Comparing two types of dental implants over five years

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a post-market, randomized-controlled trial designed to compare the medium-term performance and safety of two types of dental implants: the Straumann PURE 2-piece Ceramic Implant and the Straumann Bone Level Implant. It aims to evaluate the occurrence of biological and technical complications, as well as patient satisfaction and aesthetic outcomes over a five-year period. Participants will receive either a ceramic or titanium implant for single tooth replacement in the premolar-to-premolar area, and their progress will be monitored through scheduled follow-up visits. The study utilizes a fully digital workflow to enhance the accuracy and efficiency of the implant procedures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Research Centre, Faculty of Dentistry, the University of Hong Kong
  Hong Kong, Hong Kong Recruiting
• Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik
  Düsseldorf, Germany Not yet recruiting

Study contacts

• Principal investigator: Melissa R. Fok, Dr. — The University of Hong Kong
• Study coordinator: Melissa R. Fok, Dr.
• Email: melfok@hku.hk
• Phone: +852 2859 0301

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.