Clinical trials

The goal of this randomized controlled clinical trial is to assess and compare the remineralizing effect of Biomin fluoride varnish and conventional 5% sodium fluoride varnish (Duraphat), with and without adjunctive low-level diode laser irradiation, in preschool children with active white spot lesions in primary anterior teeth. The study will include healthy children aged 3-6 years with at least one active, non-cavitated white spot lesion (ICDAS-II score 1 or 2). The study will be conducted at the Faculty of Dentistry, Alexandria University, with a total of 80 lesions randomly allocated to four parallel groups. The main questions it aims to answer are: Does Biomin fluoride varnish produce a different remineralizing effect compared with conventional 5% sodium fluoride varnish (Duraphat) after 6 months? Does adding 980-nm low-level diode laser irradiation to Biomin fluoride varnish or Duraphat improve the remineralization of white spot lesions compared with the corresponding varnish alone? Do the different treatments result in changes in lesion severity and activity, as assessed by ICDAS-II and DIAGNOdent readings? Do the treatments reduce the surface area of white spot lesions after 6 months? Researchers will compare four treatment groups to assess differences in remineralization: Group I (n=20): Biomin fluoride varnish (5% sodium fluoride incorporating bioactive glass). Group II (n=20): Biomin fluoride varnish combined with low-level diode laser. Group III (n=20): Duraphat 5% sodium fluoride varnish combined with low-level diode laser. Group IV (n=20): Duraphat 5% sodium fluoride varnish alone (control group). Participants will: Undergo baseline assessment of their white spot lesions using ICDAS-II visual-tactile examination, DIAGNOdent laser fluorescence, and standardized photographic assessment. Receive the randomly assigned fluoride varnish treatment, with diode laser irradiation applied to Groups II and III using a 980-nm diode laser. Return for follow-up assessments at 1, 3, and 6 months. At 3 months, the assigned varnish and laser treatment will be reapplied according to the group. Have lesion severity and activity assessed using ICDAS-II and changes in mineralization assessed through DIAGNOdent readings. At 6 months, standardized photographs will also be used to evaluate changes in lesion surface area. Follow post-treatment instructions, including avoiding fluoride-containing products on the day of varnish application and avoiding eating and drinking for at least 4 hours. The primary outcome is caries arrest/remineralization assessed through changes in lesion severity and activity using ICDAS-II and changes in mean DIAGNOdent readings at 1, 3, and 6 months. The secondary outcome is the change in white spot lesion surface area measured by standardized photographic assessment at 6 months.