Augmented Reality for Tooth Selection Augmented Reality for Tooth Selection (ToothPICK)

November 2, 2020 updated by: Andrew Keeling, University of Leeds

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9LU
        • Leeds Dental Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Edentulous patients receiving new dentures at Leeds Dental Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 18 weeks from entering the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A questionnaire to determine clinicians assessment of Augmented Reality App
Time Frame: Up to 18 weeks from entering the study
The clinicians' assessment of using the Augmented Reality (AR) for tooth selection with a structured questionnaire.
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
The dental technicians assessment of using Augmented Reality (AR) for tooth selection with a structured questionnaire.
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
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
A questionnaire to determine dentists' perception of the reality of the Augmented Reality App
Time Frame: Up to 18 weeks from entering the study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Investigators

  • Principal Investigator: A J Keeling, BDS PhD, University of Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

February 14, 2020

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UoL IRAS Project ID 238446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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