OPESI Trial V1
Research type
Research Study
Full title
Orthodontic Patient Experience of Intraoral Scanners Versus Alginate Impressions in the UK: a Single-Centre Randomised Controlled Crossover Trial
IRAS ID
307434
Contact name
Trishna Patel
Contact email
Sponsor organisation
University Hospitals of Derby and Burton NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 3 days
Research summary
Research Summary
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 (intra-oral) 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.
Summary of Results
This study was carried out at the Royal Derby Hospital between the 19th April 2022 and 3rd January 2023 to identify whether orthodontic patients aged over 10 years old, found digital scans or tooth moulds more comfortable.
In total, 86 orthodontic patients participated in the study. They were split between two groups, with one group having the digital scan first (44 participants) and the tooth mould at a second appointment and the second group having the tooth mould first (42 participants) and the digital scan at a second appointment. After each type of 3D record, the participants and clinicians were asked to complete a questionnaire about their experience. Both of these groups were similar in terms of age, sex and ethnicity.
During the study, there were no reports of medical problems by participants or the researchers. There were 2 participants that decided not to continue with the study after having a digital scan taken.
In this study, participants found the digital scan significantly more comfortable than the tooth moulds. Although, participants did not appear to find one method particularly more painful than the other. Participants found the experience of feeling sick and/or coughing less in the digital scans. They were also more likely to recommend digital scans compared to the tooth moulds. Taking a digital scan was found to take longer (by about 2 minutes) than tooth moulds in both groups when measured using a digital timer. Participants also felt digitals scans took longer than tooth moulds.The results showed that records taken at the second appointment were generally faster than those taken in the first appointment. The results do not suggest that the clinicians treating the participants were more confident with taking one type of 3D record, although there is a suggestion that taking tooth moulds is faster and easier for the clinician. The clinicians also reported less sickness/coughing when taking digital scans compared to tooth moulds.
The results highlight that digital scans are more comfortable for patients than tooth moulds despite taking longer. In terms of the clinicians, 3 of 4 clinicians preferred the tooth moulds, specifying technical issues with the scanner as reasons for this choice. This was also reflected in the study results looking at the clinician’s questionnaire scores which showed they found tooth moulds easier and faster to take than the digital scans. This information is useful to know to help with development of digital pathways within orthodontics as well as trying to improve clinician acceptance. Future research could focus on the sustainability of both methods of record taking as well as looking at the differences in cost (time, storage and material costs).
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0038
Date of REC Opinion
15 Mar 2022
REC opinion
Further Information Favourable Opinion