NCT05355792

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

Clinical Investigation Title: An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of OmniTaper EV Implants in Extraction Sockets and Healed Ridges - A 5-year Follow-up

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Dentsply Sirona Implants and Consumables · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Jaw, Edentulous

Interventions

Type	Name	Description
DEVICE	OmniTaper EV implants	Partially edentulous subjects in need of one implant in the maxilla or mandible (2nd and 3rd molars excluded) will receive an OmniTaper EV implant system. The study will be done in accordance with standard dental practice using a one- or two-stage surgical protocol and immediate or delayed placement and/or loading.

Timeline

• Start date: 2022-09-22
• Primary completion: 2028-11-30
• Completion: 2029-01-31
• First posted: 2022-05-02
• Last updated: 2026-02-17

Locations

6 sites across 3 countries: Germany, Switzerland, United Kingdom