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临床试验/NCT03405961
NCT03405961已完成不适用

A Single-site Self-controlled Comparative Study of Conventional Versus Digital Peer Assessment Rating (PAR) Using the Carestream (CS) 3600 Intraoral Scanner in Orthodontic Patients

King's College London1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Peer Assessment Rating (PAR) score

研究概览

简要总结

In dentistry, Peer Assessment Rating (PAR) is an objective way of quantifying how maligned a patient's teeth are by scoring orthodontic study models. It can also be used to assess treatment outcome by comparing pre- and post-treatment scores. Traditionally, PAR scoring is performed manually on plaster casts by a trained and calibrated individual. The plaster casts consume considerable amounts of storage space and the process of manual scoring can be time consuming and expensive. The recent decades have seen a rise in popularity of intra oral scanners in dentistry to produce digital study models. These obviate the need for physical storage space and a software can be used to calculate PAR scores more conveniently and at a faster speed. A review of the current literature showed that the CS 3600 intra oral scanner by Carestream Dental demonstrated acceptable accuracy for clinical use.

In this study, patients will receive the usual impressions and their moulds will be PAR scored manually (usual care pathway). In addition, they will also receive intra oral scans with Carestream 3600 and the digital models will be scored by a computer. Manual and digital scores will be compared and analysed for any significant discrepancies.

详细描述

CS 3600 intra oral scanner is already licenced for the use in dentistry and is routinely used by some dental practitioners to substitute conventional impressions and plaster models in restorative, implant and orthodontic diagnosis and treatment planning. The scanner is 220 x 38 x 58 mm in size and operates with video capture technology. It emits no radiation.

Peer Assessment Rating (PAR) is an objective way of quantifying how severe a malocclusion is by scoring orthodontic study models. It can also be used to assess treatment outcome. All National Health Service (NHS) orthodontic providers in the United Kingdom are contractually bound to submit PAR score changes for at least 20 of their treated cases plus 10% of the remainder of their case load every year. Traditionally, PAR scoring is performed manually on plaster casts by a trained and calibrated individual. The plaster casts must be retained as part of the patient's medical records and hence consume considerable amounts of storage space. The process of manual scoring is also time intensive. Digital models obviate the need for physical storage space and a software can be used to calculate PAR scores more conveniently and at a faster speed. A review of the current literature showed that the CS 3600 intra oral scanner by Carestream Dental demonstrated acceptable accuracy for clinical use. The purpose of this study is to assess the accuracy of PAR scores obtained from digital models with those obtained manually from conventional models for the same patient at one given point in time.

Aims: Against this background, the aim of this study is to compare digital PAR scoring using the CS 3600 intraoral scanner with conventional PAR scoring.

Objectives: The objectives are to investigate whether PAR scoring on models acquired through direct and indirect digitisation produces any significant errors when compared with conventional PAR scoring on plaster models. The study will also seek to measure the chairside time taken to produce upper and lower full arch scans and bite registration with CS 3600 versus the time taken to produce equivalent alginate impressions and wax bite. Furthermore, the time taken for digital scoring will be measured and compared with the conventional method. Finally, patient preference with regard to intraoral scans versus impressions will be investigated.

Method: The sample size was confirmed using a power calculation. The sample will consist of 66 orthodontic patients at Kingston Hospital, excluding any patients with fixed appliances or bonded components. All patients will receive conventional impressions as well as intraoral scans, serving as their own controls. Plaster casts poured from the impressions will also be scanned to produce indirect digital models. PAR scoring will then be performed by one investigator on all three models (plaster casts, direct and indirect digital models) for comparison. A second investigator will record the time taken to perform scans and impressions as well as the time taken to complete digital and conventional scoring. Immediately after the clinical procedure patients will be given a questionnaire evaluating their preference.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
11 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing orthodontic treatment at Kingston Hospital
  • Patients who have completed their orthodontic treatment and are attending for retainer reviews at Kingston Hospital

排除标准

  • patients with fixed or bonded appliances
  • age <11 or >50
  • Inability to gain informed consent due to communication barriers

结局指标

主要结局

Peer Assessment Rating (PAR) score

时间窗: 6 months

PAR score is an objective and standardised way of quantifying how much the position of teeth deviate from an ideal. Sub-scores are given in 5 categories assessing the position of teeth to adjacent teeth in same jaw as well as the opposing jaw. The sub scores are weighted according to their importance as described by Richmond et al. (1992) and then added to give a total score. Total scores may range from 2 to approximately 50. The higher the score, the greater the deviation from ideal.

次要结局

  • The length of time (in minutes) taken to obtain conventional impressions(6 months)
  • The length of time (in minutes) taken to obtain digital scans(6 months)
  • The cost involved in creating digital scans(6 months)
  • The cost involved in creating conventional models(6 months)
  • Do patients prefer conventional impressions or intraoral scans?(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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