15-year results of a randomized split-mouth clinical trial of ceramic partial crowns cemented with self-adhesive luting cement with or without selective enamel etching

Phase 4

• Conditions: K02.9; Dental caries, unspecified

• Registration Number: DRKS00032759
• Lead Sponsor: Poliklinik für Zahnerhaltung und Parodontologie, Universitätsklinikum Regensburg

Brief Summary

After 15 years, 19 patients were available for clinical evaluation (recall rate: 56%). Kaplan-Meier analysis showed a cumulative survival of 78.1% for RXU+E and of 42.9% for RXU-E, indicating a significantly higher survival rate for RXU+E. Regarding clinical performance of PCC available for the 15-year evaluation, no statistically significant differences were observed between RXU+E and RXU-E using the modified USPHS and FDI criteria. Both groups showed significant deterioration in surface gloss, edge matching, and edge discoloration over time. RXU+E resulted in significantly worse anatomic shape over time and significant improvement in postoperative hypersensitivity compared with baseline.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-07-17
• Results First Posted: 2023-07-19
• Study Start: 2023-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

The patients were recruited from the patient pool of the Department of Operative Dentistry and Periodontology of the University of Regensburg. They were included in the study if

They were suffering from at least two large defects of the dental hard tissues suitable for the restoration with partial ceramic crowns. No initial carious lesions were treated. All defects were formerly insufficient amalgam or composite restorations.

The teeth to be restored did not reveal any symptoms of pain.

The application of rubber dam for the insertion of the restorations was possible.

Tooth mobility was lower than or equal to degree 1 (mobility of the tooth is discernible but not visible)

Additionally, all patients participating in the study exhibited a moderate level of oral hygiene represented by a papillary bleeding index (PBI) <35%

All patients were generally healthy and had no known allergies to the materials used.

Exclusion Criteria

All issues contradicting the additional inclusion criteria.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kaplan Meier Survival

Secondary Outcome Measures

Name	Time	Method
Clinical success evaluated with FDI and modified USPHS criteria