Clinical trial NCT03908177: Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Implants, Single-Tooth
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2019-04-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Bone Level Change
timeFrame: 12 months after implant loading (final crown restoration)
Secondary outcomes:
measure: Implant survival
timeFrame: 12 months after loading.
measure: 14 item Oral Health Impact Profile (OHIP-14)
timeFrame: 12 months after loading.
Other outcomes:
measure: Adverse Events
timeFrame: 18 months after inclusion.
measure: Device Deficiencies
timeFrame: 18 months after inclusion.
Locations:
city: Düsseldorf
country: Germany
facility: Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong, Prince Philip Dental Hospital
city: Lisboa
country: Portugal
facility: Implantology Institute
Study officials:
References: