Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures

Overview

Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.

Full Title of Study: “Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 2016

Detailed Description

Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.

Interventions

  • Procedure: High torque insertion
    • Osseotite implant placed with high insertion torque forces
  • Procedure: Low torque insertion
    • Osseotite implant placed with low insertion torque forces

Arms, Groups and Cohorts

  • Experimental: High torque insertion
    • High torque insertion
  • Active Comparator: Low torque insertion
    • Low torque insertion

Clinical Trial Outcome Measures

Primary Measures

  • primary stability countertorque measures
    • Time Frame: 4 months
    • resistance to countertorque measures showing primary stability success of implants

Secondary Measures

  • cumulative success rate
    • Time Frame: 1 year
    • Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Participating in This Clinical Trial

Inclusion Criteria

  • patients of either sex and older than 18 years of age – patients needing a minimum of 3 implants 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ZimVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Armando Estefan, DMD, Principal Investigator, Universidad Javeriana

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