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.
The purpose of this randomized, split-mouth-designed controlled and single-blinded clinical study was to evaluate the 3-year clinical performance of Class I and Class II resin composite restorations placed with or without cavity lining with a flowable composite. Fifty patients with treatment needs in two premolars or molars were included. One of the teeth was restored using the nanohybrid composite (Grandio®SO, control group), in the test group a high viscosity flowable composite was additionally applied as a first layer. In both groups, the same self-etch adhesive system was applied. Clinical evaluation after 3 years was carried out using the modified USPHS/Ryge criteria. At the 3-year follow-up the recall rate was 92%. Four restorations failed in the test group (8.7%), three due to the loss of vitality and one after fracture. The control group exhibited a cumulative success rate of 100%, while the test group achieved a success rate of 91.3%. This led to significant differences in the annual failure rate (AFR) between the two groups, with rates of 0% and 2.9% (p < 0.05; Mann–Whitney U-test). After 3 years the cumulative survival rate including all restorations was 95.7%. Statistical analysis revealed significant differences for the parameters: tooth vitality, marginal discoloration, success rate, and AFR. The other parameters exhibited no significant differences. Consequently, the nanohybrid composite demonstrated excellent performance over a 3-year period, whereas the utilization of a flowable composite for the cavity lining did not appear to exert a beneficial influence on clinical outcomes.
To assess the efficacy of Pro-Argin with respect to the oral health-related quality of life (OHRQoL) and cervical dentine hypersensitivity (CDH) in subjects with CDH for 24 weeks compared to a control group. Three study centers (one each in France, Germany, and Switzerland) included 273 subjects for 24 weeks. Patients with CDH involving at least two non-molar teeth and those with Schiff scores (cold air sensitivity scale) of 2 or 3 were included. The primary study parameter was a change in the OHRQoL from baseline to 24 weeks, as assessed by the Oral Health Impact Profile (OHIP)-49 questionnaire within and between the randomized groups. Patients were randomly assigned to the test group (TG) or the control group (CG). Prophylaxis paste and toothpaste in the TG contained 8% arginine and calcium carbonate. The toothpaste in the CG contained sodium monofluorophosphate. The level of significance was set at 5% (p = 0.05). The OHIP-49 at 24 weeks was analyzed using the analysis of covariance (ANCOVA). The mean OHIP-49 score after 24 weeks (adjusted for baseline) was significantly lower in the TG than in the CG (p = 0.005, ANCOVA). The OHIP-49 pain-related items adjusted for the baseline values also showed significant differences between the groups (p = 0.025, ANCOVA). The treatment over a period of 24 weeks using products based on the Pro-Argin technology showed a significant improvement in the OHRQoL compared to the placebo application.