Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures
Information source: Biomet, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Partial Edentulism; Tooth Disease
Intervention: High torque insertion (Procedure); Low torque insertion (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s): Armando Estefan, DMD, Principal Investigator, Affiliation: Universidad Javeriana
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.
Clinical Details
Official title: Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: primary stability countertorque measures
Secondary outcome: cumulative success rate
Detailed description:
Osseotite implants will be placed using the standard lower insertion torque forces and
compared to implants placed using higher insertion torque forces.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Universidad Javeriana, Bogota, Colombia
Additional Information
Starting date: December 2010
Last updated: July 27, 2015
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