NCT01529736CompletedNot Applicable
Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ZimVie
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- primary stability countertorque measures
Study Overview
Brief Summary
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.
Detailed Description
Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High torque insertion
Experimental
High torque insertion
Intervention: High torque insertion (Procedure)
Low torque insertion
Active Comparator
Low torque insertion
Intervention: Low torque insertion (Procedure)
Outcomes
Primary Outcomes
primary stability countertorque measures
Time Frame: 4 months
resistance to countertorque measures showing primary stability success of implants
Secondary Outcomes
- cumulative success rate(1 year)
Investigators
Study Sites (1)
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