Clinical Outcome of Class I and II Restorations with and without an Intermediary Layer of a Flowable Composite after 24 Months: A Prospective, Randomized, Split-Mouth-Designed, Controlled and Single-Blinded Clinical Trial

Abstract

The aim of this clinical study was to evaluate the impact of an additional use of a flowable composite on the clinical success of Class I and II composite restorations. Furthermore, different clinical criteria were recorded to determine if the combination with a flowable material shows significant advantages compared to the composite material alone. In 50 patients, one cavity was solely filled with a nano-hybrid composite (control group) and the second cavity in combination with an additional layer of flowable composite (test group) using a universal adhesive system in the self-etch modus. Clinical assessments were performed according to the modified criteria proposed by USPHS/Ryge. After 24 months, 47 patients were examined resulting in a recall rate of 94%. The cumulative survival rate for all restorations after 24 months was 96.8%. Three restorations (3.2%) failed due to the loss of vitality. All failed restorations were located in the test group (6.4%), and none in the control group (0%). This resulted in a cumulative success rate in the control group of 100% and 93.6% in the test group, showing a significantly different annual failure rate (AFR) of 0% and 3.2%, respectively (p < 0.05; Mann–Whitney U-test). Beside the differences regarding the tooth vitality, success rate, and AFR, no significant influence of the flowable composite on the different evaluated clinical parameters could be detected. Therefore, the application of an additional layer of the flowable composite might have neither a positive nor a negative effect on composite restorations in clinical practice.