Clinical trial 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Bone Grafting
Keywords: alveolar cleft
alveolar cleft bone graft
periosteum membrane
anterior ilium bone graft
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2025-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 9 -12 years, depending on dental age not chronological.
* systemically healthy patients (American Society of Anesthesiologists -ASA I and II)
* Patients secondary alveolar cleft patient.

Exclusion Criteria:

* Patients with recurrent palatal fistula.
* Existence of syndromic cleft palate.
* Patient with uncontrolled systematic disease.
* Patients undergoing radiotherapy or chemotherapy for malignancy.

Primary outcomes:
measure: Bone gain
timeFrame: 0-6 months
measure: Bone Density
timeFrame: Preoperative, 1week postoperative & sixth months.
Secondary outcomes:
measure: Pain at Donor site
timeFrame: Immediate postoperative. 6 months
measure: Pain at Recipient site
timeFrame: Immediate postoperative. 6 months
measure: Infection
timeFrame: Immediate postoperative
measure: Patient satisfaction
timeFrame: Immediate postoperative and 6months.
measure: Wound healing at donor and recipient site
timeFrame: Immediate postoperative. 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: School of Dentistry, Cairo.
state: Giza
Study officials:
affiliation: Cairo University
name: Tarek El faramawi, Lecturer of OMFS
role: STUDY_CHAIR
References:
citation: Abu-Shahba AG, Wilkman T, Kornilov R, Adam M, Salla KM, Linden J, Lappalainen AK, Bjorkstrand R, Seppanen-Kaijansinkko R, Mannerstrom B. Periosteal Flaps Enhance Prefabricated Engineered Bone Reparative Potential. J Dent Res. 2022 Feb;101(2):166-176. doi: 10.1177/00220345211037247. Epub 2021 Sep 11.