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: October 17, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 25, 2008

Last Updated Date

October 17, 2011

Start Date ^ICMJE

February 2005

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

crestal bone and periodontal outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00723944 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Osseous Integration [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Osseous integration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implanting Short-span Fixed Bridge Cases for Preservation of Crestal Bone

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Partial Edentulism
Tooth Disease

Intervention ^ICMJE

Device: Osseotite Prevail Certain Prevail
Root form titanium dental implant
Other Names:
- Osseotite
- Certain
- Prevail
Device: Osseotite Certain
Dental implant without the lateralized design
Other Names:
- Osseotite
- Certain

Study Arm (s)

Active Comparator: Osseotite Certain Prevail
Dental implant with lateralized design

Intervention: Device: Osseotite Prevail Certain Prevail
Placebo Comparator: Osseotite Certain
Dental implant without the lateralized design

Intervention: Device: Osseotite Certain

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

102

Completion Date

May 2011

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00723944

Other Study ID Numbers ^ICMJE

2302

Has Data Monitoring Committee

Yes

Responsible Party

Biomet, Inc.

Study Sponsor ^ICMJE

Biomet, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anton Friedmann, DMD

Charite- Zentrum fur Zahnmedizin

Information Provided By

Biomet, Inc.

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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