Two-piece Zirconia Implants With Two Various Platforms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zirconia dental implants.
- Who it may be relevant to
- Registry conditions: Edentulous Alveolar Ridge. Basic parameters: from 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Two-piece Zirconia Implants With Tissue-level and Bone-level Platform: Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Device Zirconia dental implants
Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.
Primary outcome measures
- Crestal bone loss (mm) [Time frame: baseline, 1-year, 3-years, 5 years]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Single missing maxillary premolar
- Occlusal stability
- Good oral hygiene
- Good general health
Exclusion criteria
- Oral mucosa pathology
- Dental caries
- Active periodontitis (non-treated)
- Systemic diseases and conditions that affect healing or immune capacity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University Medical Centre — Ljubljana
Identifiers
NCT: NCT06012071 · ZIRCIMPL001