NCT02404649

Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation

A Prospective Clinical Trial Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Staged Sinus Floor Elevation Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atrophy of Edentulous Alveolar Ridge
• Partial Edentulism

Interventions

Type	Name	Description
DEVICE	Two implant designs in 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 bone augmentation procedure.
DEVICE	Two implant designs in a Sinus Floor Elevation 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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-10-01
• Completion: 2017-12-01
• First posted: 2015-03-31
• Last updated: 2020-07-22
• Results posted: 2016-10-06

Locations

1 site across 1 country: United States