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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01529736
First received: February 7, 2012
Last updated: January 16, 2014
Last verified: January 2014

February 7, 2012
January 16, 2014
December 2010
July 2014   (final data collection date for primary outcome measure)
primary stability countertorque measures [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
resistance to countertorque measures showing primary stability success of implants
Same as current
Complete list of historical versions of study NCT01529736 on ClinicalTrials.gov Archive Site
cumulative success rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Same as current
Not Provided
Not Provided
 
Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Partial Edentulism
  • Tooth Disease
  • Procedure: High torque insertion
    Osseotite implant placed with high insertion torque forces
    Other Names:
    • Osseotite endosseous dental implant
    • High torque insertion
  • Procedure: Low torque insertion
    Osseotite implant placed with low insertion torque forces
    Other Names:
    • Osseotite endosseous dental implant
    • Low torque insertion
  • Experimental: High torque insertion
    High torque insertion
    Intervention: Procedure: High torque insertion
  • Active Comparator: Low torque insertion
    Low torque insertion
    Intervention: Procedure: Low torque insertion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT01529736
3004
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Armando Estefan, DMD Universidad Javeriana
Biomet, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP