Active — Not RecruitingNot Applicable

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

Germany, Switzerland, United Kingdom139 participantsStarted 2022-09-22

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Willing and able to sign and date the informed consent form. * In need of an implant in position 16 to 26 or 36 to 46 (2nd and 3rd molars are excluded), and each subject can only receive one implant. * Deemed by the PI/Subinvestigator as likely to present with an initially stable implant situation. * A stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture. * An adjacent tooth (root with natural or artificial crown) or an implant-supported crown mesially and distally. Exemption: If the planned implant is in the first molar position, an edentulous space is accepted distally Exclusion Criteria: * Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation. * Unlikely to be able to comply with clinical investigation procedures according to PI's/Subinvestigator's judgement. * Unable or unwilling to return for follow-up visits for a period of 5 years. * Severe non-compliance to CIP as judged by the PI/Subinvestigator and/or Dentsply Sirona. * Known allergy or hypersensitivity to titanium and/or stainless steel. * Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease. * Uncontrolled para-functional habits, e.g. bruxism. * Current need of any Guided Bone Regeneration (GBR) procedure in the planned implant area (gap fillin…

What they're measuring

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

Timeframe: 1 year after permanent restoration (which is estimated to occur approximately 3 months after implant placement).

Trial details

NCT IDNCT05355792

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-11-30