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

Primary Purpose

Partial Edentulism, Tooth Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Osseotite Certain Prevail

Osseotite Certain

About this trial

This is an interventional treatment trial for Partial Edentulism focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charite- Universitatsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Osseotite Certain Prevail

Osseotite Certain

Arm Description

Dental implant with lateralized design

Dental implant without the lateralized design

Outcomes

Primary Outcome Measures

Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit

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

Full Information

NCT ID

NCT00723944

First Posted

July 25, 2008

Last Updated

March 24, 2022

Sponsor

ZimVie

1. Study Identification

Unique Protocol Identification Number

NCT00723944

Brief Title

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

Acronym

RadioCity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZimVie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Partial Edentulism, Tooth Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Osseotite Certain Prevail

Arm Type

Active Comparator

Arm Description

Dental implant with lateralized design

Arm Title

Osseotite Certain

Arm Type

Placebo Comparator

Arm Description

Dental implant without the lateralized design

Intervention Type

Device

Intervention Name(s)

Osseotite Certain Prevail

Other Intervention Name(s)

Osseotite, Certain, Prevail

Intervention Description

Root form titanium dental implant

Intervention Type

Device

Intervention Name(s)

Osseotite Certain

Other Intervention Name(s)

Osseotite, Certain

Intervention Description

Dental implant without the lateralized design

Primary Outcome Measure Information:

Title

Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit

Description

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.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Osseous Integration

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anton Friedmann, DMD

Organizational Affiliation

Charite- Zentrum fur Zahnmedizin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charite- Universitatsmedizin Berlin

City

Berlin

ZIP/Postal Code

D-10117

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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