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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: November 8, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures

Resource links provided by NLM:

MedlinePlus related topics: Tooth Disorders
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

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


Secondary Outcome Measures:
  • 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)


Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2013 (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 Names:
  • Osseotite endosseous dental implant
  • High torque insertion
Active Comparator: Low torque insertion
Low torque insertion
 Procedure: Low torque insertion
Osseotite implant placed with low insertion torque forces
Other Names:
  • Osseotite endosseous dental implant
  • Low torque insertion

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529736

Locations
Colombia
Universidad Javeriana
Bogota, Colombia
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Maria B Ferro, DMD Universidad Javeriana
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01529736     History of Changes
Other Study ID Numbers: 3004
Study First Received: February 7, 2012
Last Updated: November 8, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Biomet, Inc.:
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

ClinicalTrials.gov processed this record on May 16, 2013