Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation
This trial is active, not recruiting.
|Conditions||partial edentulism, tooth disease|
|Treatments||new abutment connection implant, nanotite certain tapered implant|
|Start date||August 2011|
|End date||December 2016|
|Trial size||49 participants|
|Trial identifier||NCT01529879, 3014|
Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
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 Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone|
|Principal investigator||Jorge Arango, 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 lack of implant mobility and lack of bone loss obtained at various study time points|
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