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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00723944
First received: July 25, 2008
Last updated: August 6, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723944

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

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00723944     History of Changes
Other Study ID Numbers: 2302
Study First Received: July 25, 2008
Results First Received: June 26, 2009
Last Updated: August 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biomet, Inc.:
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

ClinicalTrials.gov processed this record on August 28, 2014