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A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases. (Cliffhanger)

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ClinicalTrials.gov Identifier: NCT00728754
Recruitment Status : Completed
First Posted : August 6, 2008
Results First Posted : November 17, 2011
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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Brief Summary:

This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version 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 a similar but non-lateralized Osseotite Certain implant.


Condition or disease Intervention/treatment Phase
Partial Edentulism Tooth Disease Device: Dental implant Osseotite Prevail Device: Dental implant Osseotite Not Applicable

Detailed Description:
This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive either the Osseotite Certain Lateralized (test) or the Osseotite Certain Non-lateralized (control). All implants will receive a temporary prosthesis after two months of placement. Enrollment will include up to 20 patients (approximately 60 implants per center) at each participating study center.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
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 Implant in Short-span Fixed Bridge Cases for Preservation of Crestal Bone
Study Start Date : March 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : April 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dental implant Osseotite Prevail
Dental implant with lateralized design
 Device: Dental implant Osseotite Prevail
Root form titanium dental implant
Other Names:
  • Osseotite
  • Prevail
Active Comparator: Dental implant Osseotite
Dental implant without the lateralized design
 Device: Dental implant Osseotite
root form titanium dental implant
Other Name: Osseotite


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Osseous Integration [ Time Frame: four years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers 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 visits

Exclusion Criteria:

  • patients with active infection or severe inflammation in the areas intended for implant placement
  • patients with a >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 a 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
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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): NCT00728754


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Harold Baumgarten, DMD University of Pennsylvania
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00728754    
Other Study ID Numbers: 2301
First Posted: August 6, 2008    Key Record Dates
Results First Posted: November 17, 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:
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Tooth Diseases
Stomatognathic Diseases
Ethanol
Povidone-Iodine
 Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs