跳至主要内容
临床试验/NCT02836678
NCT02836678Unknown2 期

Bone Changes in Atrophic Maxilla Treated by Split-crest Technique and Dental Implants With Platelet Rich Fibrin and Nanobone® Versus Platelet Rich Fibrin Alone; Randomized Controlled Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
40
主要终点
Horizontal bone gain in millimeters

研究概览

简要总结

The effect of adding Nanobone on horizontal bone gain in ridge splitting.

详细描述

In cases of a very narrow ridge, One of the augmentation protocols is alveolar ridge-splitting techniques (RST) or alveolar ridge expansion techniques with simultaneous implant insertion. The piezoelectric surgical devices implemented for conducting bone osteotomy through the use of micrometric ultrasonic vibrations have been widely used in recent years in maxillofacial surgery. Its biggest advantages are that it allows for cutting with micrometric sensitivity while cutting hard tissues, it offers a clear vision of the surgical site due to its cavitation effect, it does not cause any damage to the soft tissues while performing these cuts, and that the bone tissue heals more quickly and seamlessly, after the cuts made by piezosurgery device. The fully synthetic bone substitute, NanoBone® (Artoss, Rostock, Germany), which will be applied in this clinical study, is basically a nanocrystalline hydroxyapatite embedded in a silica gel matrix, achieved by means of specific sol-gel techniques. Features such as interconnecting pores on the nanoscale, the open SiOH or SiO groups of polysilicic acid, its large internal surface, and the high porosity of this biomaterial are all related to the calcification processes observed within the implantation bed. While the HA component is responsible for NanoBone osteoconductive properties, the silica component is believed to induce connective tissue formation, osteoblast proliferation, bone matrix mineralization, and calcification, thus combining osteoconductive and osteoinductive properties. This phenomenon is associated with the rearrangement of the silica matrix, which could be observed in vivo.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with an edentulous site in maxilla.
  • •Ridge width of <6mm at the edentulous site.
  • •Ridge height of >9mm at the edentulous site.
  • •Patients who are compliant to oral hygiene measures for 4 weeks.
  • •Patient consent approval and signing.

排除标准

  • •Systemic disease that contraindicates implant placement or surgical procedures.
  • •No or poor patient's compliance.
  • •History of radio or chemo-therapy.
  • •Psychological problems.
  • •Pathology at the site of intervention.
  • •Pregnancy.
  • •Insufficient crown height space or mesio-distal dimension that contradict the placement of a dental implant.

研究组 & 干预措施

Control group

Active Comparator

Ridge splitting, immediate implantand PRF.

干预措施: Ridge splitting, immediate implantand PRF. (Biological)

Test group

Experimental

Ridge splitting, immediate implant, Nanobone with PRF.

干预措施: Ridge splitting, immediate implant, Nanobone with PRF. (Biological)

结局指标

主要结局

Horizontal bone gain in millimeters

时间窗: 5 month

using Cone beam computed tomography

次要结局

  • Post-operative pain Using Numerical rating scale(2 weeks)
  • Post-operative swelling Using Descriptive 4-point scale of swelling(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maged Wadie Anis

Assistant lecturer

Cairo University

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