NCT00728754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 17, 2011

Completed
Last Updated

August 20, 2024

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

August 1, 2008

Results QC Date

June 26, 2009

Last Update Submit

August 16, 2024

Conditions

Partial EdentulismTooth Disease

Keywords

dental implantsOsseotite Certain PrevailLateralizednon-lateralizedOsseotite Certainmulticenterrandomizedclinical studypartial edentulismsingle stageearly loadingcrestal bone levelshort fixed bridge

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Osseous Integration

    four years

Study Arms (2)

Dental implant Osseotite Prevail

EXPERIMENTAL

Dental implant with lateralized design

Device: Dental implant Osseotite Prevail

Dental implant Osseotite

ACTIVE COMPARATOR

Dental implant without the lateralized design

Device: Dental implant Osseotite

Interventions

Dental implant Osseotite PrevailDEVICE

Root form titanium dental implant

Also known as: Osseotite, Prevail
Dental implant Osseotite Prevail
Dental implant OsseotiteDEVICE

root form titanium dental implant

Also known as: Osseotite
Dental implant Osseotite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Results Point of Contact

Title
Clinical Research Manager
Organization
Biomet 3i LLC
cristina.matthews@biomet.com
5617766722

Study Officials

  • Harold Baumgarten, DMD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

March 1, 2005

Primary Completion

July 1, 2007

Study Completion

April 1, 2011

Last Updated

August 20, 2024

Results First Posted

November 17, 2011

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)