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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT01529801
First received: February 7, 2012
Last updated: March 30, 2017
Last verified: March 2017
February 7, 2012
March 30, 2017
February 2011
November 2016   (Final data collection date for primary outcome measure)
Primary stability countertorque measures [ Time Frame: 6 weeks ]
Resistance to countertorque measures showing primary stability and success of the implant
Primary stability countertorque measures [ Time Frame: 6 weeks ]
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 ]
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.
 
Completed
80
November 2016
November 2016   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
 
NCT01529801
3011
No
Not Provided
Plan to Share IPD: No
Zimmer Biomet
Zimmer Biomet
Not Provided
Principal Investigator: Jaime Acuna, DDS Hospital San Jose
Zimmer Biomet
March 2017

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