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临床试验/NCT05499533
NCT05499533已完成不适用

Hybrid Funnel Technique vs Conventional Drill Osteotomy, a Novel Approach for Implant Site Preparation

Luigi Canullo2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年7月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Insertion torque curve

研究概览

简要总结

Hybrid Funnel Technique arises from the union of subtractive and non-subtractive techniques for implant site preparation. Hybrid funnel technique is performed with specially designed drills and osteotome. the aim of the study is to examine marginal bone level and implant stability of implants inserted with two different techniques for the surgical implant site preparation.

详细描述

Overtime several osteotomy techniques were described in literature for surgical implant site preparation and there is a clear dichotomy between expansive and ablative techniques.

The ablative techniques imply the preparation of the implant socket by removing bone: drill osteotomy and ultrasonic osteotomy. Expansive technique for osteotomy has recently been proposed: the osseodensification. Osseodensification, a non-subtractive instrumentation method, involves the use of specific drills or manual osteotomes which determine an expansion of the implant site without bone removal and bone fragments compaction on the walls of implant socket.The aim of the present study is to propose a new approach for the implant site preparation that combines ablative and expansive techniques. The technique proposed is called hybrid funnel techniqueAlthough a variety of techniques are available for implant site preparation, the hypothesis is that Hybrid Funnel technique will be positively adopted to perform osteotomy, exploiting the cancellous bone elastic properties to stabilize the implant and avoiding to stress the cortical area. Primary objectives are to compare hybrid funnel technique and traditional technique on different bone densities and to examine Marginal Bone Level torque insertion value and Implant stability.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient needing for post-extraction implant supported restoration in the mandibular or maxillary area
  • ASA 1 E ASA 2
  • Subject is 30-85 years old
  • Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
  • Patients that are willing to sign an informed consent and participate in a clinical study

排除标准

  • Absence Type 1-2 post extraction sites
  • Patient ASA 3 or 4
  • Any sites where an implant already failed sites
  • Untreated Periodontitis
  • Allergy declared to one or more medicaments to be used during treatment
  • Pregnancy (confirmed by verbal inquiry)

结局指标

主要结局

Insertion torque curve

时间窗: During implant placement (T0 baseline)

The Insertion torque data were recorded and exported as a curve The torque curve records the amount of energy that was needed for arrive at the positioning of the implantunit of measurement of torque is Newton centimeter (Ncm)

Implant stability

时间窗: 2 months after implant placement

check implant stability using resonant frequency analysis (RFA)

Marginal bone loss

时间窗: 12 months after implant placement

Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost

次要结局

未报告次要终点

研究者

发起方
Luigi Canullo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luigi Canullo

principal investigator

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

研究点 (2)

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