NCT01529775

Brief Summary

This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

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

November 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

6.1 years

First QC Date

February 7, 2012

Last Update Submit

March 24, 2022

Conditions

Partial EdentulismTooth Disease

Keywords

partial edentulismdental implantsOsseotite Certain Prevail TaperedOsseotite Certain TaperedCrestal bone levelrandomizedclinical study

Outcome Measures

Primary Outcomes (1)

  • Cumulative Success Rate

    An implant will be considered successful if it is immobile when tested at various study time point

    3 years

Secondary Outcomes (1)

  • Crestal Bone Regression

    3 years

Study Arms (2)

Osseotite Certain Tapered Prevail

EXPERIMENTAL

Osseotite Certain Tapered Prevail design with platform switching feature

Device: Osseotite Certain Tapered Prevail

Osseotite Certain Tapered

ACTIVE COMPARATOR

Osseotite Certain Tapered implant with non-platform switching design

Device: Osseotite Certain Tapered

Interventions

Osseotite Certain Tapered PrevailDEVICE

Osseotite implant with platform switching feature

Also known as: Osseotite endosseous dental implant
Osseotite Certain Tapered Prevail
Osseotite Certain TaperedDEVICE

Osseotite implant with non-platform switching feature

Also known as: Osseotite endosseous dental implant
Osseotite Certain Tapered

Eligibility Criteria

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

You may qualify if:

  • patients of either sex and older than 18 years of age
  • patients needing at least one dental implant to treat partial edentulism
  • patients physically able to tolerate surgical and restorative dental procedures
  • patients agreeing to all protocol visits

You may not qualify if:

  • patients with infection or severe inflammation at the intended treatment sites
  • patients smoking greater than 10 cigarettes per day
  • patients with uncontrolled diabetes mellitus
  • patients with uncontrolled metabolic diseases
  • patients who received radiation treatment to the head in the past 12 months
  • patients needing bone grafting at the intended treatment sites
  • patients known to be pregnant at screening visit
  • patients with para-functional habits like bruxing and clenching

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Finis Terrae

Santiago, Chile

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Manuel Pavez, DDS

    Universidad Finis Terrae

    PRINCIPAL INVESTIGATOR

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

February 7, 2012

First Posted

February 9, 2012

Study Start

November 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)