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

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.

Inclusion criteria

• • The subject male or female between 21-75 years of age and has:

• The ability to understand and sign the informed consent prior to starting the study
• The ability and willingness to comply with all study requirements
• Adequate oral hygiene
• The presence of a atrophic, pneumatized, partially edentulous maxilla requiring a lateral approach technique
• Adequate bone volume to accommodate the planned endosseous dental implant (e.g. sufficient height of bone (5 mm or greater) such that the implant would achieve primary stability, and sufficient width that the implant could be placed within the confines of the existing bone without dehiscence or fenestration. The only implant length utilized in this protocol will be a 10 mm long TMDI (Zimmer)
• Existing teeth that are healthy and adequately restored, and desired a fixed restoration on implants
• had a negative pregnancy test within one week prior to surgery, if of childbearing potential.

Exclusion criteria

• Subjects who have smoked cigarettes or chewed tobacco within the past year
• History of alcoholism or drug abuse within the past 5 years
• Subjects with Severe bruxing or clenching habits
• Untreated periodontitis
• Subjects at undue risk for an outpatient surgical procedure
• Subjects with the presence of residual roots at the implant site
• Subjects with history of site development (extensive bone augmentation) at the implant site in the past 4 months
• Placement of implant in an extraction site that had been healing for less than 2 month
• Presence of local inflammation or mucosal diseases such as lichen planus
• Subjects with uncontrolled diabetes (defined as HA1c > 7.0 percent)
• Subjects with current hematologic disorder or chronic use of Coumadin (or similar) anti-coagulant therapies
• Subjects with history of leukocyte dysfunction and deficiencies
• Subjects with Metabolic bone disorders
• Subjects with history of renal failure
• Subjects with history of liver disease
• Immunocompromised Subjects having HIV, RA, SLE or other collagen vascular disorders
• Subjects with chronic corticosteroid use
• Subjects undergoing chemotherapy
• Subjects with a history of use of IV-based bisphosphonates
• Subjects with history of radiation treatment to the head or neck
• Subjects requiring grafting of bone or mucosal tissue at the time of implant placement, which would require submersion of the implant during the healing period
• Subjects using of any investigational drug or device within the 30 day period immediately prior to implant surgery
• Pregnant women or women intending to become pregnant during this study period.
• Subjects requiring submersion of implants for esthetic reasons