5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants (PostNCT0390817)

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Dental Implant Failed; Dental Implants; Single Tooth Lost

Treatments: Device: Titanium Dental Implant; Device: Ceramic Dental Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05326880

P2022-03v1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Study Group (SG)

Experimental group

Description:

Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA

Treatment:

Device: Ceramic Dental Implant

Control Group (CG)

Active Comparator group

Description:

Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA

Treatment:

Device: Titanium Dental Implant