Remineralization Potential of Bioactive Varnish

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: White Spot Lesion
• Intervention / Treatment: Other: S-PRG barrier coat; Other: Profluorid Varnish

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-PRG barrier coat; varnish containing Surface pre-reacted glass-ionomer technology	Other: S-PRG barrier coat; varnish containing Surface pre-reacted glass-ionomer technology
Active Comparator: Profluorid Varnish; Fluoride varnish	Other: Profluorid Varnish; Fluoride varnish

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 16, 2026
• First Submitted That Met QC Criteria: May 16, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 5-2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No