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

Not Applicable

Recruiting

• Conditions: Dental Implants; Single Tooth Lost; Dental Implant Failed
• Interventions: Device: Ceramic Dental Implant; Device: Titanium Dental Implant

• Registration Number: NCT05326880
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2022-01-03
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21
• Primary Completion: 2027-12
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group (SG)	Ceramic Dental Implant	Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA
Control Group (CG)	Titanium Dental Implant	Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA

Primary Outcome Measures

Name	Time	Method
Bone level change	5 years after implant loading (final crown restoration)	Change in crestal bone level measured by analysis of standardized peri-apical xrays 5 years after loading \[mm\].

Secondary Outcome Measures

Name	Time	Method
Implant survival	5 years after loading	Implant survival rates 2, 3, 4, 5 years after loading: yes/no
Complication/event free survival	5 years after loading	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.
14 item Oral Health Impact Profile (OHIP-14)	5 years after loading	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).

Trial Locations

Locations (2)

Clinical Research Centre, Faculty of Dentistry, the University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong

Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik; 🇩🇪 Düsseldorf, Germany