Clinical trial NCT05326880: 5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implants
Single Tooth Lost
Dental Implant Failed
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Dental implants are a key modality for tooth replacement. Titanium dental implants have been the mainstay of dental implants as it osseointegrate well. Titanium has a silver gray metallic color and therefore, to hide its presence and enhance the aesthetic appearance, the implant is usually placed deeper into the bone tissue and the gums. This has negative consequences since it becomes more difficult to keep the interface between the dental implant and the crown free from bacterial plaque and inflammation. The use of zirconia（a base form of metal with similar properties of titanium in terms of osseointegration) has attracted a lot of interest because of its color that is similar to the one of natural teeth.This study will hence compare the long term performance of standard 4th generation dental implants made of titanium with a second generation zirconia dental implant. The study will evaluate the occurence of biological and technical complications; patient satisfaction and with the aesthetics of the tooth replacement over time.

Eligibility 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.

Primary outcomes:
measure: Bone level change
timeFrame: 5 years after implant loading (final crown restoration)
Secondary outcomes:
measure: Implant survival
timeFrame: 5 years after loading
measure: Complication/event free survival
timeFrame: 5 years after loading
measure: 14 item Oral Health Impact Profile (OHIP-14)
timeFrame: 5 years after loading
Other outcomes:
measure: Adverse Events
timeFrame: 5 years
measure: Device Deficiencies
timeFrame: 5 years
Locations:
city: Düsseldorf
country: Germany
facility: Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik
city: Hong Kong
country: Hong Kong
facility: Clinical Research Centre, Faculty of Dentistry, the University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Melissa R. Fok, Dr.
role: PRINCIPAL_INVESTIGATOR
References: