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

ConditionsDental Implants Single Tooth Lost Dental Implant Failed

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Study Group (SG)Experimental treatment 1 intervention

Group B: Control Group (CG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Bone level change

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

Time frame

5 years after implant loading (final crown restoration)

Secondary outcomes

Implant survival

Implant survival rates 2, 3, 4, 5 years after loading: yes/no

Time frame

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.

Time frame

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).

Time frame

5 years after loading