Clinical trial NCT03738189: Augmented Reality for Tooth Selection Augmented Reality for Tooth Selection
Official title: A Prospective Cohort Study of Augmented Reality for Tooth Selection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mouth, Edentulous
Keywords: Dental Prosthesis Designs
Dentures
Denture Design
Denture, Complete, Upper
Technology, Dental
Aesthetics, Dental
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Edentulous patients receiving new dentures at Leeds Dental Hospital

Brief 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.

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:

1. the patients' assessment of using the Augmented Reality (AR) for tooth selection.
2. the clinicians' assessment of using the Augmented Reality (AR) for tooth selection
3. the dental technicians assessment of using Augmented Reality (AR) for tooth selection
4. the clinicians' assessment of the quality and reality of the images produced by the Augmented Reality (AR) for tooth selection
5. 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.

Eligibility criteria: Inclusion Criteria:

1. The patient, clinician and technician have capacity to give informed consent.
2. The patient who is a potential participant has no natural upper anterior teeth.
3. The patient who is a potential participant has capacity to read and understand the Participant Information Sheet, and questionnaire which are printed in English.
4. 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

Exclusion Criteria:

1. The clinical use of a wax 'occlusal record block' is not part of the treatment plan.
2. The patient who is a potential participant has a visual impairment and indicates they cannot adequately assess the Augmented Reality (AR) image.
3. 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.

Primary outcomes:
measure: A questionnaire to determine patients' assessment of Augmented Reality App
timeFrame: Up to 18 weeks from entering the study
Secondary outcomes:
measure: A questionnaire to determine clinicians assessment of Augmented Reality App
timeFrame: Up to 18 weeks from entering the study
measure: A questionnaire to determine technicians assessment of Augmented Reality App
timeFrame: Up to 18 weeks from entering the study
measure: A questionnaire to determine patients' perception of the reality of the Augmented Reality App
timeFrame: Up to 18 weeks from entering the study
measure: A questionnaire to determine dentists' perception of the reality of the Augmented Reality App
timeFrame: Up to 18 weeks from entering the study
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Dental Institute
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: A J Keeling, BDS PhD
role: PRINCIPAL_INVESTIGATOR
References: