Two-piece Zirconia Implants With Two Various Platforms

NCT ID: NCT06012071

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-03

Study Completion Date

2027-12-03

Brief Summary

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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.

Detailed Description

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Conditions

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Edentulous Alveolar Ridge

Keywords

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dental implants zirconia two-piece

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tissue-level

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

Group Type ACTIVE_COMPARATOR

Zirconia dental implants

Intervention Type DEVICE

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

Bone-level

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

Group Type EXPERIMENTAL

Zirconia dental implants

Intervention Type DEVICE

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

Interventions

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Zirconia dental implants

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rok Gašperšič, PhD

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine

Locations

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University Medical Centre

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Rok Gašperšič, PhD

Role: CONTACT

Phone: 0038615224998

Email: [email protected]

Facility Contacts

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Rok Gašperšič, PhD

Role: primary

Other Identifiers

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ZIRCIMPL001

Identifier Type: -

Identifier Source: org_study_id