RecruitingNot ApplicableNCT05326880

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

Sponsor

The University of Hong Kong

Enrollment

60 participants

Start Date

Jan 3, 2022

Study Type

INTERVENTIONAL

Conditions

Dental Implants Dental Implant Failed Single Tooth Lost

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a 5-year follow-up study comparing two types of dental implants — one made from zirconia (ceramic) and one made from titanium — in patients who already received these implants in an earlier study. Researchers want to see how well each type holds up long-term. You may be eligible if: - You are 18 years of age or older - You previously received a dental implant (zirconia or titanium) in the original study, in the front-to-premolar area of either jaw - You are willing to attend follow-up visits and share your pseudonymized data You may NOT be eligible if: - Your condition or circumstances would prevent you from completing the study - You have a history of not following through with medical appointments or study requirements - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECeramic Dental Implant

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.

DEVICETitanium Dental Implant

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.