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

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ClinicalTrials.gov Identifier: NCT01529736
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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 or disease Intervention/treatment Phase
Partial Edentulism Tooth Disease Procedure: High torque insertion Procedure: Low torque insertion Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
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




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


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01529736     History of Changes
Other Study ID Numbers: 3004
First Posted: February 9, 2012    Key Record Dates
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