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Recruiting

NCT Number: NCT06012071

Two-piece Zirconia Implants With Two Various Platforms

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.

Recruiting

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Key information

Conditions

Edentulous Alveolar Ridge

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Rok Gašperšič, PhD

CONTACT

[email protected]

0038615224889

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zirconia dental implants

Device

Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.

Primary outcomes

  1. Crestal bone loss (mm)

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

    Loss of marginal bone in mm

Secondary outcomes

  1. Probing depth (mm)

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

    Probing pocket depth measured with periodontal probe

  2. Bleeding on probing (BOP)

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

    Bleeding provoked by probing

  3. Volumetric tissue change

    Time frame: 1-year, 3-years, 5 years

    Sequential intraoral scanning

Study contacts

Contact information is provided by the study sponsor or research team.

Rok Gašperšič, PhD

CONTACT

[email protected]

0038615224998

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Registry information

Official study title

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

Acronym: ZircImpl

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 25, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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