Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures (Pegasus)

March 24, 2022 updated by: ZimVie

Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures

Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Colombia
      • Bogota, Colombia
        • Universidad Javeriana

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients of either sex and older than 18 years of age
  • patients needing a minimum of 3 implants to treat partial edentulism
  • patients physically able to tolerate surgical and restorative dental procedures
  • patients agreeing to all protocol visits

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High torque insertion
Procedure: High torque insertion
Osseotite implant placed with high insertion torque forces
Other Names:
  • Osseotite endosseous dental implant
Active Comparator: Low torque insertion
Procedure: Low torque insertion
Osseotite implant placed with low insertion torque forces
Other Names:
  • Osseotite endosseous dental implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary stability countertorque measures
Time Frame: 4 months
resistance to countertorque measures showing primary stability success of implants
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative success rate
Time Frame: 1 year
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
1 year

Collaborators and Investigators

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

Sponsor

ZimVie

Investigators

  • Principal Investigator: Armando Estefan, DMD, Universidad Javeriana

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

December 1, 2010

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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