An interventional study of Resin infiltration and Enamel Microabrasion Plus CPP-ACP in Dental Fluorosis, sponsored by Hue University of Medicine and Pharmacy. Completed at 1 site in Vietnam. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Hue University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
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.
This was a prospective, controlled, two-arm randomized clinical trial conducted at the Dental Clinic of the University of Medicine and Pharmacy Hospital, Hue University, Vietnam, between June 2023 and June 2025. Patients with fluorotic white spot lesions on permanent anterior teeth were enrolled. Eligible lesions were shallow, chalky-white enamel opacities confined to the outer enamel and clinically consistent with dental fluorosis.
Randomization was performed at the tooth level. A total of 60 eligible teeth were allocated in a 1:1 ratio to one of two treatment groups: resin infiltration or enamel microabrasion followed by CPP-ACP application. Allocation was concealed using sequentially numbered, opaque, sealed envelopes. All procedures were performed by one operator under standardized clinical conditions.
In the resin-infiltration group, the lesion surface was treated with 15% hydrochloric acid, rinsed and dried, followed by ethanol application. A low-viscosity resin infiltrant was then applied and light-cured according to the study protocol.
In the microabrasion plus CPP-ACP group, the labial enamel surface was treated with a hydrochloric-acid and silicon-carbide microabrasion material using repeated polishing cycles. CPP-ACP paste was then applied to the treated surface for 5 minutes.
Two co-primary outcomes were evaluated from standardized clinical photographs: the color difference between the lesion and adjacent sound enamel, expressed as ΔE in the CIELab* color space, and the lesion-area ratio, expressed as the percentage of the visible labial tooth surface occupied by the lesion. Images were obtained under reproducible lighting, magnification, camera-positioning, and patient-positioning conditions.
Color measurements were obtained from sampled points within the lesion and adjacent sound enamel. Lesion area and total labial-surface area were outlined and measured using image-analysis software. Outcome assessments were performed by an independent examiner who was blinded to treatment allocation using coded image files. Measurements were obtained before treatment and at prespecified post-treatment and follow-up assessments through 6 months.
22 studies on the registry are indexed under Fluorosis, Dental; 4 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 18 interventional studies indexed under Fluorosis, Dental.
Browse Fluorosis, Dental studies →Hue University of Medicine and Pharmacy is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible fluorotic white spot lesions were treated with resin infiltration using the ICON Vestibular Kit. After rubber-dam isolation, 15% hydrochloric acid was applied for 120 seconds, rinsed for 30 seconds, and air-dried. Ethanol was applied for 30 seconds, and the etching step was repeated if needed. The resin infiltrant was then applied, excess material was removed, and the surface was light-cured according to the study protocol.
Procedure: Resin infiltration
Eligible fluorotic white spot lesions were treated with enamel microabrasion followed by CPP-ACP application. Opalustre containing 6.6% hydrochloric acid and silicon carbide particles was applied to the labial enamel surface and polished with a rubber cup at approximately 500 rpm for 60 seconds. The procedure was repeated for five cycles, followed by application of CPP-ACP gel for 5 minutes.
Procedure: Enamel Microabrasion Plus CPP-ACP
After tooth cleaning and rubber-dam isolation, 15% hydrochloric acid was applied to the fluorotic white spot lesion for 120 seconds, rinsed for 30 seconds, and air-dried. Ethanol was applied for 30 seconds to assess lesion masking, and the etching step was repeated if the lesion remained visible. A low-viscosity resin infiltrant was applied for 180 seconds, excess material was removed, and the surface was light-cured for 40 seconds. A second application was performed for 60 seconds and light-cured for an additional 40 seconds.
After tooth cleaning and rubber-dam isolation, an enamel microabrasion material containing 6.6% hydrochloric acid and silicon carbide particles was applied to the labial enamel surface and polished with a rubber cup at approximately 500 rpm for 60 seconds. The surface was rinsed, and the procedure was repeated for five cycles. CPP-ACP paste was then applied to the treated enamel surface for 5 minutes.
CIELAB Color Difference Between the Fluorotic Lesion and Adjacent Sound Enamel
The color difference between the fluorotic white spot lesion and adjacent sound enamel was measured from standardized clinical photographs in the CIELab\* color space. Mean L\*, a\*, and b\* values were obtained from three points within the lesion and three points on adjacent sound enamel located 2 mm from the lesion margin. Color difference was calculated as ΔE = \[(ΔL\*)² + (Δa\*)² + (Δb\*)²\]¹ᐟ². Lower ΔE values indicate better color matching and lesion masking. A ΔE value below 3.7 was considered not clinically perceptible to the naked eye.
Time frame: At baseline and four post-treatment assessments through 6 months (T0-T4)
Fluorotic Lesion-Area Ratio on the Labial Tooth Surface
The fluorotic white spot lesion and the visible labial tooth surface were outlined on standardized clinical photographs and measured using ImageJ. The lesion-area ratio was calculated as R (%) = (lesion area / total visible labial surface area) × 100. Scores range from 0% to 100%, with lower values indicating a smaller visible lesion area and better lesion masking.
Time frame: At baseline and four post-treatment assessments through 6 months (T0-T4)
Plan to share: No
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Ran from Jun 2023 to primary completion in Jun 2025, 24 months.
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Hue University of Medicine and Pharmacy