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

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

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.

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.

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.