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A Randomized Split-Mouth Clinical Trial Comparing Resin Infiltration and Microabrasion for Early Caries Lesions

NCT07544849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-22

No results posted yet for this study

Summary

This study aims to evaluate and compare the clinical characteristics and treatment outcomes of early caries lesions using resin infiltration (Icon) and microabrasion (Opalustre). Early enamel lesions (ICDAS codes 1-2) often present as white spot lesions, which can compromise esthetics and may progress if untreated. This randomized split-mouth clinical trial will be conducted in patients presenting with at least two affected anterior teeth. Each patient will receive both interventions in different teeth, allowing direct intra-individual comparison. Outcomes will be assessed immediately after treatment and at 6 months to determine effectiveness in lesion improvement, esthetic appearance, and patient-related responses. The findings aim to provide evidence for minimally invasive management of early caries lesions.

Conditions

  • Dental Caries
  • Early Caries Lesions
  • White Spot Lesions[Initial Caries]on Smooth Surface of Tooth

Interventions

DEVICE

Resin Infiltration

A minimally invasive resin infiltration technique is applied to treat early enamel lesions. The procedure includes surface conditioning with hydrochloric acid, ethanol drying, and application of a low-viscosity resin infiltrant followed by light curing to penetrate and seal subsurface porosities.

DEVICE

Microabrasion

A microabrasion technique using a hydrochloric acid and abrasive slurry is applied to remove superficial enamel irregularities and improve the appearance of early caries lesions through controlled mechanical and chemical abrasion.

Sponsors & Collaborators

  • Can Tho University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Phuc Le, DDS · Can Tho University of Medicine and Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07544849 on ClinicalTrials.gov