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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor 2 versions Re-verified since Jan 9, 2025, no change to tracked fieldsv10-v11
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 137 to confirmed 139
    • Site details revised at 6 of 6 sites
    v9
  3. Minor Re-verified, no change to tracked fieldsv8
  4. Minor Eligibility criteria expanded, about 4 wordsv7
  5. Minor Study sites revised (6)v6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Start date: Sep 1, 2022 to Sep 22, 2022
    • Site details revised at 3 of 6 sites
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 10, 2022 to Sep 1, 2022
    • Site details revised at 6 of 6 sites
    v4
  3. Minor Start date: Sep 1, 2022 to Sep 10, 2022v3
  4. Notable Start date: Jun 1, 2022 to Sep 1, 2022
    • Study sites: 5 to 6
    • Primary completion date: Aug 31, 2028 to Nov 30, 2028
    • Study completion date: Oct 31, 2028 to Jan 31, 2029
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05355792
Lead Sponsor Dentsply Sirona Implants and Consumables
Conditions
(from sponsor)
Jaw, Edentulous
Related terms Jaw, Edentulous
Enrollment 139 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov