Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05194956
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2022-01-04
Brief Title:
Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions
Sponsor:
University Hospitals of Derby and Burton NHS Foundation Trust
Organization:
University Hospitals of Derby and Burton NHS Foundation Trust
Study Overview
Official Title:
Orthodontic Patient Experience of Intraoral Scanners Versus Alginate Impressions in the UK a Single-Centre Randomised Controlled Crossover Trial
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPESI
Brief 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 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 patients 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 impressionsintraoral scans in the last 2 years Patients with cleft lip andor palate or recent research involvement will be excluded
OUTCOMES A modified visual analogue scale will be used to measure patient and operator reported outcomes eg patient comfort operator confidence perceived time taken and induction of coughgag 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
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 impressionsintraoral scans in the last 2 years Patients with cleft lip andor palate or recent research involvement will be excluded
OUTCOMES A modified visual analogue scale will be used to measure patient and operator reported outcomes eg patient comfort operator confidence perceived time taken and induction of coughgag 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
Detailed Description:
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 andor 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 consentassent the following procedure will be followed
One unit will be set up with an operator and a nurse
Participants in the alginate impression group
1 The unit the participant will be treated in will be set up appropriately with relevant materials ready
The alginate to be used will be Zhermack orthoprint orthodontic alginate material
2 A timer will be started when the participant is seated in the chair
3 The operator will carry out the impression as normal
Tray selection
Alginate mixing
Tray seating
Alginate setting
Tray removal
Wax bite
Clean up of the participants face
4 The timer will be stopped
5 Questionnaires
Participant will be asked to complete a questionnaire modified VAS using pictorial anchors
Operator will be asked to complete a questionnaire
6 These will be collected for analysis
7 The participant will then have records taken as part of their normal orthodontic care if not done already - a discussion to consent patient for orthodontic treatment
8 The participants will return a minimum 4 weeks later for a second appointment if they have not had an intraoral scan already in which they will undertake the process for Participants in the intraoral scanner group
Participants in the intraoral scanner group
1 The unit the participant will be treated in will be set up appropriately with relevant materials ready The interchangeable covering will be placed over the scanner ready for use
The intraoral scanning device to be used will be Trios 3 intraoral scanner 3Shape
The staff will be appropriately trained and will be requested to carry out a minimum of 10 scans prior to the study beginning
2 A timer will be started when the participant is seated in the chair
3 The scan will be carried out as per the manufacturers directions to include a full mouth scan and bite registration and saved on the scanner system
4 The timer will be stopped
5 Questionnaires
Participant will be asked to complete a questionnaire modified VAS using pictorial anchors
Operator will be asked to complete a questionnaire
6 These will be collected for analysis
7 The participant will then have records taken as part of their normal orthodontic care if not done already - a discussion to consent patient for orthodontic treatment - fit of any orthodontic appliance required
8 The participants will return a minimum 4 weeks later for a second appointment if they have not had an alginate impression already in which they will undertake the process for Participants in the alginate impression group
A minimum of 4 weeks between the two appointments allows for an adequate washout period and it also fits with orthodontic laboratory work timelines within the hospital
Once all participant data is obtained the operators will be asked a single question to indicate their preference towards a single method
Any participant andor their parent or guardian if appropriate who wishes to withdraw at any point during the trial can do so without reason and without this affecting or prejudicing the delivery of their orthodontic care
Analyses
Primary outcome - the difference between the paired visual analogue scale VAS scores will be compared using analysis of variance ANOVA that will analyse the period treatment and sequence effects of the comfort scores
Secondary outcomes - the 8 secondary outcomes measured by VAS and the time taken to make the impression or complete the scan will be compared using analyses of variance suitable for a crossover study that will test the period treatment and sequence effects on these nine secondary outcomes The operators preference will be reported using descriptive statistics The frequency and percentages will be recorded
Only the primary analysis will be compared against a specific level of significance The secondary analyses should be considered as hypothesis generating rather than providing firm conclusions
Once the participant has provided appropriate consentassent the following procedure will be followed
One unit will be set up with an operator and a nurse
Participants in the alginate impression group
1 The unit the participant will be treated in will be set up appropriately with relevant materials ready
The alginate to be used will be Zhermack orthoprint orthodontic alginate material
2 A timer will be started when the participant is seated in the chair
3 The operator will carry out the impression as normal
Tray selection
Alginate mixing
Tray seating
Alginate setting
Tray removal
Wax bite
Clean up of the participants face
4 The timer will be stopped
5 Questionnaires
Participant will be asked to complete a questionnaire modified VAS using pictorial anchors
Operator will be asked to complete a questionnaire
6 These will be collected for analysis
7 The participant will then have records taken as part of their normal orthodontic care if not done already - a discussion to consent patient for orthodontic treatment
8 The participants will return a minimum 4 weeks later for a second appointment if they have not had an intraoral scan already in which they will undertake the process for Participants in the intraoral scanner group
Participants in the intraoral scanner group
1 The unit the participant will be treated in will be set up appropriately with relevant materials ready The interchangeable covering will be placed over the scanner ready for use
The intraoral scanning device to be used will be Trios 3 intraoral scanner 3Shape
The staff will be appropriately trained and will be requested to carry out a minimum of 10 scans prior to the study beginning
2 A timer will be started when the participant is seated in the chair
3 The scan will be carried out as per the manufacturers directions to include a full mouth scan and bite registration and saved on the scanner system
4 The timer will be stopped
5 Questionnaires
Participant will be asked to complete a questionnaire modified VAS using pictorial anchors
Operator will be asked to complete a questionnaire
6 These will be collected for analysis
7 The participant will then have records taken as part of their normal orthodontic care if not done already - a discussion to consent patient for orthodontic treatment - fit of any orthodontic appliance required
8 The participants will return a minimum 4 weeks later for a second appointment if they have not had an alginate impression already in which they will undertake the process for Participants in the alginate impression group
A minimum of 4 weeks between the two appointments allows for an adequate washout period and it also fits with orthodontic laboratory work timelines within the hospital
Once all participant data is obtained the operators will be asked a single question to indicate their preference towards a single method
Any participant andor their parent or guardian if appropriate who wishes to withdraw at any point during the trial can do so without reason and without this affecting or prejudicing the delivery of their orthodontic care
Analyses
Primary outcome - the difference between the paired visual analogue scale VAS scores will be compared using analysis of variance ANOVA that will analyse the period treatment and sequence effects of the comfort scores
Secondary outcomes - the 8 secondary outcomes measured by VAS and the time taken to make the impression or complete the scan will be compared using analyses of variance suitable for a crossover study that will test the period treatment and sequence effects on these nine secondary outcomes The operators preference will be reported using descriptive statistics The frequency and percentages will be recorded
Only the primary analysis will be compared against a specific level of significance The secondary analyses should be considered as hypothesis generating rather than providing firm conclusions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None