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临床试验/NCT06288386
NCT06288386已完成不适用

Impact of Dental Composite Viscosity on Attachment Accuracy: a Prospective Clinical Trial

University of Pavia2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年3月4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
10
试验地点
2
主要终点
Changes in the shape of attachments

研究概览

简要总结

The present study will be a single-center, split-mouth, randomized controlled clinical trial. Patients undergoing orthodontic treatment with Invisalign aligners will be enrolled after signing the informed consent. Two different flowable composite resins will be evaluated for the performing of attachments using a split-mouth design:

  • group A: Filtek Supreme Flow (3M Unitek, Monrovia, Calif)
  • group B: Grandioso Heavy Flow (VOCO GmbH, Cuxhaven Germany)

Digital impressions with iTero intraoral scanner will be performed. The resulting 3D images will be superimposed onto the reference STL model, representing the pre- planned ideal attachment configuration. Digital scans will be used to assess any changes in shape of the attachments. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software.

详细描述

The present study will be a single-center, split-mouth, randomized controlled clinical trial. Patients willing to start Invisalign treatment or refinement phases will be recruited from the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy. Each patient will sign the informed consent before participation. The bonding procedure will be the following: isolation of the working field with the placement of a cheek retractor, enamel etching with 37% orthophosphoric acid, rinsing and drying, application of a thin layer of ScotchBond adhesive (3M Unitek, Monrovia, Calif) and light curing. Then, patient will be divided into groups A and B: in group A, attachments will be realized using Filtek Supreme Flow (3M Unitek, Monrovia, Calif) for teeth belonging to mandibular left and maxillary right quadrants, whereas in the remaining quadrants, they will be realized using Grandioso Heavy Flow (VOCO GmbH, Cuxhaven Germany. In group B, quadrants will be inverted. After the bonding of the attachments, digital impressions with iTero intraoral scanner will be performed. The resulting 3D images will be superimposed onto the reference STL model, representing the pre-planned ideal attachment configuration. Digital scans will be used to assess any changes in shape of the attachments. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software. For each of the five attachment surfaces the values obtained for the two composite resins will be compared using three key parameters: total mean discrepancy, mean of positive values only, and mean of negative values only. The analysis will be performed using R software, calculating descriptive statistics for each variable, including mean, standard deviation, median, minimum, and maximum values for each group. The normality of the distributions will be assessed using the Kolmogorov-Smirnov test. Subsequently, a t-test will be applied for inferential analysis of each variable.

For all tests, statistical significance will be set at P<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing Invisalign orthodontic treatment

排除标准

  • enamel demineralizations

研究组 & 干预措施

Higher filler content composite

Experimental

Attachments will be performed with a higher filler content flowable composite resin.

干预措施: GrandioSO Heavy Flow (Device)

Lower filler content composite

Active Comparator

Attachments will be performed with a lower filler content flowable composite resin.

干预措施: Filtek Z350XT Flowable (Device)

结局指标

主要结局

Changes in the shape of attachments

时间窗: Baseline

The shape changes of attachments will be evaluated through ZEISS Inspect software.

Change in excess of attachments

时间窗: Baseline

The excess of attachments will be evaluated through ZEISS Inspect software.

Change in defect of attachments

时间窗: Baseline

The defect of attachments will be evaluated through ZEISS Inspect software.

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

Andrea Scribante

Associate Professor, Principal Investigator

University of Pavia

研究点 (2)

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