Immediate Implantation of Two-piece Zirconia Dental ImplantsNCT05369299
Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement
A study testing Implant Straumann® Pure Ceramic Two Piece Implant and two-piece titanium implant Neoss® ProActive Tapered Implant in people with Immediate Implantation of Two-piece Zirconia Dental Implants, run by Medical University of Graz at 1 site in Austria.
Trial summary
The purpose of the study is to test whether a two-piece zirconia implant is as reliable in the indication of immediate implant placement as a standard titanium implant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Implantation of Two-piece Zirconia Dental Implants
- What is being tested?
- Implant Straumann® Pure Ceramic Two Piece Implant and two-piece titanium implant Neoss® ProActive Tapered Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 13 May 2022to 12 Dec 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 giving informed consent to participate in the clinical trial and fulfil the following criteria will be included in the investigation:
- good oral hygiene standard;
- good general health;
- 18 years or older;
- non-smokers;
- presence of single-tooth or multiple gaps in the mandible or the maxilla;
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- intact facial bone wall;
- sufficient bone volume to support an implant of at least 10 mm length.
- Teeth with removable periapical lesions are included.
Who cannot join
- Primary exclusion criteria are as follows:
- parafunctional habits;
- active periodontitis;
- smoking;
- pregnancy;
- acute or chronic medical conditions for which implant therapy has always been considered a contraindication: uncontrolled diabetes (HbA1c >8.0%), mucosal disease, untreated periodontitis, immunological disorders, active malignancy, alcoholism, condition after radiation therapy to the head and neck area and antiresorptive therapy.
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- Secondary exclusion criteria will be applied at surgical procedure:
- loss of facial bone wall due to extraction procedure;
- insufficient primary stability (less than 32Ncm insertion torque).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement - a Prospective Randomized Controlled Clinical Trial
The purpose of the study is to test whether a two-piece zirconia implant is as reliable in the indication of immediate implant placement as a standard titanium implant.
- Being tested
- Implant Straumann® Pure Ceramic Two Piece Implant, two-piece titanium implant Neoss® ProActive Tapered Implant
- Keywords
- zirconium oxide, Dental Implants, Prospective Studies, Osseointegration, Resonance Frequency Analysis, Patient Reported Outcome Measures, Esthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant Straumann® Pure Ceramic Two Piece ImplantDevice
Dental implants are placed directly after tooth extraction in the extraction socket.
two-piece titanium implant Neoss® ProActive Tapered ImplantDevice
Dental implants are placed directly after tooth extraction in the extraction socket.
| Study group | Role | What they receive |
|---|---|---|
| Two-piece zirconia implants | Experimental | Immediate dental implant placement will be performed by using the new two-piece zirconia implant Straumann® Pure Ceramic Two Piece Implant Receives: Device: Implant Straumann® Pure Ceramic Two Piece Implant |
| Two-piece titanium implants | Active comparator | Immediate dental implant placement will be performed by using the conventional two-piece titanium implant Neoss® ProActive Tapered Implant Receives: Device: two-piece titanium implant Neoss® ProActive Tapered Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of PTV
Periotest value, Damping capacity assessment. For Periotest values, a customizable healing abutment will be inserted to assess damping capacity.
Measured: initial, 6 and 12 months after surgical procedure
Change of ISQ
Implant stability quotient. A transducer (smart-peg sensor) will be installed on the top of the implant to measure ISQ with resonance frequency analysis. ISQ will be measured from 4 different sites (facial, lingual, mesial, distal) and calculated as mean of measurements.
Measured: initial, 6 and 12 months after surgical procedure
Secondary outcomes (20)
Change of marginal bone loss
A single radiography in paralleling technique will be performed to measure marginal bone loss in millimeters (mm). Individualized x-ray holders will be used to ensure standardization and comparability in radiographic procedure.
Measured: 6 and 12 months after surgical procedure
Change of PES
In the anterior region (4-4) the pink esthetic score (PES) (Fürhauser et al. 2005) will be used to evaluate the esthetic outcome of the soft tissue around the implant-supported single crowns by awarding seven points for the mesial and distal papilla, soft- tissue level, contour, colour, texture and alveolar process deficiency.
Measured: 6 and 12 months after surgical procedure
Change of width of keratinized mucosa
The width of keratinized mucosa will be measured in millimetres at the narrowest distance between the mucosal margin and the mucogingival junction at the buccal aspect of the implant using Lugol ́s iodine solution.
Measured: initial, 12 months after surgical procedure
Change of BOP
Bleeding on probing will be recorded as positive (BOP+) when bleeding of the peri-implant mucosa is detected at implant (tooth) site-level after probing depth assessment within periodontal status.
Measured: initial, 6 and 12 months after surgical procedure
Gingival biotype
The tissue phenotype/gingival biotype will be classified at first visit with a conventional periodontal probe. Phenotype will be classified as thin, if the outline of the underlying probe can be seen shining through the buccal mucosa and as thick phenotype, if not.
Measured: initial
Mean insertion time
Time of implant insertion in seconds (sec).
Measured: at time of surgery
Change of PROM
Patient related outcome measures. Patients ́ oral-health related quality of life will be assessed before and 12 months after implant therapy by using a 14-point standardized questionnaire (OHIP-14).
Measured: initial, 12 months after surgical procedure
Complications - biological
Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.
Measured: at time of surgical procedure, 2 weeks, 6 months and 12 months after surgical procedure
Complications - biological
Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.
Measured: at time of surgical procedure
Complications - biological
Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.
Measured: 2 weeks
Complications - biological
Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.
Measured: 6 months
Complications - biological
Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.
Measured: 12 months
Complications - technical
Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.
Measured: at time of surgical procedure
Complications - technical
Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.
Measured: 2 weeks
Complications - technical
Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.
Measured: 6 months
Complications - technical
Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.
Measured: 12 months after surgical procedure
Complications - esthetic
Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.
Measured: at time of surgical procedure
Complications - esthetic
Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.
Measured: 2 weeks
Complications - esthetic
Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.
Measured: 6 months
Complications - esthetic
Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.
Measured: 12 months after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start13 May 2022
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implantation of Two-piece Zirconia Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Model description
- prospective controlled randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Polansky, DMD, Principal investigator, Department of Dentistry and Oral Health, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369299
- Sponsor's protocol ID
- IIP Ti Zr
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement - a Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05369299
- Acronym / sponsor ID
- IIP Ti Zr
- Keywords
- zirconium oxide, Dental Implants, Prospective Studies, Osseointegration, Resonance Frequency Analysis, Patient Reported Outcome Measures, Esthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 11 May 2022 (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.
The purpose of the study is to test whether a two-piece zirconia implant is as reliable in the indication of immediate implant placement as a standard titanium implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Two-piece zirconia implants | Experimental | Device: Implant Straumann® Pure Ceramic Two Piece ImplantImmediate dental implant placement will be performed by using the new two-piece zirconia implant Straumann® Pure Ceramic Two Piece Implant |
| Two-piece titanium implants | Active comparator | Device: two-piece titanium implant Neoss® ProActive Tapered ImplantImmediate dental implant placement will be performed by using the conventional two-piece titanium implant Neoss® ProActive Tapered Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients giving informed consent to participate in the clinical trial and fulfil the following criteria will be included in the investigation:
- good oral hygiene standard;
- good general health;
- 18 years or older;
- non-smokers;
Key exclusion criteria (9 listed)
- parafunctional habits;
- active periodontitis;
- smoking;
- pregnancy;
- acute or chronic medical conditions for which implant therapy has always been considered a contraindication: uncontrolled diabetes (HbA1c >8.0%), mucosal disease, untreated periodontitis, immunological disorders, active malignancy, alcoholism, condition after radiation therapy to the head and neck area and antiresorptive therapy.
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 |
|---|---|---|
| Implant Straumann® Pure Ceramic Two Piece ImplantDental implants are placed directly after tooth extraction in the extraction socket. | Device | Two-piece zirconia implants |
| two-piece titanium implant Neoss® ProActive Tapered ImplantDental implants are placed directly after tooth extraction in the extraction socket. | Device | Two-piece titanium implants |
Primary outcome
Change of PTV
Time frame: initial, 6 and 12 months after surgical procedure
Periotest value, Damping capacity assessment. For Periotest values, a customizable healing abutment will be inserted to assess damping capacity.
Change of ISQ
Time frame: initial, 6 and 12 months after surgical procedure
Implant stability quotient. A transducer (smart-peg sensor) will be installed on the top of the implant to measure ISQ with resonance frequency analysis. ISQ will be measured from 4 different sites (facial, lingual, mesial, distal) and calculated as mean of measurements.
20 secondary outcomes
Change of marginal bone loss
Time frame: 6 and 12 months after surgical procedure
Change of PES
Time frame: 6 and 12 months after surgical procedure
Change of width of keratinized mucosa
Time frame: initial, 12 months after surgical procedure
Change of BOP
Time frame: initial, 6 and 12 months after surgical procedure
Gingival biotype
Time frame: initial
Mean insertion time
Time frame: at time of surgery
Change of PROM
Time frame: initial, 12 months after surgical procedure
Complications - biological
Time frame: at time of surgical procedure, 2 weeks, 6 months and 12 months after surgical procedure
Complications - biological
Time frame: at time of surgical procedure
Complications - biological
Time frame: 2 weeks
Complications - biological
Time frame: 6 months
Complications - biological
Time frame: 12 months
Complications - technical
Time frame: at time of surgical procedure
Complications - technical
Time frame: 2 weeks
Complications - technical
Time frame: 6 months
Complications - technical
Time frame: 12 months after surgical procedure
Complications - esthetic
Time frame: at time of surgical procedure
Complications - esthetic
Time frame: 2 weeks
Complications - esthetic
Time frame: 6 months
Complications - esthetic
Time frame: 12 months after surgical procedure
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 16 Jan 2026.
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.
Raoul Polansky, DMD principal investigator
Department of Dentistry and Oral Health, Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant Straumann® Pure Ceramic Two Piece Implant and two-piece titanium implant Neoss® ProActive Tapered Implant in people with Immediate Implantation of Two-piece Zirconia Dental Implants, run by Medical University of Graz at 1 site in Austria.
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 9 inclusion and 9 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Change of PTV (time frame: initial, 6 and 12 months after surgical procedure). The study lists 2 primary outcomes in all. 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 16 Jan 2026.