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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01529801
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : March 31, 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 31, 2017
Study Start Date  ICMJE February 2011
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
Primary stability countertorque measures [ Time Frame: 6 weeks ]
Resistance to countertorque measures showing primary stability and success of the implant
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
Primary stability countertorque measures [ Time Frame: 6 weeks ]
Restistance to countertorque measures showing primary stability and success of the implant
Change History Complete list of historical versions of study NCT01529801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
Cumulative success rate [ Time Frame: 2 years ]
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 Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success
Official Title  ICMJE A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success
Brief Summary A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase 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
  • 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
Study Arms
  • 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
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 8, 2012)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date November 2016
Actual Primary Completion Date November 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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529801
Other Study ID Numbers  ICMJE 3011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jaime Acuna, DDS Hospital San Jose
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