NCT06012071

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jul 2022Dec 2027

Study Start

First participant enrolled

July 3, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

August 21, 2023

Last Update Submit

May 5, 2026

Conditions

Edentulous Alveolar Ridge

Keywords

dental implantszirconiatwo-piece

Outcome Measures

Primary Outcomes (1)

  • Crestal bone loss (mm)

    Loss of marginal bone in mm

    baseline, 1-year, 3-years, 5 years

Secondary Outcomes (3)

  • Probing depth (mm)

    baseline, 1-year, 3-years, 5 years

  • Bleeding on probing (BOP)

    baseline, 1-year, 3-years, 5 years

  • Volumetric tissue change

    1-year, 3-years, 5 years

Study Arms (2)

Tissue-level

ACTIVE COMPARATOR

Two-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae.

Device: Zirconia dental implants

Bone-level

EXPERIMENTAL

Two-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae.

Device: Zirconia dental implants

Interventions

Zirconia dental implantsDEVICE

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

Bone-levelTissue-level

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single missing maxillary premolar
  • Occlusal stability
  • Good oral hygiene
  • Good general health

You may not qualify if:

  • Oral mucosa pathology
  • Dental caries
  • Active periodontitis (non-treated)
  • Systemic diseases and conditions that affect healing or immune capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre

Ljubljana, 1000, Slovenia

RECRUITING

Study Officials

  • Rok Gašperšič, PhD

    faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rok Gašperšič, PhD

CONTACT

0038615224998rok.gaspersic@mf.uni-lj.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

July 3, 2022

Primary Completion (Estimated)

July 3, 2026

Study Completion (Estimated)

December 3, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)