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临床试验/NCT06127576
NCT06127576已完成不适用

Biomechanical Informational Effect of Innovative Double or Triple Dental Abutment-implant: Case-series

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2009年9月1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
55
试验地点
1
主要终点
marginal bone level

研究概览

简要总结

Objective: The aim of this case series study is to present the rationality and scientific evidence of a new design for a Double and Triple abutment with their specific new concept of Biodynamic Optimized Peri-implant Tissue (BOPiT).

Methods: The innovative design of these abutments with a paraboloid geometry was based on BOPiT, simultaneously involving the principles of mechanobiology, biotensegrity, and mechanotransduction. Thus, individuals rehabilitated with different extents of edentulous spaces using the innovative double and triple abutments on osseointegrated dental implants are included in this case series. The double and triple abutments support 2 or 3 dental crowns on a single implant, respectively. Clinic and radiographic examinations are presented at T1 (loading after 4 months of the implant insertion surgeries with the appropriate metalloceramic prostheses) and T2 [final examination with a follow-up time ≥ 3 to 12 years (average of 7.2 years)].

详细描述

Conception and design of the Double Abutment (DA) and Triple Abutment (TA): Scientific Rationality Traditional abutments are generally cylindrical nowadays, having two curved edges at the base and an edge that connects the two vertices on the side face (total of 3 edges) considering its strength as a unit, while the new DA and TA features a paraboloid geometric design along its entire length.

The paraboloid is a mathematical equation that generates quadric surfaces of two types: elliptic and hyperbolic. The elliptic paraboloid is shaped like an oval-shaped cup and can have a maximum or minimum point. In an appropriate coordinate system, with the three axes x, y and z, it can be represented by the equation: z/c=x2 /a2 + y2 /b2, where a and b are constants that determine the degree of curvature in the x-z and y-z planes, respectively (an elliptic paraboloid opens upwards). The hyperbolic paraboloid, or hypar, is a doubly ruled surface (composed of multiple lines, whose union forms the surface itself), usually saddle-shaped. Its coordinated system is also based on three axes, manifested in the equation: z/c = y2/b2 - x2/a2. For c>0, i.e., a hyperbolic paraboloid that opens downward along the x-axis and along the y-axis (i.e., the parabola in the x=0 plane is open upward and the parabola in the y=0 plane opens downward).

The design of DA (elliptical paraboloid) and TA (hyperbolic paraboloid) allows high stiffness with reduced bending stresses and equalization of forces. Additionally, TA hyperbolic paraboloid structures are the most complex and possess a unique combination of structural and architectural properties, resultant from its double curvature, concave convex and suited to carry the in-plane shear forces and transmit uniform eccentric axial forces to the other members of the system. Vectorial loads are minimized, preventing the traditional axis of transverse coordinates that imply early bone loss in the implant abutment connection area. These designs represent the interaction that exists between all biological phenomena and mathematics.

The new abutments are multiple mechanical load organizers, and support 2 (DA) or 3 (TA) crowns on each abutment, with an innovative geometric design that is totally passive (no welds), resulting from mathematical and physical conformations coupled in geometric vector models.

DA and TA are protected by the following patents: "Pilar geminado sobre implante osseointegrado e corretivo extensor compensatório de inclinações" [Double abutment on osseointegrated implant and compensating inclination extensor corrector (PI BR 0505827-9)]; "Splint abutment over osseointegrated implant and compensatory slanted coping" (United States Patent 9039416 and Canadian Patent No. 2,630,592); "System of triple abutments with connect (United States Patent 11,701,206); "Sistema de pilares trigeminados e múltiplos sobre implantes osseointegrados e guias direcionadores" [Triple and multiple abutments on osseointegrated implants and guide directors (PI BR 0800298-3, Brazil)]. All patents belong to the Institute of Technology and Research (Instituto de Tecnologia e Pesquisa -, Belo Horizonte, Minas Gerais, Brazil).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • •good systemic health
  • •non-diabetic
  • •non-smokers
  • •implant replacement need

排除标准

  • •former and current smokers
  • •periodontitis

结局指标

主要结局

marginal bone level

时间窗: up to 12 years of follow-up

differences in marginal bone level detected by radiographic examinations

次要结局

未报告次要终点

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando O Costa

Titular Professor

Federal University of Minas Gerais

研究点 (1)

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