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EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.

RecruitingNAAges 3 Years - 6 YearsAllYassmin Mohamed
NCT07845110 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 D

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📋 Eligibility rules (as published)
Inclusion Criteria: * • Healthy Children aged 3-6 years old. * Patients ranking definitely positive or positive on Frankel scale * The Presence of at least one active non-cavitated white spot lesion (ICDAS code 1 or 2) on the facial surface of primary teeth . * Completion of an informed consent by the guardian to participate in the study * exclusion criteria: * History of systemic disease or medication affecting enamel development * Teeth with cavitated lesions (ICDAS ≥ 3) * Previous professional fluoride treatment or laser therapy in the last 3 months
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What it tests

  • BioMin® fluoride varnish: 5% NaF varnish incorporating bioactive glass (calcium/phosphate releasing).
  • (BioMin® + Diode Laser)
  • (Duraphat varnish + Diode laser)
  • Duraphat varnish (5% sodium fluoride varnish)
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Where

2 sites
Faculty of Dentistry, Alexandria university, Egypt
Alexandria, Egypt
Faculty of Dentistry, Alexandria university, Egypt
Alexandria, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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