Biomin fluoride varnish vs. Duraphat, with or without diode laser, for white spot lesions in primary teeth
Official title: EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH (A RANDOMIZED CONTROLLED CLINICAL TRIAL)
Run by Alexandria University · NCT07845110 · Data updated 2026-11-12
This trial tests whether Biomin fluoride varnish, alone or with diode laser, can better remineralize white spot lesions in young children than standard Duraphat varnish.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 6 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 2 sites (Alexandria, Alexandria Governorate and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07845110 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy children aged 3-6 years with at least one active non-cavitated white spot lesion on a facial surface of a primary tooth (ICDAS 1–2).
✕Probably not a fit
Children without active white spot lesions or with cavitated lesions (ICDAS ≥3) may not benefit from this remineralization approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized study, preschool children with active non-cavitated white spot lesions on primary anterior teeth receive one of four treatments: BioMin fluoride varnish, BioMin varnish plus diode laser, Duraphat varnish with diode laser, or Duraphat varnish alone. The aim is to compare remineralization over six months across these groups. The trial leverages a parallel-group design with 80 lesions allocated to the four arms and is conducted at the Faculty of Dentistry, Alexandria University. Outcomes focus on changes in the white spot lesions and surface integrity, using ICDAS criteria for lesion status. The study explores whether the bioactive glass in BioMin can enhance fluoride uptake and whether diode laser irradiation provides an additive benefit.
Why it matters
Potential benefit: If successful, children could experience faster or deeper remineralization of early lesions, potentially reducing the risk of cavitation.
How similar studies have gone: Previous research on BioMin fluoride and diode laser with fluoride shows mixed results; this trial seeks to clarify effectiveness in primary teeth.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Faculty of Dentistry, Alexandria university, Egypt
Alexandria, Alexandria Governorate, Egypt Recruiting -
Faculty of Dentistry, Alexandria university, Egypt
Alexandria, Alexandria Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Yassmin Mohamed Hassan, BDs
- Email: yassmin.moh150@gmail.com
- Phone: +20 01005364640
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.