Two-piece Zirconia Implants With Two Various Platforms (ZircImpl)

September 1, 2023 updated by: University of Ljubljana

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tissue-level
Two-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae.
Device: Zirconia dental implants
Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.
Experimental: Bone-level
Two-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae.
Device: Zirconia dental implants
Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crestal bone loss (mm)
Time Frame: baseline, 1-year, 3-years, 5 years
Loss of marginal bone in mm
baseline, 1-year, 3-years, 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth (mm)
Time Frame: baseline, 1-year, 3-years, 5 years
Probing pocket depth measured with periodontal probe
baseline, 1-year, 3-years, 5 years
Bleeding on probing (BOP)
Time Frame: baseline, 1-year, 3-years, 5 years
Bleeding provoked by probing
baseline, 1-year, 3-years, 5 years
Volumetric tissue change
Time Frame: 1-year, 3-years, 5 years
Sequential intraoral scanning
1-year, 3-years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ljubljana

Investigators

  • Principal Investigator: Rok Gašperšič, PhD, Faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2022

Primary Completion (Estimated)

July 3, 2024

Study Completion (Estimated)

December 3, 2024

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZIRCIMPL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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