Remineralization Potential of Bioactive Varnish Versus Sodium Fluoride Varnish in Management of White Spot Lesions: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Future University in Egypt
- Enrollment
- 60
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Mazin Mohamed Ibrahim
Master's degree Student
Future University in Egypt