Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success (Luna)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01529801
First received: February 7, 2012
Last updated: August 6, 2013
Last verified: August 2013

February 7, 2012
August 6, 2013
February 2011
February 2015   (final data collection date for primary outcome measure)
Primary stability countertorque measures [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Resistance to countertorque measures showing primary stability and success of the implant
Primary stability countertorque measures [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Restistance to countertorque measures showing primary stability and success of the implant
Complete list of historical versions of study NCT01529801 on ClinicalTrials.gov Archive Site
Cumulative success rate [ Time Frame: 2 years ] [ 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
 
Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success
A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success

A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.

This study on dental implants with different roughened surfaces will assess its ability to resist countertorque testing at various study time points and demonstrate high success

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Partial Edentulism
  • Tooth Disease
  • Device: Osseotite Certain Tapered Group A
    Osseotite Certain Tapered with different surface roughness
    Other Name: Osseotite endosseous dental implant
  • Device: Osseotite Certain Tapered Group B
    Osseotite Certain Tapered with different surface roughness
    Other Name: Osseotite endosseous dental implant
  • Device: Osseotite Certain Tapered Group C
    Osseotite Certain Tapered with different surface roughness
    Other Name: osseotite endosseous dental implant
  • Experimental: Roughness group A
    Osseotite Certain Tapered Group A
    Intervention: Device: Osseotite Certain Tapered Group A
  • Experimental: Roughness Group B
    Osseotite Certain Tapered Group B
    Intervention: Device: Osseotite Certain Tapered Group B
  • Experimental: Roughness Group C
    Osseotite Certain Tapered Group C
    Intervention: Device: Osseotite Certain Tapered Group C
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
80
August 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients of either sex and older than 18 years of age
  • patients needing at least one dental implant 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
Chile
 
NCT01529801
3011
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Jaime Acuna, DDS Hospital San Jose
Biomet, Inc.
August 2013

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