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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03738189
Other study ID # UoL IRAS Project ID 238446
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2018
Est. completion date February 14, 2020

Study information

Verified date November 2020
Source University of Leeds
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date February 14, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Augmented Reality Video
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.

Locations

Country Name City State
United Kingdom Leeds Dental Institute Leeds West Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 18 weeks from entering the study
Secondary 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. Up to 18 weeks from entering the study
Secondary 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. Up to 18 weeks from entering the study
Secondary 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 Up to 18 weeks from entering the study
Secondary 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 Up to 18 weeks from entering the study
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