5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants
Comparative Performance of Two-piece Zirconia Tissue Level Implants vs. Titanium Bone Level Implants Placed With a Fully Digital Workflow - 5-year Follow up of a Randomized Clinical Trial
The University of Hong Kong
60 participants
Jan 3, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria2
- 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.
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Interventions
The ceramic implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading with definitive prosthesis after 6 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.
The titanium implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading with definitive prosthesis after 6 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05326880