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| Name | Class |
|---|---|
| British Orthodontic Society Foundation | UNKNOWN |
| Derby Pump Priming Charitable Funds | UNKNOWN |
| Derby Clinical Trials Support Unit | UNKNOWN |
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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.
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.
A timer will be started when the participant is seated in the chair
The operator will carry out the impression as normal:
The timer will be stopped
Questionnaires
These will be collected for analysis
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
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:
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.
A timer will be started when the participant is seated in the chair
The scan will be carried out as per the manufacturer's directions to include a full mouth scan and bite registration and saved on the scanner system.
The timer will be stopped
Questionnaires
These will be collected for analysis
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.
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 and/or 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Alginate impressions followed by digital intraoral scan | Experimental | 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. |
|
| Arm 2 - Digital intraoral scan followed by alginate impressions | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoral scan | Procedure | An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen. |
| Measure | Description | Time Frame |
|---|---|---|
| Orthodontic Patient Comfort | 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 | Immediately following intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Experience of Pain | A 100mm modified Visual Analogue Scale (VA scale) measuring pain 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 | Immediately following intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Murray, BDS, MSc, FDS RCPS, MOrth RCS | University Hospitals of Derby and Burton NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Derby Hospital | Derby | Derbyshire | DE22 3NE | United Kingdom |
Only anonymised participant data will be shared on request e.g. for inclusion in a systematic review and meta-analysis.
The study data is anticipated to become available following publication. Study data will be archived for 5 years from the end of the study.
Analyses within a meta-analysis would be considered if it has been approved through an independent review committee. Requests may be submitted up to 5 years from the end of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen. Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite. |
| FG001 | 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. Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen. Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period |
| |||||||||||||
| Period 2 |
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The primary analysis was intended to be completed on all patients, after imputing any missing data. However, the primary analysis was carried out on complete records only, although there were 2 patients who withdrew after their first procedure. The missing data for these two patients was not imputed because the imputation of two values using multiple imputation would not add any value to the statistical analysis or results. In addition, the required sample of 84 patients had been achieved.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen. Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Orthodontic Patient Comfort | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
|
Participants were assessed for adverse events across the 2 days in which they underwent intervention (either intraoral scan or alginate impression). There was a washout period of at least 4 weeks between these 2 days.
Adverse Event (AE) - Any untoward medical occurrence in a participant, including occurrences which are not necessarily caused by or related to study procedures.
Serious Adverse Event (SAE) - A serious adverse event is any untoward medical occurrence that:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alginate Impression | Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs Trishna Patel | University Hospitals of Derby and Burton NHS Trust | 01332340131 | 83556 | trishnaanil.patel@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2022 | Feb 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2022 | Feb 16, 2024 | SAP_001.pdf |
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Single-centre prospective randomised controlled two-period crossover study
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|
| Alginate impressions | Procedure | Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite. |
|
| Relative Speed of Impression |
A 100mm modified Visual Analogue Scale (VA scale) measuring relative speed 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 |
| Immediately following intervention |
| Nausea and/or Coughing | A 100mm modified Visual Analogue Scale (VA scale) measuring nausea and/or coughing 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 | Immediately following intervention |
| Likely Recommendation | A 100mm modified Visual Analogue Scale (VA scale) measuring likely recommendation and/or coughing 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 | Immediately following intervention |
| Ease of Impression for the Operator | A 100mm Visual Analogue Scale (VA scale) measuring ease of impression for the operator 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 | Immediately following intervention |
| Confidence Taking the Impression for the Operator | A 100mm Visual Analogue Scale (VA scale) measuring operator confidence 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 | Immediately following intervention |
| Relative Speed of Impression for the Operator | A 100mm Visual Analogue Scale (VA scale) measuring relative speed of impression for the operator 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 | Immediately following intervention |
| Operator Experience of Sickness or Coughing | A 100mm Visual Analogue Scale (VA scale) measuring operator experience of sickness or coughing during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more positive experience. Minimum value: 0, Maximum value: 100 | Immediately following intervention |
| Chairside Time Taken to Complete Impression Method | A quantitative time measure will be recorded for each impression method | Immediately following intervention |
| Operator Preference | A simple question to determine operator preference for intraoral scanning versus alginate impressions. | Immediately following completion of participant data collection |
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| NOT COMPLETED |
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| BG001 | 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. Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen. Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen. Alginate impressions: Alginate impressions are the conventional method of creating dental moulds for orthodontic records. A plastic tray is filled with an alginate material, which is placed into the mouth to take a mould of the teeth. This requires two moulds for both top and bottom arches. In addition, the participant would also bite into a warm piece of wax to record their bite. |
|
|
|
| Secondary | Experience of Pain | A 100mm modified Visual Analogue Scale (VA scale) measuring pain 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
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| Secondary | Relative Speed of Impression | A 100mm modified Visual Analogue Scale (VA scale) measuring relative speed 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
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|
| Secondary | Nausea and/or Coughing | A 100mm modified Visual Analogue Scale (VA scale) measuring nausea and/or coughing 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
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|
| Secondary | Likely Recommendation | A 100mm modified Visual Analogue Scale (VA scale) measuring likely recommendation and/or coughing 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
|
|
|
|
| Secondary | Ease of Impression for the Operator | A 100mm Visual Analogue Scale (VA scale) measuring ease of impression for the operator 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
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| Secondary | Confidence Taking the Impression for the Operator | A 100mm Visual Analogue Scale (VA scale) measuring operator confidence 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
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| Secondary | Relative Speed of Impression for the Operator | A 100mm Visual Analogue Scale (VA scale) measuring relative speed of impression for the operator 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
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| Secondary | Operator Experience of Sickness or Coughing | A 100mm Visual Analogue Scale (VA scale) measuring operator experience of sickness or coughing during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more positive experience. Minimum value: 0, Maximum value: 100 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately following intervention |
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| Secondary | Chairside Time Taken to Complete Impression Method | A quantitative time measure will be recorded for each impression method | Posted | Mean | 95% Confidence Interval | seconds (within-patient) | Immediately following intervention |
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| Secondary | Operator Preference | A simple question to determine operator preference for intraoral scanning versus alginate impressions. | This involved asking the 4 operators (clinicians) their overall preference for alginate impressions or intraoral scans during the clinical trial. | Posted | Count of Participants | Participants | Immediately following completion of participant data collection |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | Intraoral Scan | Intraoral scan: An intraoral scan is multiple images taken using an intraoral scanning device which results in a digital mould being taken of the participants mouth and bite. It works by systematically placing the scanner tip over the teeth and gums, whilst it constructs an image on screen. | 0 | 86 | 0 | 86 | 0 | 86 |
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| ANOVA | 0.8423 | Superiority | Sequence effects |
| ANOVA | 0.9544 | Superiority | Period effects |
| ANOVA | 0.3878 | Superiority | Sequence effects |
| ANOVA | 0.9772 | Superiority | Period effects |
| ANOVA | 0.1583 | Superiority | Sequence effects |
| ANOVA | 0.4709 | Superiority | Period effects |
| ANOVA | 0.5911 | Superiority | Sequence effects |
| ANOVA | 0.5825 | Superiority | Period effects |
| ANOVA | 0.0910 | Superiority | Sequence effects |
| ANOVA | 0.2278 | Superiority | Period effects |
| ANOVA | 0.9259 | Superiority | Sequence effects |
| ANOVA | 0.8225 | Superiority | Period effects |
| ANOVA | 0.9104 | Superiority | Sequence effects |
| ANOVA | 0.5194 | Superiority | Period effects |
| ANOVA | 0.1369 | Superiority | Sequence effects |
| ANOVA | 0.3366 | Superiority | Period effects |
| ANOVA | 0.8509 | Superiority | Sequence effects |
| ANOVA | 0.0355 | Superiority | Period effects |