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

NCT06795919 | Not Yet Recruiting DMC

• 1 other identifier: Bone graft in alveolar cleft
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Alveolar Bone Grafting

Keywords

alveolar cleft; alveolar cleft bone graft; periosteum membrane; anterior ilium bone graft

Outcome Measures

Primary Outcomes (2)

• Bone gain

  CBCT , measured in cm

  0-6 months

• Bone Density

  CBCT , measured in Hounsfield units.

  Preoperative, 1week postoperative & sixth months.

Secondary Outcomes (5)

• Pain at Donor site

  Immediate postoperative. 6 months

• Pain at Recipient site

  Immediate postoperative. 6 months

• Infection

  Immediate postoperative

• Patient satisfaction

  Immediate postoperative and 6months.

• Wound healing at donor and recipient site

  Immediate postoperative. 6 months

Study Arms (1)

secondary surgical repair of alveolar cleft with cortico-cancellous anterior iliac bone graft.

EXPERIMENTAL

The cleft area is infiltrated with 1% xylocaine with epinephrine on the palatal and buccal side of the anterior maxilla. Two full thickness mucoperiosteal flaps are created by incising the anterior surface of the alveolar process, alongside the cleft ridge. The nasal mucosa is separated by an incision from the gingiva on both sides of maxilla. Flaps are lifted cautiously with a periosteal elevator along the labial surface of alveolar process to the piriform aperture. The nasal mucosa is reflected into the nose and the periosteum out of the cleft so that new bone can be grafted. The autogenic bone fills the cleft fissure, and it is covered with lifted flaps. The incision of mucous flap for covering clefts can be moved from the lateral sides of the alveolar process. It is advised to place the bone graft in the region of the piriform aperture to provide elevation and support for the base of ala nasi on the cleft. The skin incision line is made parallel to the iliac crest.

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

Interventions

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

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

secondary surgical repair of alveolar cleft with cortico-cancellous anterior iliac bone graft.

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nesma Mattar: lead
• Cairo University: collaborator

Study Sites (1)

School of Dentistry, Cairo.

Cairo, Giza Governorate, 12345, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34514892 BACKGROUND

Study Officials

• Tarek El faramawi, Lecturer of OMFS

  Cairo University

  STUDY CHAIR

Central Study Contacts

Nesma Mo Ibrahim, Lecturer Assistant of OMFS

CONTACT

nesmamattar@outlook.com; nesmamattar@outlook.com

Mostafa Ib Shindy, Professor of OMFS

CONTACT

00201121112222; m2shindy@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD candidate at Cairo University. Lecturer Assistant of Oral and Maxillofacial Surgery in New Giza University.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)