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

NCT05326880 | Recruiting DMC

• 1 other identifier: P2022-03v1
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Dental Implants; Single Tooth Lost; Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

• Bone level change

  Change in crestal bone level measured by analysis of standardized peri-apical xrays 5 years after loading \[mm\].

  5 years after implant loading (final crown restoration)

Secondary Outcomes (3)

• Implant survival

  5 years after loading

• Complication/event free survival

  5 years after loading

• 14 item Oral Health Impact Profile (OHIP-14)

  5 years after loading

Other Outcomes (2)

• Adverse Events

  5 years

• Device Deficiencies

  5 years

Study Arms (2)

Study Group (SG)

EXPERIMENTAL

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

Device: Ceramic Dental Implant

Control Group (CG)

ACTIVE COMPARATOR

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

Device: Titanium Dental Implant

Interventions

Ceramic Dental Implant DEVICE

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.

Study Group (SG)

Titanium Dental Implant DEVICE

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.

Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik

Düsseldorf, 40225, Germany

NOT YET RECRUITING

Clinical Research Centre, Faculty of Dentistry, the University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

Study Officials

• Melissa R. Fok, Dr.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa R. Fok, Dr.

CONTACT

+852 2859 0301; melfok@hku.hk

George Pelekos, Dr.

CONTACT

+852 2859 0343; george74@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 14, 2022
• Study Start: January 3, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

DE (1); HK (1)