Clinical Outcome of Fissure Sealant Control Seal After 24 Months

Objectives: The aim of the present prospective, randomized clinical trial was to investigate the retention of the new transparent fissure sealant Control Seal, in comparison to a commonly used conventional resin-based sealant (Helioseal Clear) after 24 months. Furthermore, marginal, surface texture and presence of a carious lesion were recorded.
Methods: 70 patients (140 molars) aged 6-11 years (mean age: 7,74 years, SD:±1,5 years; 47 % female) diagnosed with at least 2 sound and caries-free pits and fissures were selected for the baseline and included in the study. Where possible, both first molars were selected in the same jaw, and then randomly assigned to 1 of the 2 fissure sealants. After prophylaxis with a fluoride-free paste (Klint; Voco, Cuxhaven) and acid etching with 37 % phosphoric acid gel (Email Preparator, Ivoclar Vivadent, Schaan or Vococid, Voco), the fissure sealants Helioseal Clear (Ivoclar Vivadent) and Control Seal (Voco) were applied as recommended by the manufacturers. At follow-up, the following clinical findings were recorded: retention, marginal discoloration, marginal adaptation, air inclusions, optical surface texture, tactile surface texture, caries.
Results: After 24 months, 67 patients were followed and rated according to the study protocol. Partial loss of the material Control Seal of 1/3 was recorded in 29 teeth and of 2/3 in 4 teeth. The material Helioseal showed partial loss of 1/3 in 34 molars, loss of 2/3 in one molar as well as a complete loss of the material in one molar. Significant differences could not be detected after 24 months.
Conclusions: It can be concluded that after 24 months, no significant differences could be detected with respect to retention rates. By trend, Control Seal seams to provide more favorable results concerning surface texture. The study was supported by Voco GmbH, Cuxhaven, Germany.