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临床试验/NCT04433117
NCT04433117已完成2 期

Bone Quality and Quantity in the Maxillary Sinus Grafted With Xenograft or Synthetic Bone Substitute: A Radiographic and Histomorphometric Randomized Controlled Clinical Study

Mohanad Al-Sabbagh2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年6月17日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements

研究概览

简要总结

Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction when socket preservation is not applied. In addition, extraction of posterior maxillary teeth causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the teeth. These anatomic sinus limitations and alveolar bone deficiencies are the main challenges for dental implant placement. Different bone substitutes have been used to augment bone in pneumatized maxillary sinuses.

Scaffolding materials such as xenografts or synthetics substitutes have been proven to be a viable alternative.

Xenografts are obtained from nonhuman species and serve as a scaffold for the formation of new bone (osteoconduction). Histologic evaluation of maxillary sinuses grafted with xenografts revealed newly formed bone to be mostly woven bone with some remodeling to lamellar bone. These histologic findings reaffirm the osteoconductive ability of xenografts when used as the sole grafting material in maxillary sinus augmentation. Xenografts appear to be an effective method for maxillary sinus grafting and demonstrate limited resorption over time. Sinuses augmented with synthetic bone substitute (SBS) also appear to successfully integrate based on recent histomorphometric studies. Vascularization and trabecular bone formation in sinuses grafted with SBS has been previously demonstrated. One type of SBS includes porous granules of bioactive and resorbable silica-calcium phosphate nanocomposite (ShefaBone). ShefaBone grafts offer a novel alternative that can potentially unite the 3 salient bone-forming properties (osteoinduction, osteoconduction, and osteogenesis). ShefaBone has unique properties including: 1) bioactivity 2) bioresorbablility, and 3) allowing for the uptake of calcium ions from the physiological solution and releasing phosphate and silicate ions which aid in bone formation. A material with such properties will substitute bone in a more controlled and effective combination that can be obtained in many clinical situations, without the disadvantages found with autograft. ShefaBone has demonstrated successful regenerative properties for bony defects. To our knowledge, there is no reported clinical studies on the use of SCPC material to graft a pneumatized maxillary sinus. This aim of this current study is to compare SCPC to commonly used xenograft material in an augmented maxillary sinus.

详细描述

  1. To assess the quality and quantity of the maxillary sinus bone prior to the placement of dental implants and subsequent restorations, approximately 20 patients will be randomly assigned to receive an augmentation of the maxillary sinus region using either Shefabone (synthetic bone) or Bio-Oss (xenograft).
  2. With the use of pre-operative and post-operative limited view CBCT (cone-beam computed tomography) radiography, the maxillary sinus bone density will be assessed and compared between the individuals receiving Shefabone and the individuals receiving xenograft material.
  3. Histomorphometric analysis will be used to assess, compare and contrast the quality and the quantity of the new vital bone cells generated when using these different graft materials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 20 to 75 years of age
  • at least one maxillary edentulous posterior site requiring maxillary sinus grafting and replacement with a dental implant.

排除标准

  • current smokers/tobacco users
  • are pregnant
  • have active periodontal disease
  • have uncontrolled diabetes
  • have any autoimmune disease
  • have kidney disease
  • have liver disease
  • are receiving radiation or chemotherapy
  • have any type of radiographic periapical pathology such as a periapical abscess.

结局指标

主要结局

Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements

时间窗: 5 months

Bone density will be measured by limited view CBCT radiography pre- and post-operatively.

次要结局

  • Bone Quality(5.5 months)

研究者

发起方
Mohanad Al-Sabbagh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohanad Al-Sabbagh

Professor

University of Kentucky

研究点 (2)

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