Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national… (NCT03908177) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.
Germany, Hong Kong, Portugal121 participantsStarted 2019-09-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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, we…
What they're measuring
1
Bone Level Change
Timeframe: 12 months after implant loading (final crown restoration)