Edentulous Alveolar RidgeZircImplNCT06012071
Two-piece Zirconia Implants With Two Various Platforms
A study testing Zirconia dental implants in people with Edentulous Alveolar Ridge, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
24 patients with missing premolar teeth and healed sockets will be recruited. They will be randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with International Stability Quotient (ISQ) device. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Zirconia dental implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Jul 2022to 3 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single missing maxillary premolar
- Occlusal stability
- Good oral hygiene
- Good general health
Who cannot join
- Oral mucosa pathology
- Dental caries
- Active periodontitis (non-treated)
- Systemic diseases and conditions that affect healing or immune capacity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre
Ljubljana, 1000
Rok Gašperšič, PhD, 0038615224889, rok.gaspersic@mf.uni-lj.si
About this study
Official title: Comparison of Two-piece Zirconia Implants With Tissue-level and Bone-level Platform: Randomized Controlled Clinical Trial
24 patients with missing premolar teeth and healed sockets will be recruited. They will be randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with International Stability Quotient (ISQ) device. After 3 months, ceramic crowns will be supplied. Implant survival rates and parameters in relation to periimplant soft-tissues and bone health and anatomy will be recorded and evaluated after 1, 3 and 5 years.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Zirconia dental implants
- Keywords
- dental implants, zirconia, two-piece
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia dental implantsDevice
Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.
| Study group | Role | What they receive |
|---|---|---|
| Tissue-level | Active comparator | Two-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae. Receives: Device: Zirconia dental implants |
| Bone-level | Experimental | Two-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae. Receives: Device: Zirconia dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone loss (mm)
Loss of marginal bone in mm
Measured: baseline, 1-year, 3-years, 5 years
Secondary outcomes (3)
Probing depth (mm)
Probing pocket depth measured with periodontal probe
Measured: baseline, 1-year, 3-years, 5 years
Bleeding on probing (BOP)
Bleeding provoked by probing
Measured: baseline, 1-year, 3-years, 5 years
Volumetric tissue change
Sequential intraoral scanning
Measured: 1-year, 3-years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start3 Jul 2022
- Primary completion3 Jul 2026 (estimated)
- Study completion3 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rok Gašperšič, PhD, Principal investigator, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012071
- Sponsor's protocol ID
- ZIRCIMPL001
- Acronym
- ZircImpl
- Status last verified
- May 2026
- First submitted
- 21 Aug 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two-piece Zirconia Implants With Tissue-level and Bone-level Platform: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06012071
- Acronym / sponsor ID
- ZircImpl / ZIRCIMPL001
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- dental implants, zirconia, two-piece
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 3 Jul 2026 (estimated)
- Study completion
- 3 Dec 2027 (estimated)
- First posted
- 25 Aug 2023 (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.
24 patients with missing premolar teeth and healed sockets will be recruited. They will be randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with International Stability Quotient (ISQ) device. After 3 months, ceramic crowns will be supplied. Implant survival rates and parameters in relation to periimplant soft-tissues and bone health and anatomy will be recorded and evaluated after 1, 3 and 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue-level | Active comparator | Device: Zirconia dental implantsTwo-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae. |
| Bone-level | Experimental | Device: Zirconia dental implantsTwo-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single missing maxillary premolar
- Occlusal stability
- Good oral hygiene
- Good general health
Key exclusion criteria (4 listed)
- Oral mucosa pathology
- Dental caries
- Active periodontitis (non-treated)
- Systemic diseases and conditions that affect healing or immune capacity
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 |
|---|---|---|
| Zirconia dental implantsDental implants produced from zirconia material, either wit tissue-level or bone-level platform. | Device | Bone-level, Tissue-level |
Primary outcome
Crestal bone loss (mm)
Time frame: baseline, 1-year, 3-years, 5 years
Loss of marginal bone in mm
3 secondary outcomes
Probing depth (mm)
Time frame: baseline, 1-year, 3-years, 5 years
Bleeding on probing (BOP)
Time frame: baseline, 1-year, 3-years, 5 years
Volumetric tissue change
Time frame: 1-year, 3-years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Edentulous Alveolar Ridge
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Clinical and Radiographic Comparison of Two Implant-Abutment Connections
Dental Implant, Edentulous Alveolar Ridge
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Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
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Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix
Edentulous Alveolar Ridge
Recruiting
Pontic Site Development With or Without Fixed Partial Denture
Mucogingival Defects, Pontic Site Development
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
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.
Rok Gašperšič, PhD principal investigator
faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia dental implants in people with Edentulous Alveolar Ridge, run by University of Ljubljana at 1 site in Slovenia.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 May 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rok Gašperšič, PhD (0038615224998, rok.gaspersic@mf.uni-lj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone loss (mm) (time frame: baseline, 1-year, 3-years, 5 years). 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 6 May 2026.