Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures
This trial is active, not recruiting.
|Conditions||partial edentulism, tooth disease|
|Treatments||high torque insertion, low torque insertion|
|Start date||December 2010|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01529736, 3004|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
primary stability countertorque measures
time frame: 4 months
cumulative success rate
time frame: 1 year
Male or female participants at least 18 years old.
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
|Official title||Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures|
|Principal investigator||Armando Estefan, DMD|
|Description||Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.|
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