Dental Implants, Single-ToothNCT03908177
Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.
A study testing Ceramic Dental Implant and Titanium Dental Implant in people with Dental Implants, Single-Tooth, run by Institut Straumann AG at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Single-Tooth
- What is being tested?
- Ceramic Dental Implant and Titanium Dental Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 7 Sep 2019to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik
Düsseldorf, 40225
Hong Kong1 site
The University of Hong Kong, Prince Philip Dental Hospital
Hong Kong
About this study
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
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.
Read the 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.
- Conditions
- Dental Implants, Single-Tooth
- Being tested
- Ceramic Dental Implant, Titanium Dental Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic Dental ImplantDevice
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.
Titanium Dental ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group (SG) | Experimental | Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA Receives: Device: Ceramic Dental Implant |
| Control Group (CG) | Active comparator | Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA Receives: Device: Titanium Dental Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Level Change
Change in crestal bone level measured by analysis of standardized peri-apical xrays 12 months after loading [mm].
Measured: 12 months after implant loading (final crown restoration)
Secondary outcomes (2)
Implant survival
Implant survival rates 3, 6 months and 1 year after loading: yes/no
Measured: 12 months after loading.
14 item Oral Health Impact Profile (OHIP-14)
The local language version of the OPHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).
Measured: 12 months after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start7 Sep 2019
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implants, Single-ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908177
- Sponsor's protocol ID
- CR2017-04
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2019
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03908177
- Acronym / sponsor ID
- CR2017-04
- Conditions
- Dental Implants, Single-Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group (SG) | Experimental | Device: Ceramic Dental ImplantReceive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA |
| Control Group (CG) | Active comparator | Device: Titanium Dental ImplantReceive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceramic Dental ImplantThe 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. | Device | Study Group (SG) |
| Titanium Dental ImplantThe 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. | Device | Control Group (CG) |
Primary outcome
Bone Level Change
Time frame: 12 months after implant loading (final crown restoration)
Change in crestal bone level measured by analysis of standardized peri-apical xrays 12 months after loading [mm].
2 secondary outcomes
Implant survival
Time frame: 12 months after loading.
14 item Oral Health Impact Profile (OHIP-14)
Time frame: 12 months after loading.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceramic Dental Implant and Titanium Dental Implant in people with Dental Implants, Single-Tooth, run by Institut Straumann AG at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Hong Kong, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Level Change (time frame: 12 months after implant loading (final crown restoration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.