Clinical trial: Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. (NCT03908177)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? 1