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临床试验/NCT06795919
NCT06795919尚未招募不适用

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

Nesma Mattar1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Bone gain

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon (Procedure)

结局指标

主要结局

Bone gain

时间窗: 0-6 months

CBCT , measured in cm

Bone Density

时间窗: Preoperative, 1week postoperative & sixth months.

CBCT , measured in Hounsfield units.

次要结局

  • Pain at Donor site(Immediate postoperative. 6 months)
  • Patient satisfaction(Immediate postoperative and 6months.)
  • Wound healing at donor and recipient site(Immediate postoperative. 6 months)
  • Pain at Recipient site(Immediate postoperative. 6 months)
  • Infection(Immediate postoperative)

研究者

发起方
Nesma Mattar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nesma Mattar

PHD candidate at Cairo University. Lecturer Assistant of Oral and Maxillofacial Surgery in New Giza University.

Cairo University

研究点 (1)

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