Actively Recruiting
Comparative Performance of Two-piece Zirconia Tissue Level Implants vs. Titanium Bone Level Implants Using a Fully Digital Workflow 5-year Follow-up of a Randomized Clinical Trial
Led by The University of Hong Kong · Updated on 2023-11-21
60
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the medium-term performance and safety of two types of dental implants: the Straumann PURE 2-piece Ceramic Implant made of zirconia and the Straumann Bone Level Implant made of titanium. The study aims to compare these implants using a fully digital workflow to understand their biological and technical complications, patient satisfaction, and aesthetic outcomes over a five-year period. Titanium implants have a metallic color that often requires deeper placement, which can complicate hygiene, while zirconia implants offer a color closer to natural teeth. Participants will receive either the zirconia ceramic implant or the standard titanium implant placed in healed extraction sites in the premolar-to-premolar area of the upper or lower jaw for single tooth replacement. After implant placement, prosthetic loading with a definitive crown will occur following a six-month healing period. Both groups undergo routine treatment, with the only difference being the implant material. The surgical approach follows guidelines for healed extraction sites approximately 16 weeks after tooth loss. During the five-year follow-up after implant loading, participants will attend scheduled visits where researchers will measure bone level changes, implant survival rates, and complication-free survival. Patient satisfaction and oral health impact will also be assessed using questionnaires. Data will be collected and analyzed to compare long-term implant performance and safety. Participation involves regular evaluations to monitor outcomes and ensure safety throughout the study duration.
CONDITIONS
Brief Title
5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have voluntarily signed the Informed Consent Form before any study procedures.
- Patients must be 18 years of age or older.
- Patients must have received a single tooth replacement with a study implant in the premolar-to-premolar area (excluding lower incisors) in the upper or lower jaw.
- The implant must be restored with a screw-retained ceramic crown.
- Patients must be willing and able to attend scheduled follow-up visits.
- Patients must agree that pseudonymized data will be collected, analyzed, and published.
You will not qualify if you...
- Patients with conditions or circumstances that would prevent completing study participation or interfere with study results.
- History of non-compliance or unreliability as judged by the Investigator.
- Pregnancy or intention to become pregnant during the study period.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either a zirconia or titanium dental implant placed in healed extraction sockets for single tooth replacement followed by prosthetic loading with a definitive prosthesis after 6 months healing time. Both implant types are placed using routine care procedures.
1 visit for implant placement and several follow-up visits during healing
Duration - 5 years
Participants are followed for 5 years after implant loading to evaluate implant performance, complications, and patient satisfaction with the tooth replacement.
Scheduled follow-up visits over 5 years
Trial Site Locations
Total: 2 locations
1
Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik
Düsseldorf, Germany, 40225
Not Yet Recruiting
2
Clinical Research Centre, Faculty of Dentistry, the University of Hong Kong
Hong Kong, Hong Kong, 0000
Actively Recruiting
Research Team
M
Melissa R. Fok, Dr.
G
George Pelekos, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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