Resin Infiltration Versus Microabrasion With CPP-ACP for Fluorotic White Spot Lesions (NCT07704983) | Clinical Trial Compass
CompletedNot Applicable
Resin Infiltration Versus Microabrasion With CPP-ACP for Fluorotic White Spot Lesions
Vietnam42 participantsStarted 2023-06-01
Plain-language summary
Dental fluorosis can cause visible chalky-white spots on the front teeth. These white spot lesions may affect dental appearance even when the tooth surface is intact.
This randomized clinical trial compared two minimally invasive approaches for masking fluorotic white spot lesions on permanent anterior teeth. Eligible teeth were randomly assigned to receive either resin infiltration or enamel microabrasion followed by application of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP).
The main outcomes were the color difference between the white spot lesion and the surrounding sound enamel and the proportion of the visible tooth surface occupied by the lesion. These outcomes were evaluated from standardized clinical photographs before treatment, after treatment, and during follow-up through 6 months.
Who can participate
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 presenting with fluorotic white spot lesions on permanent anterior teeth.
* Shallow fluorotic white spot lesions confined to the outer enamel.
* Chalky-white lesions with a clear border from adjacent sound enamel.
* Lesions appearing bright on oblique visual inspection and mildly dim under diagnostic transillumination.
* Clinical diagnosis of dental fluorosis based on the characteristic bilateral, symmetrical, and diffuse distribution of enamel opacities.
* Willingness to participate in the study and comply with treatment and follow-up visits.
Exclusion Criteria:
* Deep subsurface enamel lesions.
* Lesions consistent with molar-incisor hypomineralization.
* Lesions with yellow or brown discoloration.
* Known allergy or hypersensitivity to ICON, Opalustre, Tooth Mousse, or their components.
* Inability to tolerate rubber-dam isolation.
* Poor oral hygiene.
* Inability or unwillingness to attend the scheduled follow-up assessments.
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
CIELAB Color Difference Between the Fluorotic Lesion and Adjacent Sound Enamel
Timeframe: At baseline and four post-treatment assessments through 6 months (T0-T4)
2
Fluorotic Lesion-Area Ratio on the Labial Tooth Surface
Timeframe: At baseline and four post-treatment assessments through 6 months (T0-T4)