About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Patients with recurrent palatal fistula.
Existence of syndromic cleft palate.
Patient with uncontrolled systematic disease.
Patients undergoing radiotherapy or chemotherapy for malignancy.
Trial design
Single group
Treatments tested in this trial
: delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon
Procedure/Surgeryskin 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
Treatment groups
Trial outcomes
Primary outcomes
Bone gain
CBCT , measured in cm
Bone Density
CBCT , measured in Hounsfield units.
Secondary outcomes
Pain at Donor site
Visual Analogue scale from 0 to 10.
Pain at Recipient site
Visual Analogue scale from 0 to 10.
Infection
Yes/no
Patient satisfaction
Yes/NO
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
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