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

Primary Purpose

Edentulous Alveolar Ridge

Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Zirconia dental implants
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring dental implants, zirconia, two-piece

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tissue-level

Bone-level

Arm Description

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

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

Outcomes

Primary Outcome Measures

Crestal bone loss (mm)
Loss of marginal bone in mm

Secondary Outcome Measures

Probing depth (mm)
Probing pocket depth measured with periodontal probe
Bleeding on probing (BOP)
Bleeding provoked by probing
Volumetric tissue change
Sequential intraoral scanning

Full Information

First Posted
August 21, 2023
Last Updated
September 1, 2023
Sponsor
University of Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT06012071
Brief Title
Two-piece Zirconia Implants With Two Various Platforms
Acronym
ZircImpl
Official Title
Comparison of Two-piece Zirconia Implants With Tissue-level and Bone-level Platform: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2022 (Actual)
Primary Completion Date
July 3, 2024 (Anticipated)
Study Completion Date
December 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
Keywords
dental implants, zirconia, two-piece

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tissue-level
Arm Type
Active Comparator
Arm Description
Two-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae.
Arm Title
Bone-level
Arm Type
Experimental
Arm Description
Two-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae.
Intervention Type
Device
Intervention Name(s)
Zirconia dental implants
Intervention Description
Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.
Primary Outcome Measure Information:
Title
Crestal bone loss (mm)
Description
Loss of marginal bone in mm
Time Frame
baseline, 1-year, 3-years, 5 years
Secondary Outcome Measure Information:
Title
Probing depth (mm)
Description
Probing pocket depth measured with periodontal probe
Time Frame
baseline, 1-year, 3-years, 5 years
Title
Bleeding on probing (BOP)
Description
Bleeding provoked by probing
Time Frame
baseline, 1-year, 3-years, 5 years
Title
Volumetric tissue change
Description
Sequential intraoral scanning
Time Frame
1-year, 3-years, 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rok Gašperšič, PhD
Phone
0038615224998
Email
rok.gaspersic@mf.uni-lj.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rok Gašperšič, PhD
Organizational Affiliation
faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rok Gašperšič, PhD
Phone
0038615224889
Email
rok.gaspersic@mf.uni-lj.si

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Two-piece Zirconia Implants With Two Various Platforms

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