Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.

Study Overview
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Brief Summary
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A post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study to compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.

Detailed Description
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To compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow. Post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study investigating patients in need of dental implant therapy for single-tooth gap rehabilitation. The follow up time is1 year after final crown restoration.

Official Title
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Comparative Performance of Zirconia Tissue Level Implants vs. Titanium Bone Level Implants Placed With a Fully Digital Workflow: A Multicentre Multinational Randomized Controlled Clinical Trial

Conditions
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Dental Implants, Single-Tooth

Intervention / Treatment
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* Device: Ceramic Dental Implant
* Device: Titanium Dental Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, analysed, and published. Patients must be males or females who are a minimum of 18 years of age. Patients, who are in need of a single tooth replacement with a dental implant in the premolar-to-premolar area in the mandible or maxilla (excluding lower incisors). Presence of natural teeth on both sides of the study implant position and opposing dentition (single tooth gap). Patients with healed extraction sockets, which means that at implant surgery: Soft tissue coverage of the socket is complete; and Alveolar bone is reconsolidated (around 16 weeks after tooth extraction). Exclusion Criteria: Patients with inadequate bone volume where major bone augmentation would be required at implant location. Inadequate anatomic situation that would prevent prosthetic-driven planning based on CBCT. Presence of implants neighbouring the study implant. Patients with inadequate oral hygiene (FMPS ≥ 20%). Patients with local root remnants. Patients with inadequate wound healing capacity. Patients with incomplete maxillary and mandibular growth. Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders. Patients with drug or alcohol abuse. Patients with allergies or hypersensitivity to zirconium oxide (ZrO2), yttrium oxide (Y2O3), hafnium dioxide (HfO2), aluminium oxide (Al2O3), and titanium (Grade 4). Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders). 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. Furthermore, patients with uncontrolled periodontitis and less than 3 mm of keratinized mucosa at the day of surgery will be excluded from the study. Controlled periodontitis is defined as treated periodontitis with two or less pockets that are < 4 mm in depth or the existence of ≤ 20% bleeding on probing. If the planned implant position is the second premolar, the adjacent molar must be present. Shortened arches with missing molars are not eligible in such a case.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group (SG)<br>Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA | Device: Ceramic Dental Implant<br>* 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 after 4 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.<br>|
| Active Comparator: Control Group (CG)<br>Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA | Device: Titanium Dental Implant<br>* 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 after 4 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.<br>|

What is the study measuring?
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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 12 months after loading [mm]. | 12 months after implant loading (final crown restoration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | Implant survival rates 3, 6 months and 1 year after loading: yes/no | 12 months after loading. | 
| 14 item Oral Health Impact Profile (OHIP-14) | The local language version of the OPHIP-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). | 12 months after loading. |