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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

Tracking Information
First Submitted Date  ICMJE February 7, 2012
First Posted Date  ICMJE February 9, 2012
Last Update Posted Date March 21, 2017
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
primary stability countertorque measures [ Time Frame: 4 months ]
resistance to countertorque measures showing primary stability success of implants
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01529736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
cumulative success rate [ Time Frame: 1 year ]
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures
Official Title  ICMJE Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Partial Edentulism
  • Tooth Disease
Intervention  ICMJE
  • Procedure: High torque insertion
    Osseotite implant placed with high insertion torque forces
    Other Name: Osseotite endosseous dental implant
  • Procedure: Low torque insertion
    Osseotite implant placed with low insertion torque forces
    Other Name: Osseotite endosseous dental implant
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529736
Other Study ID Numbers  ICMJE 3004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Armando Estefan, DMD Universidad Javeriana
PRS Account Zimmer Biomet
Verification Date March 2017

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