Remineralization Potential of Bioactive Varnish

N/ANot Yet RecruitingNCT07602660

Future University in Egypt60 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

White Spot Lesion

Interventions

S-PRG barrier coatOTHER

varnish containing Surface pre-reacted glass-ionomer technology

Profluorid VarnishOTHER

Fluoride varnish

Eligibility

Sex: ALLMin age: 16 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Patients tooth caries lesion state

FDI Criteria (Visual examination of active caries lesion)

Time frame: 6 months

Secondary Outcomes

Patients' tooth color change

VITA Easy Shade (ΔE)

Time frame: 6 months

Data from ClinicalTrials.gov

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