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

NCT07544849 | Completed

• 1 other identifier: Lam Nguyen Le FOS-CTUMP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Resin Infiltration; Icon; Microabrasion; Opalustre; ICDAS; Split-mouth trial; Minimally invasive dentistry; Enamel demineralization

Outcome Measures

Primary Outcomes (1)

• Reduction in lesion area ratio (R) after treatment

  The primary outcome is the change in the lesion area ratio (R), defined as the percentage of the lesion area relative to the total labial tooth surface area, measured using standardized intraoral photographs and image analysis software. Measurements will be performed at baseline and follow-up to assess the effectiveness of the interventions.

  Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)

Secondary Outcomes (1)

• Change in ICDAS score

  Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)

Study Arms (2)

Resin Infiltration (Icon)

EXPERIMENTAL

Teeth assigned to this arm will be treated using a resin infiltration technique (Icon, DMG, Germany). The procedure includes enamel conditioning with 15% hydrochloric acid (Icon Etch) for 120 seconds, followed by rinsing and drying with ethanol (Icon Dry). Resin infiltrant is then applied to the lesion surface for 3 minutes and light-cured for 40 seconds. A second application is performed for 1 minute followed by light curing. The surface is then polished to complete the procedure.

Device: Resin Infiltration

Microabrasion (Opalustre)

ACTIVE COMPARATOR

Teeth assigned to this arm will be treated using a microabrasion technique (Opalustre, Ultradent, USA). A slurry containing 6.6% hydrochloric acid and silicon carbide particles is applied to the lesion surface using a rotary instrument at approximately 500 rpm for 60 seconds per application. The surface is rinsed and the procedure may be repeated as needed. Final polishing is performed after achieving satisfactory clinical results.

Device: Microabrasion

Interventions

Resin Infiltration DEVICE

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.

Also known as: Icon (DMG, Germany)

Resin Infiltration (Icon)

Microabrasion DEVICE

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.

Also known as: Opalustre (Ultradent, USA)

Microabrasion (Opalustre)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 12 to 18 years
• Presence of at least two early caries lesions (ICDAS codes 1-2) on the labial surfaces of anterior teeth (maxillary or mandibular incisors and canines)
• Patients who are willing to participate and provide informed consent (or consent from parent/guardian for minors)

You may not qualify if:

• Teeth that have undergone endodontic treatment at the study site
• Teeth with existing restorations or requiring restorative treatment at the lesion site
• Patients with systemic conditions or oral conditions that may affect enamel integrity or interfere with treatment outcomes
• Patients who are unable to comply with follow-up visits

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho University of Medicine and Pharmacy Hospital

Can Tho, Select State, Vietnam

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Enamel Microabrasion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Esthetics, Dental; Dentistry

Study Officials

• Phuc Le, DDS

  Can Tho University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors evaluating clinical images and treatment results are blinded to the intervention allocation to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: July 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)