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Clinical Trials/NCT06012071
NCT06012071
Recruiting
Not Applicable

Comparison of Two-piece Zirconia Implants With Tissue-level and Bone-level Platform: Randomized Controlled Clinical Trial

University of Ljubljana1 site in 1 country24 target enrollmentJuly 3, 2022
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ConditionsEdentulous Alveolar Ridge

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edentulous Alveolar Ridge
Sponsor
University of Ljubljana
Enrollment
24
Locations
1
Primary Endpoint
Crestal bone loss (mm)
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
July 3, 2022
End Date
December 3, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Crestal bone loss (mm)

Time Frame: baseline, 1-year, 3-years, 5 years

Loss of marginal bone in mm

Secondary Outcomes

  • Volumetric tissue change(1-year, 3-years, 5 years)
  • Probing depth (mm)(baseline, 1-year, 3-years, 5 years)
  • Bleeding on probing (BOP)(baseline, 1-year, 3-years, 5 years)

Study Sites (1)

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