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

NCT03908177 | Completed

• 1 other identifier: CR2017-04
• Study Type: interventional
• Target: 121
• Locations: 3 countries
• Sites: 3

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.

Conditions

Dental Implants, Single-Tooth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Implant survival

  12 months after loading.

• 14 item Oral Health Impact Profile (OHIP-14)

  12 months after loading.

Other Outcomes (2)

• Adverse Events

  18 months after inclusion.

• Device Deficiencies

  18 months after inclusion.

Study Arms (2)

Study Group (SG)

EXPERIMENTAL

Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA

Device: Ceramic Dental Implant

Control Group (CG)

ACTIVE COMPARATOR

Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA

Device: Titanium Dental Implant

Interventions

Ceramic Dental Implant DEVICE

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.

Study Group (SG)

Titanium Dental Implant DEVICE

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.

Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Straumann AG: lead
• Avania: collaborator

Study Sites (3)

Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik

Düsseldorf, 40225, Germany

Location

The University of Hong Kong, Prince Philip Dental Hospital

Hong Kong, Hong Kong

Location

Implantology Institute

Lisbon, 1070-064, Portugal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: September 7, 2019
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); DE (1); PT (1)