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

April 16, 2026 updated by: Can Tho University of Medicine and Pharmacy

A Randomized Split-Mouth Controlled Clinical Trial Comparing Resin Infiltration and Microabrasion for the Treatment of Early Caries Lesions in Vietnam

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early caries lesions, commonly manifested as white spot lesions, represent subsurface enamel demineralization without cavitation. These lesions are frequently observed in patients with plaque accumulation or undergoing orthodontic treatment and may progress if not managed appropriately. Minimally invasive approaches, such as resin infiltration and microabrasion, have been proposed as effective treatment strategies to arrest lesion progression and improve esthetic outcomes.

This study is designed as a randomized split-mouth controlled clinical trial to compare the effectiveness of resin infiltration (Icon, DMG, Germany) and microabrasion (Opalustre, Ultradent, USA) in the management of early caries lesions classified as ICDAS codes 1 and 2. The study will be conducted at Can Tho University of Medicine and Pharmacy Hospital.

Eligible participants will include patients aged 9 years and older presenting with at least two early caries lesions on anterior teeth. A split-mouth design will be applied, where each patient receives both interventions on different teeth, allowing intra-subject comparison and minimizing inter-individual variability.

For the resin infiltration group, the procedure includes enamel conditioning with hydrochloric acid (Icon Etch), ethanol drying (Icon Dry), and application of infiltrant resin followed by light curing. For the microabrasion group, treatment involves the application of hydrochloric acid and abrasive particles (Opalustre) using a rotary instrument under controlled conditions.

Clinical assessments will be performed at baseline (T0), immediately after treatment (T1), and at 6-month follow-up (T2). The study will evaluate changes in lesion characteristics, esthetic improvement, and patient-reported outcomes. Data will be analyzed using appropriate statistical methods to compare treatment effectiveness between the two interventions.

This study aims to provide clinical evidence on the comparative effectiveness of two minimally invasive techniques for early caries management, contributing to improved treatment decision-making in restorative and preventive dentistry.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Select State
      • Can Tho, Select State, Vietnam
        • Can Tho University of Medicine and Pharmacy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resin Infiltration (Icon)
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
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.
Other Names:
  • Icon (DMG, Germany)
Active Comparator: Microabrasion (Opalustre)
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
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.
Other Names:
  • Opalustre (Ultradent, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in lesion area ratio (R) after treatment
Time Frame: Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ICDAS score
Time Frame: Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)
Assessment of lesion severity using the International Caries Detection and Assessment System (ICDAS) at different time points to evaluate changes in lesion progression or regression.
Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Can Tho University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Phuc Le, DDS, Can Tho University of Medicine and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lam Nguyen Le FOS-CTUMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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