Partial Edentulism Clinical Trial
Official title:
A Prospective Clinical Trial Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Staged Sinus Floor Elevation Procedures
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00713206 -
Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
|
N/A | |
Completed |
NCT03283241 -
Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism
|
N/A | |
Completed |
NCT00728884 -
Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible
|
||
Completed |
NCT01529775 -
Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered
|
N/A | |
Completed |
NCT03934853 -
Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System
|
N/A | |
Completed |
NCT03769376 -
Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts
|
N/A | |
Completed |
NCT01953991 -
OHQoL With Removable Partial Dentures; a Pilot Study
|
N/A | |
Completed |
NCT02387970 -
Immediate or Delayed Provisionalization in Posterior Healed Sites
|
N/A | |
Completed |
NCT02158377 -
TM vs TSV Implants Loaded Early vs Conventional in Anterior and Posterior Areas
|
N/A | |
Completed |
NCT01324778 -
Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed
|
N/A | |
Terminated |
NCT02188212 -
Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD
|
N/A | |
Completed |
NCT00728754 -
A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.
|
N/A | |
Completed |
NCT00728962 -
A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.
|
||
Active, not recruiting |
NCT03558347 -
CF41102 5-year Clinical Evaluation of Conelog® Implant With 7 mm Length
|
N/A | |
Withdrawn |
NCT02590861 -
Improving Oral Health Function With Implant Supported Partial Dentures
|
N/A | |
Completed |
NCT02507661 -
Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes
|
Phase 4 | |
Completed |
NCT02703168 -
Long-term Performance of SLActive Implants After Immediate or Early Loading
|
N/A | |
Completed |
NCT01529814 -
Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases
|
N/A | |
Completed |
NCT00782171 -
Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface
|
Phase 4 | |
Enrolling by invitation |
NCT04140006 -
Efficacy of Antiresorptive and Bone Forming Material on Dental Implants
|
Phase 1/Phase 2 |