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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529736
First Posted: February 9, 2012
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
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.

Condition Intervention
Partial Edentulism Tooth Disease Procedure: High torque insertion Procedure: Low torque insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • primary stability countertorque measures [ Time Frame: 4 months ]
    resistance to countertorque measures showing primary stability success of implants


Secondary Outcome Measures:
  • cumulative success rate [ Time Frame: 1 year ]
    Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)


Enrollment: 60
Study Start Date: December 2010
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High torque insertion
High torque insertion
Procedure: High torque insertion
Osseotite implant placed with high insertion torque forces
Other Name: Osseotite endosseous dental implant
Active Comparator: Low torque insertion
Low torque insertion
Procedure: Low torque insertion
Osseotite implant placed with low insertion torque forces
Other Name: Osseotite endosseous dental implant

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529736


Locations
Colombia
Universidad Javeriana
Bogota, Colombia
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Armando Estefan, DMD Universidad Javeriana
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01529736     History of Changes
Other Study ID Numbers: 3004
First Submitted: February 7, 2012
First Posted: February 9, 2012
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
edentulism
dental implants
early loading
crestal bone level
high torque insertion
low torque insertion
randomized
Osseotite
clinical study

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases