Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System (OAK)
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|ClinicalTrials.gov Identifier: NCT02161874|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : January 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Partial Edentulism Tooth Disease||Device: T3 with DCD tapered Prevail implant Device: Nanotite Certain tapered implant||Not Applicable|
This prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. Implant sites will be randomly assigned to receive either a test (T3 implant) or control (Nanotite Certain Tapered implant) with an 80:20 (test:control) randomization ratio.
All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter.
Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||July 2020|
Experimental: T3 with DCD tapered implant
T3 with DCD tapered prevail implant
Device: T3 with DCD tapered Prevail implant
T3 with DCD implant with Certain (internal) connection and platform-switch design
Active Comparator: Nanotite certain tapered implant
Nanotite Certain tapered implant
Device: Nanotite Certain tapered implant
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design
- Cumulative success rate [ Time Frame: 1 year ]Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.
- Crestal bone changes [ Time Frame: 2 years ]Crestal bone regression (amount of bone loss) between the two treatment groups will be compared
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161874
|Dr. Tommie VanDeVelde|
|Dr. Dominique Caspar|
|Les Bains, France|
|Dr. Felix Hanssler|
|Dr. Nicholas Lewis|
|London, United Kingdom|
|Principal Investigator:||Nicholas Lewis, DMD||Eastman Dental Hospital|