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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group (SG) | Experimental | Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA |
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| Control Group (CG) | Active Comparator | Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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. |
| 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. |
Inclusion Criteria:
following criteria must be met for inclusion in the study:
Exclusion Criteria:
All
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa R. Fok, Dr. | Contact | +852 2859 0301 | melfok@hku.hk | |
| George Pelekos, Dr. | Contact | +852 2859 0343 | george74@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Melissa R. Fok, Dr. | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik | Not yet recruiting | Düsseldorf | 40225 | Germany |
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| 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. |
|
| 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 |
| 5 years |
| Clinical Research Centre, Faculty of Dentistry, the University of Hong Kong | Recruiting | Hong Kong | 0000 | Hong Kong |
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