Biomechanical Informational Effect of Innovative Double or Triple Dental Abutment-implant: Case-series
Condition: Dental Implant
Study type: Observational

Summary: 
      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)].
    

Detailed description: 
      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).

      Patients This clinical investigation was designed as a pre-post case series study and is
      reported in accordance with the PROCESS (Preferred Reporting of Case Series in Surgery) and
      Consensus-based Clinical Case Reporting Guideline Development. All procedures performed in
      this study were in accordance with the ethical standards of the 1975 Declaration of Helsinki,
      revised in 2013, and received approval from the Ethics Research Committee of the Federal
      University of Minas Gerais, Brazil (CAEE: 60410222.2.0000.5149).

      The selected group of participants were informed about the procedures and signed an informed
      consent form before participating in the study. Patients were recruited from a private clinic
      in the city of Belo Horizonte - Brazil (BR), between September 2009 and January 2019.

      Participants were in good systemic health, non-diabetic and non-smokers. Prior to dental
      implant insertion surgeries, pre-surgical evaluation, detailed oral examination including
      complete periodontal examination, dental biofilm control and coronary polishing, as well as
      scaling and root planning and treatment of carious lesions (when necessary) were performed.

      Since these new abutments break important paradigms in implant dentistry, such as passive
      multiple prostheses supported on a single implant with biomechanical benefits, the
      investigators have cautiously chosen to perform only ~5 cases/year, aiming at reaching a
      minimum follow-up time of 5 years.

      This consecutive case series comprises a sample of 37 individuals/43 cases (16 men and 21
      women) with different extensions of edentulous spaces rehabilitated using DA (n=28) and TA
      (n=15) in 43 osseointegrated implants. All cases using DA and TA had occlusal function with
      their respective antagonistic pairs (natural, restored or implanted teeth). Radiographic
      exams (analogue or digital) are presented at T1 (loading after 4 months of implant insertion
      surgeries with the appropriate metal-ceramic prostheses) and at T2 (final exam) with an
      average follow-up time of 7.2 years (>3 to 12 years).

      The implants were cylindrical with internal hexagon and without surface treatment, presenting
      4.0 mm in diameter and length varying between 10 and 13 mm (Neodent® - Grupo Straumann,
      Curitiba, Paraná, Brazil).

      Clinical and laboratorial procedures

      (a) Selection of components for molding: analogues, transfers and Universal Cast to Long
      Abutment (UCLA) with metallic base in cobalt chromium compatible with the diameters and type
      of hexagon of the implant system platforms installed (all cases in this study being with
      internal hexagon); (b) molding of the osseointegrated implant using a compatible transfer and
      antagonists; (c) Confection of the manual work model; (d) use of UCLA with metallic base to
      adapt the design of DA or TA in acrylic, with individualized design according to the
      measurements and paraboloid surfaces of the DA (elliptical) and TA (hyperbolic). The use of
      angulation in DA and TA is individualized, versatile and dependent on the position of the
      implant, when necessary; (d) casting the pillars in cobalt chromium alloy and polishing.; (e)
      Confection of crowns according to the chosen material (porcelain or resins) and (f) the DA or
      TA abutments are screwed into the mouth and the crowns cemented. All laboratorial procedures
      were performed in one single dental laboratory.
    

Intervention name(s): paraboloid geometry double and triple dental abutment-implant
Intervention type(s): Device
Intervention description(s): The implants were inserted with the margin between machined and micro-rough surface at bone level. The abutment and crowns were assembled and screw retained onto the implant with a torque of 35 Ncm.
The implants were cylindrical with internal hexagon and without surface treatment, presenting 4.0 mm in diameter and length varying between 10 and 13 mm.
Acording to the manual work model measurements, DA or TA acrylic individualized design and paraboloid surfaces of the DA (elliptical) and TA (hyperbolic) had been made.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This consecutive case series comprises a sample of 37 individuals/43 cases (16 men and 21
        women) with different extensions of edentulous spaces rehabilitated using DA (n=28) and TA
        (n=15) in 43 osseointegrated implants.