Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases
This trial is active, not recruiting.
|Conditions||partial edentulism, tooth disease|
|Treatments||implant with new abutment connection, nanotite certain tapered implant|
|Start date||July 2011|
|End date||December 2016|
|Trial size||49 participants|
|Trial identifier||NCT01529814, 3012|
Integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design than for the control implants.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Primary stability countertorque measures
time frame: 2 months
Cumulative success rate
time frame: 2 years
Male or female participants at least 18 years old.
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
|Official title||A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Early|
|Principal investigator||Carlos Montoya, DDS|
|Description||In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by countertorque testing and cumulative success rate in cases that are loaded early|
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