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A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases (RadioCity)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723944
First Posted: July 29, 2008
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant.

Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for similar but non-lateralized Osseotite Certain implants.


Condition Intervention
Partial Edentulism Tooth Disease Device: Osseotite Certain Prevail Device: Osseotite Certain

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implanting Short-span Fixed Bridge Cases for Preservation of Crestal Bone

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit [ Time Frame: 1 year ]
    Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.


Secondary Outcome Measures:
  • Osseous Integration [ Time Frame: 4 years ]

Enrollment: 102
Study Start Date: February 2005
Study Completion Date: May 2011
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Osseotite Certain Prevail
Dental implant with lateralized design
Device: Osseotite Certain Prevail
Root form titanium dental implant
Other Names:
  • Osseotite
  • Certain
  • Prevail
Placebo Comparator: Osseotite Certain
Dental implant without the lateralized design
Device: Osseotite Certain
Dental implant without the lateralized design
Other Names:
  • Osseotite
  • Certain

Detailed Description:
This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients of either sex and any race greater than 18 years of age
  • patients for whom a decision has already been made to use dental implants for treating an existing dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are allowed, but one interior crown may be a pontic
  • patients must be physically able to tolerate conventional surgical and restorative procedures
  • patients must agree to be evaluated for each study visit, especially the yearly follow-up visit

Exclusion Criteria:

  • patients with active infection or severe inflammation in the areas intended for the implants
  • patients with more than 10 cigarette per day smoking habit
  • patients with uncontrolled diabetes mellitus
  • patients with metabolic bone disease
  • patients who have had treatment with therapeutic radiation to the head within the past 12 months
  • patients in need of allogenic bone grafting at the site of the intended study implant
  • patients who are pregnant at the screening visit
  • patients with evidence of severe para-functional habits such as bruxing or clenching
  • patients with cantilevers and more than one pontic per bridge
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723944


Locations
Germany
Charite- Universitatsmedizin Berlin
Berlin, Germany, D-10117
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Anton Friedmann, DMD Charite- Zentrum fur Zahnmedizin
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00723944     History of Changes
Other Study ID Numbers: 2302
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: June 26, 2009
Results First Posted: November 22, 2011
Last Update Posted: April 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
dental implants
Osseotite Certain Prevail
Lateralized
non-lateralized
Osseotite Certain
multicenter
randomized
clinical study
partial edentulism
single stage
early loading
crestal bone level
short fixed bridge

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Ethanol
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs