Comparing two types of dental implants over five years
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
This study is testing whether a new ceramic dental implant works better and is safer than a traditional titanium implant for replacing single teeth over five years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 2 sites (Düsseldorf and 1 other locations) |
| Trial ID | NCT05326880 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require a single tooth replacement in the premolar-to-premolar area and can comply with study protocols.
Not a fit: Patients with conditions that may interfere with study participation or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which type of dental implant offers better long-term performance and patient satisfaction.
How similar studies have performed: Previous studies have shown varying success with different types of dental implants, but this specific comparison of zirconia versus titanium implants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Düsseldorf and 1 other locations
- Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik — Düsseldorf, Germany (Not_yet_recruiting)
- Clinical Research Centre, Faculty of Dentistry, the University of Hong Kong — Hong Kong, Hong Kong (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.