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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorNesma Mattar

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon

    Procedure/Surgery

    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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: secondary surgical repair of alveolar cleft with cortico-cancellous anterior iliac bone graft.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bone gain

CBCT , measured in cm

Time frame
0-6 months
2

Bone Density

CBCT , measured in Hounsfield units.

Time frame
Preoperative, 1week postoperative & sixth months.

Secondary outcomes

1

Pain at Donor site

Visual Analogue scale from 0 to 10.

Time frame
Immediate postoperative. 6 months
2

Pain at Recipient site

Visual Analogue scale from 0 to 10.

Time frame
Immediate postoperative. 6 months
3

Infection

Yes/no

Time frame
Immediate postoperative
4

Patient satisfaction

Yes/NO

Time frame
Immediate postoperative and 6months.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

School of Dentistry, Cairo. Status unavailable 12345, Cairo, Giza GovernorateEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nesma Mattar

Lead sponsor

Cairo University

Sponsor institution

Cairo University

Collaborator

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