3-Year Clinical Performance of a New Pit and Fissure Sealant.

The aim of this 3-year, randomized clinical trial (RCT) in split-mouth design was to explore the clinical survival of a Bis-GMA-free pit and fissure sealant (Helioseal F Plus) in comparison to a control material (Helioseal F). The initial population consisted of 92 adolescents. Follow-ups took place after one year (N = 85), two years (N = 82) and three years (N = 76) after application. At each examination, sealant retention and the presence of caries were recorded. The statistical analysis included the calculation of Kaplan-Meier survival curves, log-rank tests and a Cox proportional hazard regression model. No adverse events were documented. The proportion of completely intact sealants and those with minimal loss was almost identical in both groups, at 84.3% (Helioseal F; 113/134) and 81.7% (Helioseal F Plus; 107/131) after three years of observation. The regression analysis revealed an operator dependency, but no significant differences were found between the materials, the study centers, the chosen isolation technique, patient age or sex. After 3 years, 91.7% and 100.0% of all molars were free of non-cavitated carious lesions or carious cavities, respectively. It can be concluded that the new fissure sealing material can be considered as at least equivalent in terms of survival and retention behavior compared to the predecessor material.

Clinical performance of a new fissure sealant-results from a 2-year randomized clinical trial.

OBJECTIVES: The aim of this randomized clinical trial (RCT) was to explore the clinical survival of a new, Bis-GMA-free pit and fissure sealant (Helioseal F Plus) in comparison to an established control material (Helioseal F). MATERIAL AND METHODS: This in vivo study was designed as a prospective, 2-year, two-centre RCT with a split-mouth design. The initial study population consisted of 92 adolescents who were followed up 1 month (N = 89), 6 months (N = 88), 1 year (N = 85) and 2 years (N = 82) after sealant application. The attrition rate was 10.9% after 2 years. At each examination, the sealant retention and presence of caries were recorded. The statistical analysis included the calculation of Kaplan-Meier survival curves, log-rank tests and a Cox proportional hazard regression model. RESULTS: No adverse events during the application or any of the follow-up visits were documented. The proportion of completely intact sealants and those with minimal loss was almost identical in both groups at 85.9% (Helioseal F Plus) and 86.5% Helioseal F) after 2 years of observation. The regression analysis revealed operator dependency; no significant differences were found between the materials, the study centres, the chosen isolation technique and patient age or sex. CONCLUSION: The newly developed sealant can be evaluated as at least equivalent in terms of survival and retention behaviour compared to the established control material. CLINICAL RELEVANCE: The new sealant can be recommended for clinical use. With respect to the material properties (Bis-GMA-free, less light polymerisation time and better thixotropic behaviour), it offers additional advantages with clinical relevance.

Distribution and Polarization of Caries in Adolescent Populations.

The aim of this study was to determine the proportion of adolescents with severe caries to analyze the prevalence of caries and to visualize the unequal distribution. Data from three epidemiological studies (10- and 15-year-olds: GINIplus and LISA cohorts in Munich, Bavaria; 12-year-olds: LAGZ survey in Bavaria, Germany) with 2875 adolescents were available for analysis. All individuals were examined according to the WHO standard. Statistics included the calculation of mean dmft/DMFT values (standard deviation), Significant Caries Index (SiC) values, Specific Affected Caries Index (SaC) values, and Lorenz curves. Overall caries-free status was 58.6% in primary and 83.9% in secondary teeth (10-year-olds), 61.5% (12-year-olds), and 64.6% (15-year-olds). The proportion of 12- and 15-year-olds with at least four DMFTs was 9.4% and 8.3%, respectively. In addition, eight 15-year-olds with DMFT values ≥8 (0.6%) were registered. The SaC/SiC values amounted to 1.8/0.9 DMFT (10-year-olds), 2.6/2.8 DMFT (12-year-olds), and 2.5/2.5 DMFT (15-year-olds). The mean DMFT values in the upper 1% of subjects were 4.2 DMFT (10-year-olds), 8.5 DMFT (12-year-olds), and 8.5 DMFT (15-year-olds). Thus, caries is not equally distributed throughout adolescence, but individuals with severe caries are rare. Nevertheless, further interdisciplinary research seems to be needed to clarify potential risk factors.