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临床试验/NCT02364414
NCT02364414已完成不适用

The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models

Kettering General Hospital NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widths

研究概览

简要总结

The purpose of this study is to compare the accuracy of measurements derived from a commercially available direct intra-oral scanning system with those taken from plaster study models, and to compare cost implications of both systems.

The investigators will test the hypotheses:

  • There is no systematic difference between measurements taken from the Trios scanner and study models.
  • There is no difference in the cost of producing digital models.

详细描述

Plaster study models produced from moulds of the teeth are a standard component of orthodontic records. They are fundamental to diagnosis and treatment planning, evaluation of treatment progress and results as well as record keeping. (Santoro et al., 2003) Plaster models must be retained for a minimum of 11 years for a medico legal reasons. This leads to problems of storage in terms of space and cost, in addition to the risk of damage because of the brittle nature of the models. These problems therefore highlight the need for an alternative method for producing and storing study models. This study aims to compare the accuracy of measurements derived from a new commercially available direct intra-oral (inside of the mouth) scanning system (3Shape TRIOS (R)) with those taken from plaster study models, and to compare cost implications of both systems. We will use the results to conclude whether direct intra¬oral scanning can replace traditional plaster models produced from moulds of the teeth.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age range 11 years old to 18 years old.
  • Orthodontic patients with a range of malocclusions.
  • Dentition without abnormal morphology.
  • Adult/permanent dentition from the first molar to first molar in both arches.

排除标准

  • Patients under 11 years old and over 18 years old.
  • Carious teeth or teeth with significantly altered anatomy.
  • Periodontal disease with significant gingival swelling.

结局指标

主要结局

Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widths

时间窗: Within six weeks of initial intervention

All dental study models, and 3D scans will have all the above measurements carried out. There are 22 patients and each will have had study models made and these will be measured twice on two separate occasions, and all scans measured twice. The measurements will be compared and analysed to see if the 3D scans accurately represent the tooth sizes and measurements that have been carried out on the dental study models (gold standard).

次要结局

  • Cost(within 6 months of initial intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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