Actively Recruiting

Phase Not Applicable
Age: 25Years +
All Genders
Healthy Volunteers
ID06012071

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

Led by University of Ljubljana · Updated on 2026-05-06

24

Participants Needed

1

Research Sites

74 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating two types of two-piece zirconia dental implants in adults with missing premolar teeth in the upper jaw. The study focuses on comparing implants with tissue-level platforms versus bone-level platforms. The goal is to assess implant stability, survival rates, and their effects on surrounding bone and soft tissue health over several years. The trial is randomized and triple-blinded to ensure reliable results. Participants will be randomly assigned to receive either a 10-mm long, 4-mm wide zirconia implant with a tissue-level platform or a similar implant with a bone-level platform. After implant placement, stability will be measured using the International Stability Quotient device. Three months after the implant, ceramic crowns will be placed. The study will continue to monitor the implants and surrounding tissues at 1, 3, and 5 years after placement. During the study, participants will undergo evaluations including measurements of crestal bone loss, probing depth, bleeding on probing, and volumetric tissue changes at baseline and during follow-ups at 1, 3, and 5 years. The researchers will track implant survival and health of the peri-implant tissues over time. Participants will be followed for a total of 5 years to provide long-term data on implant performance and tissue response.

CONDITIONS

Brief Title

Two-piece Zirconia Implants With Two Various Platforms

Who Can Participate

Age: 25Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Single missing maxillary premolar
  • Occlusal stability
  • Good oral hygiene
  • Good general health
  • Age 25 years or older
Not Eligible

You will not qualify if you...

  • Oral mucosa pathology
  • Dental caries
  • Active untreated periodontitis
  • Systemic diseases or conditions affecting healing or immune capacity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Single procedure with ongoing observation

Participants receive two-piece zirconia dental implants either with tissue-level or bone-level platforms in the single gap premolar region of the maxillae.

1 implant procedure visit and follow-up visits as part of routine dental care

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for crestal bone loss, probing depth, bleeding on probing, and volumetric tissue changes after implant placement.

Visits at baseline, 1 year, 3 years, and 5 years

Trial Site Locations

Total: 1 location

1

University Medical Centre

Ljubljana, Slovenia, 1000

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Research Team

R

Rok Gašperšič, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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