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

Abstract

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.

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

“…The original split-mouth-designed in vivo study was envisioned as a prospective, two-center RCT to compare the test sealant (Helioseal F Plus, Ivoclar Vivadent AG, Schaan, Liechtenstein) with the control material (Helioseal F, Ivoclar Vivadent AG, Schaan, Liechtenstein) [13]. The clinical trial as well as the extension received ethical approval from the corresponding ethical boards (Ludwig-Maximilians-University of Munich: Project number 18-319; Cantonal Ethics Committee in Zurich: Basec-Number 2018-00707).…”

“…The Department of Conservative Dentistry and Periodontology of the LMU Munich, Germany, and a dental practice in Wädenswil, Switzerland, managed the clinical treatments and observations between September 2018 and March 2022. The ethical standards of the institutional research board, the modified Helsinki Declaration and the CONSORT guidelines served as the foundation for the implementation of the RCT [13][14][15][16].…”

“…[17], beforehand. Here, an alpha of 5%, a confidence interval of 95% and an effect size of 0.60 with two groups, each with at least 40 individuals, yielded a power of 0.80 [13]. The study population was recruited from the patient pool in each study center.…”

“…Known allergies or intolerances to methacrylates or other substances of fissure sealants or any other restorative filling materials were considered exclusion criteria [20,21]. To be included, at least one fully or partially unsealed pair of permanent first or second inferior or superior molars had to show an ICDAS score <3 [22] and no hypomineralization or aberrations [13]. If the inclusion criteria were fulfilled and both the (fully informed) patients and their guardians had agreed to participate in the study after extensive information, the fissure sealants were placed by one of the responsible dentists (LMU: JK; HS Wädenswil: PG) in a separate appointment.…”

“…A Bis-GMA-free fissure sealant, Helioseal F Plus (Ivoclar Vivadent AG, Schaan, Liechtenstein), was introduced to the dental market recently. A two-year randomized clinical trial (RCT) showed that Helioseal F Plus (Ivoclar Vivadent AG, Schaan, Liechtenstein) exhibited similar clinical performance to its predecessor product, Helioseal F (Ivoclar Vivadent AG, Schaan, Liechtenstein), and could therefore be recommended for clinical use [13]. To provide more long-term clinical data, the existing two-year RCT was extended by another year.…”