跳至主要内容
临床试验/NCT04331028
NCT04331028撤回不适用

Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets

Rui Figueiredo1 个研究点 分布在 1 个国家开始时间: 2014年10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
撤回
发起方
试验地点
1
主要终点
Histomorphometry

研究概览

简要总结

The extracorporeal shock wave therapy (ESWT) has shown good results in bones and soft tissues of the lower and upper extremities such as: pseudoarthrosis, promoting bone formation of delayed or nonunion fractures, tendinopathies, fascitis and even in vascular pathologies.

The investigators main hypothesis is that the application of extracorporeal shock wave therapy (ESWT) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth should prevent further residual alveolar bone resorption and will enhance vital bone formation.

The investigators null hypothesis is that applying extracorporeal shock wave therapy (ESWT) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth has no influence in the alveolar bone remodeling process.

Therefore, the investigators main objective is to evaluate the efficacy of the ESWT in the prevention of alveolar bone resorption after an extraction with a volumetric exam through computer tomographies (CT) analysis. The investigators secondary objective is to determine the effect of ESWT in the internal bone healing process of these postextraction alveolar sockets, measuring the bone density in the CT (Hounsfield units) and the histomorphometric exam.

Methodology: randomized and open clinical trial with 20 patients (10 per group: with or without ESWT treatment) that comply the inclusion and exclusion criteria. In the first appointment the tooth extraction will be performed, while in the second visit (two weeks later), CT scan will be made to all patients and ESWT will be applied in the experimental group. Finally, in the third visit (ten weeks later), a new CT scan will be done and an implant will be placed in the zone taking previously a bone sample with a trephine bur.

The expected results are an improvement in the quantity and quality of the alveolar bone before the implant placement.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ages between 18 - 65 years old.
  • •Non-smoking patients.
  • •Patients committed to rehabilitate the extraction socket with an implant.
  • •Lack of pathology in the surrounding area.
  • •Cooperative patients with serious commitment to follow the investigator's postoperative visits, who must sign the informed consent.
  • •Patients that need a conventional anterior maxillary single tooth extraction.

排除标准

  • •Systemic illnesses (ASA III or above) that could contraindicate a surgical intervention or modify the wound healing.
  • •Patients with cardiopathies.
  • •Patients taking hormones, calcium or oral or endovenous bisphosphonates.
  • •Patients with uncontrolled periodontitis / periimplantitis.
  • •Patients with implant/s in the upper maxilla.
  • •Surgical extractions that require rising a flap or ostectomy.
  • •Bone defects larger of 2 mms in alveolar sockets due to cortical bone defect or resorption, fenestrations or/and dehiscences.
  • •Guided bone regeneration need.
  • •Periapical radiolucency larger than 2-3 mms.

研究组 & 干预措施

Shockwave therapy

Experimental

After dental extraction, a shockwave therapy will be applied to the area.

干预措施: Shockwave therapy (Device)

Control

No Intervention

After dental extraction, no treatment will be applied

结局指标

主要结局

Histomorphometry

时间窗: 10 weeks

Bone volume

时间窗: 10 weeks

Measured in Cone Beam Computer Tomography

次要结局

未报告次要终点

研究者

发起方
Rui Figueiredo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rui Figueiredo

Associate Professor; IDIBELL researcher

University of Barcelona

研究点 (1)

Loading locations...

相似试验