Remineralization Potential of Bioactive Varnish

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07602660

Enrollment

Registered

2026-05-22

Start date

2026-06-01

Completion date

2026-12-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion

Brief summary

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

OTHERS-PRG barrier coat

varnish containing Surface pre-reacted glass-ionomer technology

OTHERProfluorid Varnish

Fluoride varnish

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 35 Years

Healthy volunteers

Inclusion criteria

1. Patients within 16-35 years of age. 2. Each patient has 4 or more WSLs 3. Mild and moderate WSLs. 4. Good oral hygiene and willing patients who can attend study visits. 5. Symmetrical number of permanent teeth in each arch (mesial to second molars).

Exclusion criteria

1. Active carious lesions. 2. Labial surface restorations. 3. Intrinsic and extrinsic stains. 4. Patients who have a significant medical history or if they are smokers. 5. Patients who participated in clinical study during the preceding six months of the start of this trial. 6. Criteria for discontinuation; Mortality and acquiring severe debilitating disease.

Design outcomes

Primary

Measure	Time frame	Description
Patients tooth caries lesion state	6 months	FDI Criteria (Visual examination of active caries lesion)

Secondary

Measure	Time frame	Description
Patients' tooth color change	6 months	VITA Easy Shade (ΔE)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026