Dental CariesICON-CTUNCT07544849
A Randomized Split-Mouth Clinical Trial Comparing Resin Infiltration and Microabrasion for Early Caries Lesions
A study testing Resin Infiltration and Microabrasion in people with Dental Caries and Early Caries Lesions, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Dental Caries, Early Caries Lesions, White Spot Lesions[Initial Caries]on Smooth Surface of Tooth
- What is being tested?
- Resin Infiltration and Microabrasion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Can Tho University of Medicine and Pharmacy Hospital
Can Tho, Select State
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries, Early Caries Lesions, White Spot Lesions[Initial Caries]on Smooth Surface of Tooth
- Being tested
- Resin Infiltration, Microabrasion
- Keywords
- Resin Infiltration, Icon, Microabrasion, Opalustre, ICDAS, Split-mouth trial, Minimally invasive dentistry, Enamel demineralization
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin InfiltrationDevice
Also called Icon (DMG, Germany)
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.
MicroabrasionDevice
Also called Opalustre (Ultradent, USA)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Microabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)
Secondary outcomes (1)
Change in ICDAS score
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.
Measured: Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jul 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuc Le, DDS, Principal investigator, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544849
- Sponsor's protocol ID
- Lam Nguyen Le FOS-CTUMP
- Acronym
- ICON-CTU
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Split-Mouth Controlled Clinical Trial Comparing Resin Infiltration and Microabrasion for the Treatment of Early Caries Lesions in Vietnam
- ClinicalTrials.gov ID
- NCT07544849
- Acronym / sponsor ID
- ICON-CTU / Lam Nguyen Le FOS-CTUMP
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin Infiltration (Icon) | Experimental | Device: Resin InfiltrationTeeth 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. |
| Microabrasion (Opalustre) | Active comparator | Device: MicroabrasionTeeth 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resin InfiltrationAlso: Icon (DMG, Germany)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 | Resin Infiltration (Icon) |
| MicroabrasionAlso: Opalustre (Ultradent, USA)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. | Device | Microabrasion (Opalustre) |
Primary outcome
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.
1 secondary outcome
Change in ICDAS score
Time frame: Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phuc Le, DDS principal investigator
Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin Infiltration and Microabrasion in people with Dental Caries and Early Caries Lesions, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in lesion area ratio (R) after treatment (time frame: Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.