الفهرس 
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Abstract
Aim: The aim of this study is to determine the Clinical and Cost-effectiveness of Fluoride Varnish versus Resin based fissure Sealant in Newly Erupted Permanent Molars in a group of Egyptian Children.
Study design: Randomized Clinical Trial (RCT): allocation-blinded, two-arm, parallel-group trial. As the fissure sealant is apparent to the patient, parent, operator, and outcome assessor, no one is blinded; only the statisticians could be blinded. The total number of participants was calculated as 182 participants teeth & was divided into 2 equal groups treated by 2 post-graduate students; this part included 91 participants, ages ranging from 6 to 8 years. The participants were divided into 2 groups to receive one of the tested materials: Fissure sealant (FS) as a control and biannual application of Fluoride varnish (FV) as an intervention. To provide good oral hygiene and preserve the result of the preventive measures, written oral hygiene measures and dietary instructions were given to the children and their parents. Follow-up visits were at 6 and 12 months. Outcomes were clinical effectiveness measured with DFS score, cost-effectiveness measured using incremental cost-effectiveness ratio (ICER). Secondary outcomes measured were acceptability by the child and the parents and adverse effects using a custom-made questionnaire, and the time of application was calculated using the stopwatch.
Results: At this part of the RCT study 91 teeth were randomly allocated to both tested groups. There were 28 (56.0%) males and 18 (43.9%) females in the FV group, while in the FS group there were 22 (44.0%) males and 23(56.1%) females. The mean age in the FV was (7.00±1.12) years, while in FS it was (7.29±1.42) years. There was no significant difference between both groups regarding demographic data (p>0.05). There was a strong agreement between both examiners (weighted kappa=0.815). The result showed that FV was not statistically inferior to FS in clinical effectiveness (p>0.05), and the effect size was small (r<0.3). According to the cost-effectiveness, FS had higher average cost-effectiveness ratio, and the incremental cost effectiveness ratio after 6 months was 12.463, and after 12 months was 13.901. The time of application at baseline results showed that FV has a significantly lower application time than FS (p<0.001), and the effect size was large. While after 6 and 12 months, the difference was not statistically significant (p>0.05) and the effect size was moderate. The acceptability showed that the odds of treatment unacceptability in FV was not statistically inferior to FS. There were no adverse effects in both groups.
Conclusion: Based on the 12 months results the 2 preventive methods are recommended to be used in prevention of dental caries. Furthermore, FV was not statistically inferior to FS. The FS had higher average cost-effectiveness ratio than FV. The 2 preventive methods are acceptable and no adverse effect was detected. The FV applications were found to take less time than FS.
Keywords: Fluoride varnish, cost-effectiveness, fissure sealant, acceptability, adverse effect.