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

Primary Purpose

Partial Edentulism, Tooth Disease

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Osseotite Certain Tapered Group A
Osseotite Certain Tapered Group B
Osseotite Certain Tapered Group C
Sponsored by
ZimVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Edentulism focused on measuring edentulism, dental implants, clinical study, randomized, Osseotite Certain Tapered, Crestal bone level

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital San Jose

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Roughness group A

Roughness Group B

Roughness Group C

Arm Description

Osseotite Certain Tapered Group A

Osseotite Certain Tapered Group B

Osseotite Certain Tapered Group C

Outcomes

Primary Outcome Measures

Primary stability countertorque measures
Resistance to countertorque measures showing primary stability and success of the implant

Secondary Outcome Measures

Cumulative success rate
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Full Information

First Posted
February 7, 2012
Last Updated
March 24, 2022
Sponsor
ZimVie
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1. Study Identification

Unique Protocol Identification Number
NCT01529801
Brief Title
Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success
Acronym
Luna
Official Title
A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZimVie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Edentulism, Tooth Disease
Keywords
edentulism, dental implants, clinical study, randomized, Osseotite Certain Tapered, Crestal bone level

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roughness group A
Arm Type
Experimental
Arm Description
Osseotite Certain Tapered Group A
Arm Title
Roughness Group B
Arm Type
Experimental
Arm Description
Osseotite Certain Tapered Group B
Arm Title
Roughness Group C
Arm Type
Experimental
Arm Description
Osseotite Certain Tapered Group C
Intervention Type
Device
Intervention Name(s)
Osseotite Certain Tapered Group A
Other Intervention Name(s)
Osseotite endosseous dental implant
Intervention Description
Osseotite Certain Tapered with different surface roughness
Intervention Type
Device
Intervention Name(s)
Osseotite Certain Tapered Group B
Other Intervention Name(s)
Osseotite endosseous dental implant
Intervention Description
Osseotite Certain Tapered with different surface roughness
Intervention Type
Device
Intervention Name(s)
Osseotite Certain Tapered Group C
Other Intervention Name(s)
osseotite endosseous dental implant
Intervention Description
Osseotite Certain Tapered with different surface roughness
Primary Outcome Measure Information:
Title
Primary stability countertorque measures
Description
Resistance to countertorque measures showing primary stability and success of the implant
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Cumulative success rate
Description
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Acuna, DDS
Organizational Affiliation
Hospital San Jose
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Jose
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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