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NCT06012071 Clinical Trial

Two-piece Zirconia Implants With Two Various Platforms

Edentulous Alveolar Ridge Clinical Trial

— ZircImpl  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06012071
Other study ID # ZIRCIMPL001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 3, 2022
Est. completion date December 3, 2024

Study information
Verified date August 2023
Source University of Ljubljana
Contact Rok Gašperšic, PhD
Phone 0038615224998
Email rok.gaspersic@mf.uni-lj.si
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date December 3, 2024
Est. primary completion date July 3, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zirconia dental implants
Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.

Locations
Country Name City State
Slovenia University Medical Centre Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Crestal bone loss (mm) Loss of marginal bone in mm baseline, 1-year, 3-years, 5 years
Secondary Probing depth (mm) Probing pocket depth measured with periodontal probe baseline, 1-year, 3-years, 5 years
Secondary Bleeding on probing (BOP) Bleeding provoked by probing baseline, 1-year, 3-years, 5 years
Secondary Volumetric tissue change Sequential intraoral scanning 1-year, 3-years, 5 years
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