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临床试验/NCT06259214
NCT06259214已完成不适用

Aesthetic Efficacy of Resin Infiltration Using Different Conditioning Methods: 24-Month Results

Ondokuz Mayıs University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
color change

研究概览

简要总结

Objective: To assess color and fluorescence changes in white spot lesions (WSLs) using different surface conditioning methods prior to resin infiltration: 24-months follow-up Methods: Thirty patients with each at minimum four WSLs after bracket debonding were included. After baseline fluorescence and color measurements, the lesions were randomly divided into four groups (n = 30): G1 (control): regular brushing, G2: 15% HCl gel (Icon Etch), G3: 37% H3PO4 gel (Scotchbond Etchant), G4: Er:YAG laser (Fotona AT Fidelis III). The lesions were desiccated with Icon Dry and then Icon Infiltrant (DMG) was applied. In the treatment groups, color and fluorescence were examined at baseline (T0), just after the resin infiltration treatment (T1), and after 6 (T2) and 24 months (T3). In the control group, the examinations were performed at baseline (T0) and after 6 (T2) and 24 months (T3).

详细描述

Prior to the study an experienced investigator (EK) attended a training and calibration session (k value = 0.88) and evaluated the severity of WSLs under direct illumination using a dental lamp with the aid of a standard 3.0× loupe (Keeler, Windsor, UK). Isolation was achieved with a cotton roll and suction. For the visual severity evaluation, all teeth were cleaned and air dried for 5 s and each lesion was scored according to ICDAS II free smooth-surface criteria [20]. Lesions with code 1 (first visual change after prolonged air drying) and code 2 (distinct visual changes without air drying) were included. The teeth were cleaned with a rubber cup and pumice, rinsed, and air dried (each for 30 s).

The same investigator (EK) used a DIAGNOdent Pen 2190 (Kavo, Biberach, Germany) to score each lesion afterwards. Before every scoring session, the device was calibrated using the standard ceramic according to the manufacturer's instructions. The teeth were rinsed and air dried before registration and a type B probe tip was positioned on the buccal surface of the tooth and rotated around its vertical axis until the peak reading was displayed on the panel. All measurements were taken 3 times and the average fluorescence value was recorded.

Out of 40 consecutive patients between 14 and 21 years of age who had just finished their fixed orthodontic treatment, 4 patients declined to participate in the trial and 6 patients did not meet the inclusion criteria, and 30 patients (18 females, 12 males, aged 15-19 years, mean age 17.1 years) with at least four WSLs on the buccal surfaces after bracket debonding were included in the trial. Patients with any systemic disease, bad oral hygiene, a smoking habit, enamel hypoplasia, staining, fluorosis, or restoration or cavity in any teeth with WSLs were excluded from the study. At the end of the clinical examination a total of 120 non-cavitated, unrestored WSLs after multibracket treatment on the buccal surfaces of the anterior and premolar teeth in the upper and lower jaws of 30 patients were included.

A spectrophotometer (SpectroShade; Medical High Technologies, Italy) was used to measure color parameters in the same examination room with standardized light conditions. The spectrophotometer was calibrated before the measurements of each specimen using a standard white background. The mouth piece attached to the intraoral camera of the spectrophotometer was placed at 90° on the alveolar process above each tooth. After correct placement of the optic handpiece, the examiner checked that the tooth appeared in the center of the yellow target box on the computer screen, and the opposing teeth, the tongue, and lips were not visible on the screen. The results from each tooth obtained by spectrophotometer were recorded, with the mean values of L*, a*, and b* automatically calculated at three consecutive times by positioning the intraoral camera, removing it, and then repositioning it. Three consecutive readings were taken using the spectrophotometer and the mean values were recorded.

Treatment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • at least four white spot lesions on the buccal surfaces after bracket debonding

排除标准

  • any systemic disease bad oral hygiene smoking habit enamel hypoplasia staining fluorosis restoration or cavity in any teeth with white spot lesions

结局指标

主要结局

color change

时间窗: 24 month

A spectrophotometer (SpectroShade; Medical High Technologies, Italy) was used to measure color parameters. The spectrophotometer was calibrated before the measurements of each specimen using a standard white background. The mouth piece attached to the intraoral camera of the spectrophotometer was placed at 90° on the alveolar process above each tooth. After correct placement of the optic handpiece, the examiner checked that the tooth appeared in the center of the yellow target box on the computer screen, and the opposing teeth, the tongue, and lips were not visible on the screen. The results from each tooth obtained by spectrophotometer were recorded, with the mean values of L\*, a\*, and b\* automatically calculated at three consecutive times by positioning the intraoral camera, removing it, and then repositioning it. Three consecutive readings were taken using the spectrophotometer and the mean values were recorded.Higher values indicate more color change.

fluorescence loss

时间窗: 24 monrth

DIAGNOdent Pen 2190 (Kavo, Biberach, Germany) was used to score each lesion . Before every scoring session, the device was calibrated using the standard ceramic according to the manufacturer's instructions. The teeth were rinsed and air dried before registration and a type B probe tip was positioned on the buccal surface of the tooth and rotated around its vertical axis until the peak reading was displayed on the panel. All measurements were taken 3 times and the average fluorescence value was recorded. Higher DIAGNOdent Pen values indicate deeper caries and the difference between the values obtained at different time intervals and the initial value indicates the amount of change in the loss of fluorescence of the lesions

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Emel Karaman

Assoc.Prof. Emel Karaman

Ondokuz Mayıs University

研究点 (2)

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