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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:
ClinicalTrials.gov Identifier:
NCT01529801
First Posted: February 9, 2012
Last Update Posted: March 31, 2017
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.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.

Condition Intervention
Partial Edentulism Tooth Disease Device: Osseotite Certain Tapered Group A Device: Osseotite Certain Tapered Group B Device: Osseotite Certain Tapered Group C

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Primary stability countertorque measures [ Time Frame: 6 weeks ]
    Resistance to countertorque measures showing primary stability and success of the implant


Secondary Outcome Measures:
  • Cumulative success rate [ Time Frame: 2 years ]
    Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)


Enrollment: 80
Study Start Date: February 2011
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roughness group A
Osseotite Certain Tapered Group A
Device: Osseotite Certain Tapered Group A
Osseotite Certain Tapered with different surface roughness
Other Name: Osseotite endosseous dental implant
Experimental: Roughness Group B
Osseotite Certain Tapered Group B
Device: Osseotite Certain Tapered Group B
Osseotite Certain Tapered with different surface roughness
Other Name: Osseotite endosseous dental implant
Experimental: Roughness Group C
Osseotite Certain Tapered Group C
Device: Osseotite Certain Tapered Group C
Osseotite Certain Tapered with different surface roughness
Other Name: osseotite endosseous dental implant

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529801


Locations
Chile
Hospital San Jose
Santiago, Chile
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Jaime Acuna, DDS Hospital San Jose
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01529801     History of Changes
Other Study ID Numbers: 3011
First Submitted: February 7, 2012
First Posted: February 9, 2012
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
edentulism
dental implants
clinical study
randomized
Osseotite Certain Tapered
Crestal bone level

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases