5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants (NCT05326880) | Clinical Trial Compass
RecruitingNot Applicable
5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants
Germany, Hong Kong60 participantsStarted 2022-01-03
Plain-language summary
A post-market, randomized-controlled, superiority clinical study to compare medium-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
following criteria must be met for inclusion in the study:
* Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analyzed, and published.
* Patients must be males or females who are a minimum of 18 years of age.
* Patients, who have received a single tooth replacement with a study implant as per-protocol in the premolar-to-premolar area (excluding lower incisors) in the mandible and maxilla and restored with a screw retained ceramic crown.
Exclusion Criteria:
* Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability.
* Pregnancy or intention to become pregnant at any point during the study duration.
What they're measuring
1
Bone level change
Timeframe: 5 years after implant loading (final crown restoration)