Two-piece Zirconia Implants With Two Various Platforms
ConditionEdentulous Alveolar Ridge
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Ljubljana
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Single missing maxillary premolar
Occlusal stability
Good oral hygiene
Good general health
Disqualifiers
Oral mucosa pathology
Dental caries
Active periodontitis (non-treated)
Systemic diseases and conditions that affect healing or immune capacity
Trial design
Design model
Parallel
Treatments tested in this trial
Zirconia dental implants
DeviceDental implants produced from zirconia material, either wit tissue-level or bone-level platform.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Tissue-levelActive comparator 1 intervention
Group B: Bone-levelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Crestal bone loss (mm)
Loss of marginal bone in mm
Time frame
baseline, 1-year, 3-years, 5 yearsSecondary outcomes
1
Probing depth (mm)
Probing pocket depth measured with periodontal probe
Time frame
baseline, 1-year, 3-years, 5 years2
Bleeding on probing (BOP)
Bleeding provoked by probing
Time frame
baseline, 1-year, 3-years, 5 years3
Volumetric tissue change
Sequential intraoral scanning
Time frame
1-year, 3-years, 5 yearsSponsors and contacts
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Source ClinicalTrials.gov