Remineralization Potential of Bioactive Varnish
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: S-PRG barrier coat, Profluorid Varnish.
- Who it may be relevant to
- Registry conditions: White Spot Lesion. Basic parameters: 16 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remineralization Potential of Bioactive Varnish Versus Sodium Fluoride Varnish in Management of White Spot Lesions: Randomized Controlled Trial
Overview
This randomized controlled trial is held to investigate the effectiveness of two remineralizing agents surface pre-reacted glass-ionomer (S-PRG) filler and fluoride in management of white spot lesions.
Detailed description
Surface pre-reacted glass-ionomer (S-PRG) technology represents a newer bioactive approach that extends beyond the effects of fluoride alone. S-PRG fillers release multiple ions, including fluoride, strontium, sodium, silicate, borate, and aluminum, which act synergistically to promote remineralization, buffer acidic conditions, and inhibit bacterial activity In vitro and clinical evidence indicates that S-PRG-containing materials promote enamel remineralization and lesion stabilization, as laboratory studies have shown enhanced subsurface lesion repair, reduced lesion depth, and improved enamel surface morphology compared with controls, while clinical applications of PRG Barrier Coat have demonstrated significant reductions in white spot lesion area and increased enamel hardness for up to one year
Interventions
- Other S-PRG barrier coat
varnish containing Surface pre-reacted glass-ionomer technology - Other Profluorid Varnish
Fluoride varnish
Primary outcome measures
- Patients tooth caries lesion state [Time frame: 6 months]
Secondary outcome measures (1)
- Patients' tooth color change [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patients within 16-35 years of age.
- Each patient has 4 or more WSLs
- Mild and moderate WSLs.
- Good oral hygiene and willing patients who can attend study visits.
- Symmetrical number of permanent teeth in each arch (mesial to second molars).
Exclusion criteria
- Active carious lesions.
- Labial surface restorations.
- Intrinsic and extrinsic stains.
- Patients who have a significant medical history or if they are smokers.
- Patients who participated in clinical study during the preceding six months of the start of this trial.
- Criteria for discontinuation; Mortality and acquiring severe debilitating disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07602660 · 5-2026