Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation
Condition: Atrophy of Edentulous Alveolar Ridge; Partial Edentulism
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants
      (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will
      enroll 30 active subjects who will receive two dental implants in the edentulous maxillary
      molar region. This 24-month research study will examine the clinical stability of TMDI in
      both sinus elevation and sinus augmentation environments. The proposed research lays the
      foundation for improved health care by providing surgeons and restorative dentists with data
      for determining the effects TMDI have on clinical success in less than optimal osseous
      environments. The rationale that underlies the investigation is that identification of the
      influences of trabecular surface design on implant stability in varying bone types will allow
      routine, predictable use of early loading, which, in turn, will translate into more rapid,
      economical health care, and improved psychosocial well-being of the patient. If these
      hypotheses are correct, the results are expected to provide evidence based research data to
      support early loading and immediate loading of single implants in sites of adequate bone
      volume, and density with or without the use of graft materials in sinus lift procedures. In
      addition, it is expected that these results will fundamentally advance the field of implant
      dentistry and bioengineering by providing information on the principles of the bone
      density-mechanical environment-implant stability interaction.
    

Detailed description: 
      Specific Aims

      Primary Outcome Measures:

      • The objective of this study is to allow a preliminary analysis of the resonance frequency
      values over the 12 month period, which will be the primary outcome

      Secondary Outcome Measures:

      • To assess Crestal bone level maintenance

      Study Arms Bone Augmentation: Placement of two dental implants in Sinus augmented with Puros
      Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental-
      Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the
      second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant
      stability will be determined by the initial insertion torque and RFV values at time of
      implant placement and after 1 month of healing on a monthly basis up until 12 months post
      implant placement.

      Sinus Elevation only: Placement of two dental implants as mentioned above in sinus augmented
      by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental-
      Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the
      second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant
      stability will be determined by the insertion torque and RFV values at time of implant
      placement and after 1 month of healing on a monthly basis up until 12 months post implant
      placement.
    

Intervention name(s): Two implant designs in a Sinus Bone Augmentation Procedure; Two implant designs in a Sinus Floor Elevation Procedure
Intervention type(s): Device; Device
Intervention description(s): Comparing TMDI (Zimmer Dental- Carlsbad, CA, USA) and Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA) biological behavior after a sinus bone augmentation procedure.; Comparing TMDI (Zimmer Dental- Carlsbad, CA, USA) and Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA) biological behavior after a sinus elevation only procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment