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NCT Number: NCT07602660

Remineralization Potential of Bioactive Varnish

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.

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Key information

Conditions

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-PRG Barrier coat

Other

varnish containing Surface pre-reacted glass-ionomer technology

Profluorid Varnish

Other

Fluoride varnish

Primary outcomes

  1. Patients tooth caries lesion state

    Time frame: 6 months

    FDI Criteria (Visual examination of active caries lesion)

Secondary outcomes

  1. Patients' tooth color change

    Time frame: 6 months

    VITA Easy Shade (ΔE)

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Remineralization Potential of Bioactive Varnish Versus Sodium Fluoride Varnish in Management of White Spot Lesions: Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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