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Clinical Trials/NCT01529801
NCT01529801
Completed
Not Applicable

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

ZimVie1 site in 1 country80 target enrollmentFebruary 2011
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ConditionsPartial EdentulismTooth Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Partial Edentulism
Sponsor
ZimVie
Enrollment
80
Locations
1
Primary Endpoint
Primary stability countertorque measures
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
November 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ZimVie
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Primary stability countertorque measures

Time Frame: 6 weeks

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

Secondary Outcomes

  • Cumulative success rate(2 years)

Study Sites (1)

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