Multicenter Study to Evaluate the Clinical Outcome of the OmniTaper EV Implant in Single Tooth Restorations

Implant survival rate 1 year after permanent restoration by counting implant in place 1 year after permanent restoration

This clinical study, funded by the company Dentsply Sirona, is being carried out to see if
 the newly developed tooth implant OmniTaper EV is safe, effective and functions as intended
 when replacing a lost or removed tooth. The OmniTaper EV implant is a further development of
 existing dental implants. It is made of titanium, a metal that is well tolerated by the human
 body, which has been successfully used in dental implants for more than 40 years. All
 components used in this study are available on the market, are CE-marked and will be used
 according to intended use and approved instructions.
 
 The study involves at 11 planned clinic visits including follow-up visits 6 months and
 annually until 5 years after installation of the permanent crown. after over a period of
 about five and a half years. The treatment method and healing period may vary depending on
 the individual case and treatment plan and additional visits may therefore need to be
 scheduled. The visits and procedures are the same as standard of care and no procedures will
 be done just for purpose of research.
 
 The study aims to recruit about 137 men and women from six clinics across Europe (Germany, UK
 and Switzerland) and participants can only receive one study implant each. Participation is
 entirely voluntary and participants can choose to withdraw from the study at any time,
 without giving a reason. The decision to decline or withdraw participation will not affect
 participants future treatment or care