Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05326880

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Long-term Monitoring

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

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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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