Orthodontic Patient ExperienceOPESINCT05194956
Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions
A study testing Intraoral scan and Alginate impressions in people with Orthodontic Patient Experience, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Patient Experience
- What is being tested?
- Intraoral scan and Alginate impressions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2022to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orthodontic Patient Experience of Intraoral Scanners Versus Alginate Impressions in the UK: a Single-Centre Randomised Controlled Crossover Trial
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.
Read more
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.
Read the 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 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.
- The alginate to be used will be: Zhermack orthoprint® orthodontic alginate material
- A timer will be started when the participant is seated in the chair
- 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 participant's face
- The timer will be stopped
- Questionnaires
- Participant will be asked to complete a questionnaire (modified VAS using pictorial anchors)
- Operator will be asked to complete a questionnaire
- 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.
- 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
- 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
- Participant will be asked to complete a questionnaire (modified VAS using pictorial anchors)
- Operator will be asked to complete a questionnaire
- 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:
- 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 operator's 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.
- Conditions
- Orthodontic Patient Experience
- Being tested
- Intraoral scan, Alginate impressions
- Keywords
- Orthodontic Patient, Intraoral Scan, Alginate impression, Conventional impression, Digital scan, Patient experience, Patient comfort, Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral scanProcedure or surgery
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 impressionsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intraoral scan; Procedure: Alginate impressions |
| 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. Receives: Procedure: Intraoral scan; Procedure: Alginate impressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately following intervention
Secondary outcomes (10)
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
Measured: Immediately following intervention
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately following intervention
Chairside Time Taken to Complete Impression Method
A quantitative time measure will be recorded for each impression method
Measured: Immediately following intervention
Operator Preference
A simple question to determine operator preference for intraoral scanning versus alginate impressions.
Measured: Immediately following completion of participant data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start31 May 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orthodontic Patient ExperienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-centre prospective randomised controlled two-period crossover study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British Orthodontic Society Foundation, Derby Pump Priming Charitable Funds, Derby Clinical Trials Support Unit
- Responsible party
- Sponsor
- Investigators
- Alison Murray, BDS, MSc, FDS RCPS, MOrth RCS, Principal investigator, University Hospitals of Derby and Burton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194956
- Sponsor's protocol ID
- UHDB/2021/022
- Acronym
- OPESI
- Status last verified
- Dec 2024
- First submitted
- 4 Jan 2022
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymised participant data will be shared on request e.g. for inclusion in a systematic review and meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthodontic Patient Experience of Intraoral Scanners Versus Alginate Impressions in the UK: a Single-Centre Randomised Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT05194956
- Acronym / sponsor ID
- OPESI / UHDB/2021/022
- Conditions
- Orthodontic Patient Experience
- Keywords
- Orthodontic Patient, Intraoral Scan, Alginate impression, Conventional impression, Digital scan, Patient experience, Patient comfort, Preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- British Orthodontic Society Foundation, Derby Pump Priming Charitable Funds, Derby Clinical Trials Support Unit
- Study start
- 31 May 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
- The alginate to be used will be: Zhermack orthoprint® orthodontic alginate material
- A timer will be started when the participant is seated in the chair
- 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 participant's face
- The timer will be stopped
- Questionnaires
- Participant will be asked to complete a questionnaire (modified VAS using pictorial anchors)
- Operator will be asked to complete a questionnaire
- 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.
- 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
- 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
- Participant will be asked to complete a questionnaire (modified VAS using pictorial anchors)
- Operator will be asked to complete a questionnaire
- 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:
- 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 operator's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre prospective randomised controlled two-period crossover study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Alginate impressions followed by digital intraoral scan | Experimental | Procedure: Intraoral scan, Procedure: Alginate impressionsThe 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 | Procedure: Intraoral scan, Procedure: Alginate impressionsThe 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral scanAn 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. | Procedure or surgery | Arm 1 - Alginate impressions followed by digital intraoral scan, Arm 2 - Digital intraoral scan followed by alginate impressions |
| Alginate impressionsAlginate 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. | Procedure or surgery | Arm 1 - Alginate impressions followed by digital intraoral scan, Arm 2 - Digital intraoral scan followed by alginate impressions |
Primary outcome
Orthodontic Patient Comfort
Time frame: 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
10 secondary outcomes
Experience of Pain
Time frame: Immediately following intervention
Relative Speed of Impression
Time frame: Immediately following intervention
Nausea and/or Coughing
Time frame: Immediately following intervention
Likely Recommendation
Time frame: Immediately following intervention
Ease of Impression for the Operator
Time frame: Immediately following intervention
Confidence Taking the Impression for the Operator
Time frame: Immediately following intervention
Relative Speed of Impression for the Operator
Time frame: Immediately following intervention
Operator Experience of Sickness or Coughing
Time frame: Immediately following intervention
Chairside Time Taken to Complete Impression Method
Time frame: Immediately following intervention
Operator Preference
Time frame: Immediately following completion of participant data collection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Only anonymised participant data will be shared on request e.g. for inclusion in a systematic review and meta-analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Murray, BDS, MSc, FDS RCPS, MOrth RCS principal investigator
University Hospitals of Derby and Burton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral scan and Alginate impressions in people with Orthodontic Patient Experience, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthodontic Patient Comfort (time frame: Immediately following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.