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

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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

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

Condition or disease Intervention/treatment Phase
Partial Edentulism Tooth Disease Device: Osseotite Certain Tapered Group A Device: Osseotite Certain Tapered Group B Device: Osseotite Certain Tapered Group C Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
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




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


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01529801     History of Changes
Other Study ID Numbers: 3011
First Posted: February 9, 2012    Key Record Dates
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