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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant Failed; Dental Implants; Single Tooth Lost
• Intervention / Treatment: Device: Ceramic Dental Implant; Device: Titanium Dental Implant

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa R. Fok, Dr.; Phone Number: +852 2859 0301; Email: melfok@hku.hk
• Study Contact Backup: Name: George Pelekos, Dr.; Phone Number: +852 2859 0343; Email: george74@hku.hk

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Not yet recruiting
    • Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik
    • Contact: Frank Spitznagel, Dr.; Phone Number: +49 211 81-04440; Email: frank.spitznagel@med.uni-duesseldorf.de
• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • Recruiting
    • Clinical Research Centre, Faculty of Dentistry, The University of Hong Kong
    • Contact: Melissa R. Fok, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group (SG); Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA	Device: 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.
Active Comparator: Control Group (CG); Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	Implant survival rates 2, 3, 4, 5 years after loading: yes/no	5 years after loading
Complication/event free survival	To compare the complication/event free survival between two-piece ceramic implant and bone level titanium implant at 2, 3, 4, 5 years after loading.	5 years after loading
14 item Oral Health Impact Profile (OHIP-14)	The local language version of the OHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).	5 years after loading

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse Events will be recorded at every visit throughout the observation period	5 years
Device Deficiencies	Any device complications and deficiencies will be recorded as Device Deficiencies.	5 years

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Melissa R. Fok, Dr., The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: P2022-03v1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No