Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible (PrevailMulti)

January 24, 2024 updated by: ZimVie

Observational Study of Certain Prevail Implant System in Maxillary and Mandibular Regions

This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. It will also evaluate implant performance.

Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls).

Study Overview

Status

Completed

Conditions

Detailed Description

This is a prospective, observational study of patients with partial or complete edentulism treated with the Certain Prevail dental implants. Restorations will consist of single tooth replacements, short and long fixed bridges, and overdentures and full dentures. All implants are placed using a single stage approach and temporalization occurring after two months of healing (early loading). Each center will strive to enroll a total of 20 patients.

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

These will be patients who are otherwise seeking dental implant therapy and belong to the study centers' standard patient population.

Description

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:

    1. dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture.
    2. a temporary healing abutment will be placed on implant during implant placement surgery (single stage procedure).
  • 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 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 at the site of the intended study implant for augmentation purposes. Grafting for treatment of dehiscence or fenestration must have occurred at least 8 weeks prior to implant placement surgery
  • patients who are pregnant at the screening visit
  • patients with evidence of severe para-functional habits such as bruxing or clenching
  • patients with less than 6 weeks of healing time post tooth extraction at the intended treatment site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Osseous Integration
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crestal Bone Resorption
Time Frame: four years
Crestal bone level measures- changes from baseline to last study visit
four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZimVie

Investigators

  • Principal Investigator: Martin Lorenzoni, DMD, MD, PhD, Medizinische Universität Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimated)

August 6, 2008

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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