NCT00723944

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 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

February 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 22, 2011

Completed
Last Updated

April 19, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

July 25, 2008

Results QC Date

June 26, 2009

Last Update Submit

March 24, 2022

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

    4 years

Study Arms (2)

Osseotite Certain Prevail

ACTIVE COMPARATOR

Dental implant with lateralized design

Device: Osseotite Certain Prevail

Osseotite Certain

PLACEBO COMPARATOR

Dental implant without the lateralized design

Device: Osseotite Certain

Interventions

Osseotite Certain PrevailDEVICE

Root form titanium dental implant

Also known as: Osseotite, Certain, Prevail
Osseotite Certain Prevail
Osseotite CertainDEVICE

Dental implant without the lateralized design

Also known as: Osseotite, Certain
Osseotite Certain

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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite- Universitatsmedizin Berlin

Berlin, D-10117, Germany

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

  • Anton Friedmann, DMD

    Charite- Zentrum fur Zahnmedizin

    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

July 25, 2008

First Posted

July 29, 2008

Study Start

February 1, 2005

Primary Completion

April 1, 2007

Study Completion

May 1, 2011

Last Updated

April 19, 2022

Results First Posted

November 22, 2011

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)