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Three-Year Practice-Based Clinical Trial on the Performance of a Self-Adhesive Resin-Based Bulk-Fill Restorative
Andreas Rathke1,2, Frank Pfefferkorn1, Michael Kent McGuire3
1Clinical Research, Dentsply Sirona, Konstanz, Germany.
Summary
This study evaluated self-adhesive resin-based bulk-fill restorations over three years. The novel material demonstrated acceptable clinical performance in various cavity classes, confirming its suitability for daily dental practice.
Area of Science:
- Dentistry
- Dental Materials Science
- Restorative Dentistry
Background:
- Self-adhesive resin-based materials offer simplified placement in dental restorations.
- Bulk-fill composites aim to improve efficiency in restoring cavities.
- Long-term clinical data on novel self-adhesive bulk-fill materials are crucial for evidence-based practice.
Purpose of the Study:
- To prospectively evaluate the clinical performance of a self-adhesive, dual-curing composite hybrid (Surefil one) in bulk-fill restorations.
- To assess the longevity and clinical acceptability of this novel restorative material over a 3-year period.
- To determine the annual failure rate of these restorations in various cavity classes.
Main Methods:
- A prospective clinical study involving 7 general dental practitioners.
- 60 cavities (Class I, II, V) in 41 subjects were restored with the self-adhesive bulk-fill composite.
- Restorations were evaluated annually using modified USPHS criteria for 3 years, with failure defined as replacement or repair.
Main Results:
- After 3 years, 29 recalled teeth remained vital with no hypersensitivity.
- Three restorations failed (annual failure rate of 3.94%), one due to cracking, two due to marginal gap/chipping.
- Remaining restorations were clinically acceptable, with Class II restorations maintaining proximal contact and two showing color mismatch.
Conclusions:
- The self-adhesive composite hybrid demonstrated acceptable clinical outcomes up to 3 years in load-bearing (Class I, II) and non-retentive (Class V) cavities.
- Three-year data support the suitability of this novel self-adhesive restorative material for stress-bearing posterior restorations.
- The material's performance in daily routine placement indicates its potential for widespread clinical adoption.

