infant developing cleft. The main aims in reconstruction surgery are to achieve complete anatomical and functional seal to obtain normal speech, without regurgitation of fluids or food into the nasal cavity. Another goal is to allow for normal maxillary growth. Fistula occurring has high incidence in appearing postoperative to the reconstruction surgery. This leads to future difficult management. Another possible complication is wound dehiscence and graft exposure. Several studies attempted to resolve the complications with different bone graft sources whether autogenous, xenograft or allograft. The literature shows the use of different membranes to preserve the graft such as: PRF, collagen membrane and pericardium or completely without. The main objective for conducting this research is to check if the usage of periosteum of the same donor site of the anterior ilium will in fact preserve the bone graft volume and density of the known gold standard graft and prevent possible complications. The Periosteal flap stretch with fixation using tacks overlying the bone graft in cleft patients. It will be compared to using the gold standard corticocancellous graft without use of periosteal membrane. Periosteum is a specialized connective tissue forming a thin and fibrous membrane firmly anchored to bone. In children, it is thicker, more vascular, and more loosely attached. It has high bone forming potential. Many studies show that periosteum regenerates both bone and cartilage. The periosteum consists of two layers; the outer layer containing fibroblasts, vessels and sharpey's fibers. The inner layer contains undifferentiated mesenchymal cells, capillaries, and osteoblasts. This induces hematoma followed by callus formation during healing as it triggers sequences of cellular and biochemical events.

Conditions

• Alveolar Bone Grafting

Interventions

Type	Name	Description
PROCEDURE	: delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon	skin incision was marked 2-4 cm from the crest to anterior iliac spine height. This is done to avoid pain at the beltline if the incision is made directly over the anterior ilium. As well as avoid injury to the lateral femoral cutaneous nerve. After the anatomical marking are drawn using betadine solution, the site is injected with local anesthesia at the subcutaneous level. The skin incision line is made parallel to the iliac crest and posterior to the anterior iliac spine. Scalpel blade number 10 is used. The incision of the skin and subcutaneous fat was performed. Blunt dissection is carried out at the level of subcutaneous tissues to separate the fascia from fat. Cautery is used to control any hemorrhage. Using a number 15 blade, fascia was incised which covers the iliac spine. A hypo vascular plane was identified. It is located over the anterior iliac spine, as well as between the insertions of tensor fascia laterally and the external and the transverse abdominal muscles medially

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

1 site across 1 country: Egypt