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Clinical Trials in Germany / NCT05326880
Recruiting Not applicable

5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants

NCT05326880 · tracked via the Priya Life Science Germany tracker
Sponsor
The University of Hong Kong
Phase
Not applicable
Started
2022-01-03
Last updated
2023-11-21

Condition(s) studied

Dental ImplantsSingle Tooth LostDental Implant Failed

Investigational drug(s) / intervention(s)

Ceramic Dental ImplantTitanium Dental Implant

Ceramic Dental Implant: The ceramic implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading with definitive prosthesis after 6 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.

Titanium Dental Implant: The titanium implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading with definitive prosthesis after 6 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05326880 on ClinicalTrials.gov ↗ ← All trials in Germany