Orthodontic Patient Experience of Intraoral Scanners Versus Alginate Impressions in the UK: a Single-Centre Randomised Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Orthodontic Patient Comfort
研究概览
简要总结
CONTEXT: Digital scanning systems are becoming more and more popular with the advent of the COVID-19 pandemic. The risks surrounding aerosol-generating procedures (AGP) has resulted in practitioners changing their normal practice and finding alternative methods to continue managing their patients. Digital (intraoral) scanners are often used to show patients treatment options and help in educating them regarding their oral hygiene as it produces an almost instant digital image of their teeth. Conventional methods using alginate impressions produce study models which are created in dental plaster or stone, involving a lab cost and a greater environmental impact but remain a popular method of recording a patient's teeth and bite.
OBJECTIVE: To investigate patient experience, operator experience and preference in intraoral scanning versus alginate impression taking in the orthodontic setting.
DESIGN, SETTING AND SUBJECTS: A randomised controlled two-period crossover trial to be conducted in a UK secondary care setting involving 84 participants ready to start orthodontic treatment, with no experience of impressions/intraoral scans in the last 2 years. Patients with cleft lip and/or palate or recent research involvement will be excluded.
OUTCOMES: A modified visual analogue scale, will be used to measure patient and operator reported outcomes (e.g. patient comfort, operator confidence, perceived time taken and induction of cough/gag reflex) following an alginate impression or an intraoral scan using Trios® 3 intraoral scanner (3Shape). The time taken for each procedure will also be measured. Lastly, operator preference will be recorded.
CONCLUSION: The proposed study aims to add to the limited evidence base, providing information regarding the use of intraoral scanners compared to alginate impressions from both the orthodontic patient and operator perspectives.
详细描述
Eligible patients are to be identified during a virtual dental health education (DHE) appointment prior to their orthodontic treatment commencing. With consent, the trial will be discussed with patients meeting the inclusion criteria and they will be provided with relevant trial information in both leaflet and video format. The potential participant and/or their parent or guardian will be allowed time (3 weeks) to consider the information and ask any relevant questions. If they choose to take part in the trial, they will be recruited and allocated randomly into mixed block sizes using an online randomisation tool. If they choose not to participate, normal orthodontic care will continue. For children, unable to consent for themselves, assent will also be sought.
Once the participant has provided appropriate consent/assent, the following procedure will be followed:
• One unit will be set up with an operator and a nurse
Participants in the alginate impression group:
- The unit the participant will be treated in, will be set up appropriately with relevant materials ready.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New patients, aged 10 years and old, attending the Royal Derby Hospital orthodontic department, requiring study model impressions taken prior to commencing orthodontic treatment
- •Participants must be capable of giving informed consent, or have an acceptable individual capable of giving consent on the patient's behalf (e.g. parent or guardian of a child under 16 years of age).
排除标准
- •Patients who have had previous experience of impressions/intraoral scans in the last 2 years
- •Cleft lip and/or palate patients
- •Patient who have been involved in a study in the last 6 months or are currently part of a study
研究组 & 干预措施
Arm 1 - Alginate impressions followed by digital intraoral scan
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
干预措施: Intraoral scan (Procedure)
Arm 1 - Alginate impressions followed by digital intraoral scan
The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
干预措施: Alginate impressions (Procedure)
Arm 2 - Digital intraoral scan followed by alginate impressions
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
干预措施: Intraoral scan (Procedure)
Arm 2 - Digital intraoral scan followed by alginate impressions
The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.
干预措施: Alginate impressions (Procedure)
结局指标
主要结局
Orthodontic Patient Comfort
时间窗: Immediately following intervention
A 100mm modified Visual Analogue Scale (VA scale) measuring patient comfort during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience. Minimum value: 0, Maximum value: 100
次要结局
- Experience of Pain(Immediately following intervention)
- Relative Speed of Impression(Immediately following intervention)
- Nausea and/or Coughing(Immediately following intervention)
- Likely Recommendation(Immediately following intervention)
- Ease of Impression for the Operator(Immediately following intervention)
- Confidence Taking the Impression for the Operator(Immediately following intervention)
- Relative Speed of Impression for the Operator(Immediately following intervention)
- Operator Experience of Sickness or Coughing(Immediately following intervention)
- Chairside Time Taken to Complete Impression Method(Immediately following intervention)
- Operator Preference(Immediately following completion of participant data collection)