Clinical performance of posterior 3-unit zirconia Fixed Partial Dentures

Phase 4

• Conditions: K02.9; Dental caries, unspecified

• Registration Number: DRKS00022182
• Lead Sponsor: 3M Oral Care

Brief Summary

Despite the current pandemic situation, all planned patients could be enrolled into the study and baseline evaluations could be carried out. No dropouts were reported. Overall, 22 patients were enrolled in the study and passed the BASELINE-evaluation. For baseline all FDI criteria were clinically acceptable. Periodontal probing depth was considered as clinically normal. 21 patients could be examined in the course of the 1 year, 2 year and 3 year follow-ups. One patient did not show up each. Survival was 100%. Two non-serious AE were reported before the 2 year and one before the 3 year follow-up respectively. All FDI criteria were rated clinically acceptable. Changes to the parameters, e.g., in terms of marginal fit, could be explained to some extent by small individual variations in measurement by the evaluators. Periodontal probing depth was considered physiological. The patients’ general rating of the treatment, which was conducted after the 1 year follow-up was “very good”.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-16
• Study Completion: 2023-05-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1.Subjects in need of posterior three-unit bridge
2.Age 18-99
3.Subjects with healthy / treated periodontal status (max. degree of movement 1)
4.Subject agrees to participate in the study and signs informed consent

Exclusion Criteria

1.Subject has known allergies to any product used during this study
2.Subject won´t be available for a study duration of 3 years
3.Untreated periodontitis
4.Patient participates in another dental clinical study
5. Pregnant and / or lactating women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate of restoration during the three- year study duration evaluated according to FDI criteria

Secondary Outcome Measures

Name	Time	Method
Quality of restorations during the three-year observation period evaluated according to FDI criteria