T3 with DCD tapered Prevail implant
DeviceT3 with DCD implant with Certain (internal) connection and platform-switch design
Other names: T3 with Nanotite, T3 with platform switch
NCT Number: NCT02161874
This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Dr. Tommie VanDeVelde, Antwerp, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
T3 with DCD implant with Certain (internal) connection and platform-switch design
Other names: T3 with Nanotite, T3 with platform switch
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design
Other names: Nanotite tapered certain, Non-platform switched
Time frame: 1 year
Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.
Time frame: 2 years
Crestal bone regression (amount of bone loss) between the two treatment groups will be compared
ZimVie
Industry
A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone
Acronym: OAK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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