Two-piece Zirconia Implants With Two Various Platforms

Not Applicable

Recruiting

• Conditions: Edentulous Alveolar Ridge
• Interventions: Device: Zirconia dental implants

• Registration Number: NCT06012071
• Lead Sponsor: University of Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-03
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-07-03
• Study Completion: 2027-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone-level	Zirconia dental implants	Two-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae.
Tissue-level	Zirconia dental implants	Two-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae.

Primary Outcome Measures

Name	Time	Method
Crestal bone loss (mm)	baseline, 1-year, 3-years, 5 years	Loss of marginal bone in mm

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Centre; 🇸🇮 Ljubljana, Slovenia