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临床试验/NCT06140043
NCT06140043已完成2 期

Augmented Reality for Orthognatic Surgery Patient Education

University Medical Center Groningen3 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
3
主要终点
Objective knowledge

研究概览

简要总结

To evaluate whether the use of augmented reality (AR) for visualizing 3D models can be a valuable addition to patient education regarding orthognathic procedures compared to using only 2D visualization (on a computer screen).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patients planned for an orthognathic intake consult in the period of July to april 2024 at the UMCU or UMCG or Uniklinik RTWH Aachen;
  • Patients with dentofacial deformity (dysgnathia) including: class II malocclusion, class III malocclusion, or open bite;
  • Patients undergoing treatment using BSSO (Bilateral Sagittal Split Osteotomy), Le Fort I, or BIMAX;
  • The planned treatment is either with or without a genioplasty procedures.
  • Patients 16 years of age or older.

排除标准

  • Patients with craniofacial syndromes, such as cleft lip and palate
  • Patient which require an osteotomy involving two or more segments

研究组 & 干预措施

Monitor

Active Comparator

Patient consultation with 3D models of bone and skin, seen with a monitor screen

干预措施: Patient consultation (Other)

Augmented Reality

Experimental

Patient consultation with 3D models of bone and skin, seen in augmented reality trough AR glasses

干预措施: Patient consultation (Other)

结局指标

主要结局

Objective knowledge

时间窗: Immediately after the regular first intake consult

Patient knowledge of the medical problem and proposed treatment, also measured by a questionnaire. Patient can get 2 points when all four question are right, if all questions are answered incorrectly, then -2 points

Patient satisfaction

时间窗: Immediately after the regular first intake consult

Patient satisfaction of the intake consult. Focussed on the explanation of the condition and proposed treatment, measured through a questionnaire. The questionnaire measures the clarity and importance of the information for the patient. For both parameters a median score will be calculated between 0 and 5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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