Mouth, EdentulousToothPICKNCT03738189
Augmented Reality for Tooth Selection Augmented Reality for Tooth Selection
An observational study of Mouth, Edentulous, run by University of Leeds at 1 site in United Kingdom.
Trial summary
A questionnaire based study to investigate the effectiveness of an Augmented Reality App in the selection of teeth for dentures. Patients dentists and dental technicians are asked to assess the effectiveness of the App in structured questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- Augmented Reality Video
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2018to 14 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Edentulous patients receiving new dentures at Leeds Dental Hospital
Who may be able to join
- The patient, clinician and technician have capacity to give informed consent.
- The patient who is a potential participant has no natural upper anterior teeth.
- The patient who is a potential participant has capacity to read and understand the Participant Information Sheet, and questionnaire which are printed in English.
- The patient who is a potential participant is undergoing treatment for dentures within Leeds Dental Institute or the School of Dentistry at Leeds and has no natural upper anterior teeth
Who cannot join
- The clinical use of a wax 'occlusal record block' is not part of the treatment plan.
- The patient who is a potential participant has a visual impairment and indicates they cannot adequately assess the Augmented Reality (AR) image.
- Written consent to take part in the assessment is not simultaneously obtained from the patient, the clinician and the technician participating in the construction of the dentures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Dental Institute
Leeds, West Yorkshire, LS2 9LU
About this study
Official title: A Prospective Cohort Study of Augmented Reality for Tooth Selection
A questionnaire based study to investigate the effectiveness of an Augmented Reality App in the selection of teeth for dentures. Patients dentists and dental technicians are asked to assess the effectiveness of the App in structured questionnaires.
Read the detailed description
Background The selection of teeth for dentures has difficulties. The main problem is that patients find it hard to envisage how a particular shape or 'mold' of tooth will look in their mouth. They are currently shown a number of different shaped teeth asked to express their preference.
This research team has developed computer software which now offers an alternative way to assist patients in the selection of the different shaped teeth. The new method uses 'Augmented Reality' (AR) to show the patient a live image of themselves with a selection of teeth in position in the picture. Effectively the patient takes a live video 'selfie' and the image on the screen shows the chosen teeth in their smile. The investigators want to know if this new method of selection improves the process of tooth selection.
Investigation Design This is a prospective observational cohort study which follows selected patients over 2 clinical visits carrying out a questionnaire based investigation of the new Augmented Reality (AR) method to select teeth for dentures.
Objectives This aim of this research is to investigate the effectiveness of the technology. This will be undertaken using 5 questionnaire based outcome measures to be completed by patients, dentists and dental technicians.
Primary Objective The primary objective is to assess the use of Augmented Reality (AR) for tooth selection.
Secondary Objectives
The secondary objectives use structured questionnaires to determine:
- the patients' assessment of using the Augmented Reality (AR) for tooth selection.
- the clinicians' assessment of using the Augmented Reality (AR) for tooth selection
- the dental technicians assessment of using Augmented Reality (AR) for tooth selection
- the clinicians' assessment of the quality and reality of the images produced by the Augmented Reality (AR) for tooth selection
- the dentists' assessment of the quality and reality of the images produced by Augmented Reality (AR) for tooth selection
Number of Patients 30 patients will be recruited
Informed Consent Witten Informed consent will be obtained from each participant.
- Conditions
- Mouth, Edentulous
- Being tested
- Augmented Reality Video
- Keywords
- Dental Prosthesis Designs, Dentures, Denture Design, Denture, Complete, Upper, Technology, Dental, Aesthetics, Dental
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality VideoOther
Augmented Reality selfies will place a selection of denture teeth in pictures of the participants in order to enable the selection of their preferred teeth on their new denture.
What is being measured
The primary outcome is the main question the study is designed to answer.
A questionnaire to determine patients' assessment of Augmented Reality App
The patients' assessment of using the Augmented Reality (AR) for tooth selection will be analysed.
Measured: Up to 18 weeks from entering the study
Secondary outcomes (4)
A questionnaire to determine clinicians assessment of Augmented Reality App
The clinicians' assessment of using the Augmented Reality (AR) for tooth selection with a structured questionnaire.
Measured: Up to 18 weeks from entering the study
A questionnaire to determine technicians assessment of Augmented Reality App
The dental technicians assessment of using Augmented Reality (AR) for tooth selection with a structured questionnaire.
Measured: Up to 18 weeks from entering the study
A questionnaire to determine patients' perception of the reality of the Augmented Reality App
The patients assessment of the quality and reality of the images produced by the Augmented Reality (AR) for tooth selection by the use of a structured questionnaire
Measured: Up to 18 weeks from entering the study
A questionnaire to determine dentists' perception of the reality of the Augmented Reality App
The dentists' assessment of the quality and reality of the images produced by Augmented Reality (AR) for tooth selection by the use of a structured questionnaire
Measured: Up to 18 weeks from entering the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start10 Sep 2018
- Primary completion31 Dec 2019
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth, EdentulousStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Keeling, University of Leeds
- Investigators
- A J Keeling, BDS PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738189
- Sponsor's protocol ID
- UoL IRAS Project ID 238446
- Acronym
- ToothPICK
- Status last verified
- Nov 2020
- First submitted
- 9 Oct 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Augmented Reality for Tooth Selection
- ClinicalTrials.gov ID
- NCT03738189
- Acronym / sponsor ID
- ToothPICK / UoL IRAS Project ID 238446
- Conditions
- Mouth, Edentulous
- Keywords
- Dental Prosthesis Designs, Dentures, Denture Design, Denture, Complete, Upper, Technology, Dental, Aesthetics, Dental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A questionnaire based study to investigate the effectiveness of an Augmented Reality App in the selection of teeth for dentures. Patients dentists and dental technicians are asked to assess the effectiveness of the App in structured questionnaires.
Detailed description
Background The selection of teeth for dentures has difficulties. The main problem is that patients find it hard to envisage how a particular shape or 'mold' of tooth will look in their mouth. They are currently shown a number of different shaped teeth asked to express their preference.
This research team has developed computer software which now offers an alternative way to assist patients in the selection of the different shaped teeth. The new method uses 'Augmented Reality' (AR) to show the patient a live image of themselves with a selection of teeth in position in the picture. Effectively the patient takes a live video 'selfie' and the image on the screen shows the chosen teeth in their smile. The investigators want to know if this new method of selection improves the process of tooth selection.
Investigation Design This is a prospective observational cohort study which follows selected patients over 2 clinical visits carrying out a questionnaire based investigation of the new Augmented Reality (AR) method to select teeth for dentures.
Objectives This aim of this research is to investigate the effectiveness of the technology. This will be undertaken using 5 questionnaire based outcome measures to be completed by patients, dentists and dental technicians.
Primary Objective The primary objective is to assess the use of Augmented Reality (AR) for tooth selection.
Secondary Objectives
The secondary objectives use structured questionnaires to determine:
- the patients' assessment of using the Augmented Reality (AR) for tooth selection.
- the clinicians' assessment of using the Augmented Reality (AR) for tooth selection
- the dental technicians assessment of using Augmented Reality (AR) for tooth selection
- the clinicians' assessment of the quality and reality of the images produced by the Augmented Reality (AR) for tooth selection
- the dentists' assessment of the quality and reality of the images produced by Augmented Reality (AR) for tooth selection
Number of Patients 30 patients will be recruited
Informed Consent Witten Informed consent will be obtained from each participant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Edentulous patients receiving new dentures at Leeds Dental Hospital
Key inclusion criteria (4 listed)
- The patient, clinician and technician have capacity to give informed consent.
- The patient who is a potential participant has no natural upper anterior teeth.
- The patient who is a potential participant has capacity to read and understand the Participant Information Sheet, and questionnaire which are printed in English.
- The patient who is a potential participant is undergoing treatment for dentures within Leeds Dental Institute or the School of Dentistry at Leeds and has no natural upper anterior teeth
Key exclusion criteria (3 listed)
- The clinical use of a wax 'occlusal record block' is not part of the treatment plan.
- The patient who is a potential participant has a visual impairment and indicates they cannot adequately assess the Augmented Reality (AR) image.
- Written consent to take part in the assessment is not simultaneously obtained from the patient, the clinician and the technician participating in the construction of the dentures.
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 |
|---|---|---|
| Augmented Reality VideoAugmented Reality selfies will place a selection of denture teeth in pictures of the participants in order to enable the selection of their preferred teeth on their new denture. | Other | – |
Primary outcome
A questionnaire to determine patients' assessment of Augmented Reality App
Time frame: Up to 18 weeks from entering the study
The patients' assessment of using the Augmented Reality (AR) for tooth selection will be analysed.
4 secondary outcomes
A questionnaire to determine clinicians assessment of Augmented Reality App
Time frame: Up to 18 weeks from entering the study
A questionnaire to determine technicians assessment of Augmented Reality App
Time frame: Up to 18 weeks from entering the study
A questionnaire to determine patients' perception of the reality of the Augmented Reality App
Time frame: Up to 18 weeks from entering the study
A questionnaire to determine dentists' perception of the reality of the Augmented Reality App
Time frame: Up to 18 weeks from entering the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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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.
A J Keeling, BDS PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mouth, Edentulous, run by University of Leeds 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 4 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 3 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A questionnaire to determine patients' assessment of Augmented Reality App (time frame: Up to 18 weeks from entering the study). 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 3 Nov 2020.