A Randomized Split-Mouth Clinical Trial Comparing Resin Infiltration and Microabrasion for Early … (NCT07544849) | Clinical Trial Compass
CompletedNot Applicable
A Randomized Split-Mouth Clinical Trial Comparing Resin Infiltration and Microabrasion for Early Caries Lesions
Vietnam30 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in lesion area ratio (R) after treatment
Timeframe: Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)
Trial details
NCT IDNCT07544849
SponsorCan Tho University of Medicine and Pharmacy