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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: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Partial Edentulism
Tooth Disease
 Device: Osseotite Certain Tapered Group A
Device: Osseotite Certain Tapered Group B
Device: Osseotite Certain Tapered Group C
 Phase 1

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: A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success

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: 6 weeks ] [ Designated as safety issue: Yes ]
    Resistance to countertorque measures showing primary stability and success of the implant


Secondary Outcome Measures:
  • 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)


Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529801

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

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01529801     History of Changes
Other Study ID Numbers: 3011
Study First Received: February 7, 2012
Last Updated: March 20, 2013
Health Authority: Chile: Institutional Review Board

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

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 21, 2013