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临床试验/NCT07806214
NCT07806214已完成不适用

Evaluation of Fluorescent Properties and Color Stability of 2 Different Composite Materials Used For Clear Aligner Attachments

Marmara University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2025年4月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Within-patient difference between composites in ΔE₀₀(color difference)

研究概览

简要总结

This split mouth study aims to evaluate whether 2 different composite materials used for making clear aligner attachments change color over time and do they have different fluorescent characteristics when illuminated with ultraviolet light.

While bonding the attachments, a coin toss will determine which composite resin will be used for upper right segment. The remaining quadrants will be bonded with alternating composite resin. After bonding extraoral photographs under ultraviolet light with cheek retractors will be taken for fluorescence evaluation. Intraoral scans will be performed immediately after bonding and every two months up to six months for evaluating color change.

详细描述

In this study, attachments will be divided into two groups in a split-mouth design. To ensure randomization, dental arch will be divided into four quadrants, and the composite to be applied to the upper-right quadrant will be determined by a coin toss. The alternative composite will then be applied to the opposing quadrant. Two routinely available flowable composite materials in our department, manufactured specifically for clear aligner attachments, will be used (AlignerFlow LC, VOCO GmbH, Cuxhaven, Germany; AlignerConnect, GC, Tokyo, Japan). Following the application of the materials in accordance with the manufacturers' instructions, excess material will be removed under ultraviolet light using a carbide bur. Patients will be instructed to change their clear aligners every 10 days and wear them for at least 20 hours per day. Patients will be asked to remove the aligners only during meals, brush their teeth after eating, and reinsert them immediately. Oral hygiene instruction will be provided to all patients.After bonding, extraoral photographs will be captured under UV light and saved in JPEG format. These photographs will be transferred into the "Adobe Photoshop CC 2020" software. Brightness differences between the tooth surface and the attachment surface will be measured using the "Color Picker" tool within the software. Immediately after attachment placement and at two-month intervals throughout six months, digital scans will be obtained using an intraoral scanner (Trios 3, 3Shape Trios A/S, Copenhagen, Denmark). Using the shade-selection feature of the software, attachment shades will be recorded.

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
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving Invisalign treatment at the Clinic of the Department of Orthodontics, Faculty of Dentistry, Marmara University
  • Mild to moderate crowding
  • Exhibiting good oral hygiene
  • No active dental caries
  • Voluntarily agreeing to participate in the study and signing the written informed consent form
  • Having no history of any syndrome, systemic disease, or allergy

排除标准

  • Being pregnant or lactating
  • Presenting with advanced periodontal disease of a severity that could affect orthodontic treatment
  • Having prosthetic restorations within the oral cavity
  • Presenting with white spot lesions prior to orthodontic treatment

研究组 & 干预措施

Upper Right Segment GC

Experimental

Patient's upper right segment will be bonded with GC Aligner Connect. Upper left VOCO, lower left GC, lower right VOCO.

干预措施: GC Aligner Connect (Procedure)

Upper Right Segment VOCO

Experimental

Patient's upper right segment will be bonded with VOCO AlignerFlow LC. Upper left GC, lower left VOCO, lower right GC.

干预措施: VOCO AlignerFlow LC (Procedure)

结局指标

主要结局

Within-patient difference between composites in ΔE₀₀(color difference)

时间窗: From initial treatment to six months

Shade codes acquired with scanner software was converted to CIE L\*, a\*, b\* values using the table published by Budde et al(2024). Color change from beginning to 6 months was calculated using CIEDE2000 formula.

Within-patient difference between materials in fluorescent contrast

时间窗: Baseline

Extraoral photographs under ultraviolet light were analysed in Adobe Photoshop 2020 (Adobe Systems Inc., San Jose, CA, USA). The L\* coordinate was recorded using the colour sampler at the geometric centre of each attachment and at the centre of adjacent unbonded enamel on the same tooth. Fluorescent contrast was defined as ΔL\* = L\*attachment - L\*enamel.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İsmail Çevik

DDS

Marmara University

研究点 (1)

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