Resin Infiltration Versus Microabrasion Combined With CPP-ACP for Masking Fluorotic Anterior White Spot Lesions: A 6-Month Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- CIELAB Color Difference Between the Fluorotic Lesion and Adjacent Sound Enamel
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
CIELAB Color Difference Between the Fluorotic Lesion and Adjacent Sound Enamel
时间窗: At baseline and four post-treatment assessments through 6 months (T0-T4)
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.
Fluorotic Lesion-Area Ratio on the Labial Tooth Surface
时间窗: At baseline and four post-treatment assessments through 6 months (T0-T4)
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.
次要结局
未报告次要终点
研究者
Le Van Nhat Thang
Principal Investigator
Hue University of Medicine and Pharmacy