Clinical and Laboratory Effectiveness of Different Toothpastes in Treating White Spot Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- the size
研究概览
简要总结
This randomized clinical trial and laboratory study was conducted to:
Compare the effectiveness of zinc-carbonated nano-hydroxyapatite, arginine, and fluoride-containing toothpastes for treating white spot lesions associated with orthodontically treated teeth by using:
- Computerized image software analysis.
- Energy dispersive X-ray analysis.
详细描述
White spot lesions (WSLs), defined as "white opacity," occur as a result of subsurface enamel demineralization that is located on smooth surfaces of teeth. The reason for the white appearance is the changes in light-scattering optical properties of the decalcified enamel. The aim of the current study is to compare the effectiveness of zinc-carbonated nano-hydroxyapatite, arginine, and fluoride-containing toothpastes for treating white spot lesions.
A) Primary Objective
Assessment of:
size and color change measurements of the WSLs through digital photography and computerized image software analysis.
B) Secondary Objectives
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
- Double (Participant, Outcomes Assessor)
盲法说明
The toothpastes are sourced from international markets, and both the participants and the outcome assessor will remain unaware of the active remineralizing agent in the toothpaste. This ensures that neither the participants nor the outcome assessor will be informed about the assigned intervention, preventing their expectations from influencing the study results.
The examiner was blinded to participants' codes and previous WSL scores during dental assessments. However, blinding to the type of toothpaste used was not possible. Blinding during image analysis was also unfeasible, but this limitation was deemed manageable since the outcome relied on objective computer-based data, minimizing potential bias
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completion of fixed appliance therapy within the past 1 week.
- •Presence of at least one post-orthodontic white spot lesion on the labial surfaces of the six maxillary anterior teeth with a score of 1 or 2 on International Caries Detection and Assessment System (ICDAS II).
排除标准
- •Previous or planned treatment of WSLs.
- •Cavitated enamel surface.
- •Teeth with any composite restorations, veneers, crowns.
- •Surface defects (developmental defects, fluorosis, intrinsic and extrinsic discolorations, etc.).
- •Smoking habits.
结局指标
主要结局
the size
时间窗: 1) Baseline 2) 3-month evaluation 3) 6-month evaluation
Photographic assessment of the images will be done for quantifying the size (in mm2) of the white spot lesions and the affected tooth's labial surface by using an image processing software, ImageJ analysis software and to ensure accuracy of values, image calibration will be carried out, and the scale of the image analysis software will be pre-set. After the software calculates the values of the entire area of the tooth and the size of the WSL, the area affected by white spot lesions will be expressed as a percentage of the total tooth surface: WSLs %= Area of WSL/ Area of the labial tooth surface\*100.
the color change
时间窗: 1) Baseline 2) 3-month evaluation 3) 6-month evaluation
Using the Standardized CIE Lab\* system within Adobe Photoshop software, L\*a\*b values will be analyzed for each tooth and the color changes between carious and healthy enamel (∆E\*ab), as well as changes between different time points (∆E\*ab), will be calculated by = Δ E = (Δ L 2 + Δ a2 + Δ b2) ½. ΔE values between 1 and 3.7 are not only acceptable but also often go unnoticed in various colors, especially darker shades. Conversely, when ΔE exceeds 3.7, the color change could be clinically visible, indicating a noticeable color mismatch. According to the degrees of color changes evaluated 6 months after treatment, the teeth will be divided into the following three types: Type 1: The whitish, opaque color is completely masked Type 2: The whitish opaque color is partially masked but not completely Type 3: The whitish opaque color shows little
次要结局
- Evaluation of the remineralizing ability of each agent(1 month)