NCT03738189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

October 9, 2018

Last Update Submit

November 2, 2020

Conditions

Keywords

Dental Prosthesis DesignsDenturesDenture DesignDenture, Complete, UpperTechnology, DentalAesthetics, Dental

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • A questionnaire to determine clinicians assessment of Augmented Reality App

    Up to 18 weeks from entering the study

  • A questionnaire to determine technicians assessment of Augmented Reality App

    Up to 18 weeks from entering the study

  • A questionnaire to determine patients' perception of the reality of the Augmented Reality App

    Up to 18 weeks from entering the study

  • A questionnaire to determine dentists' perception of the reality of the Augmented Reality App

    Up to 18 weeks from entering the study

Interventions

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Edentulous patients receiving new dentures at Leeds Dental Hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Dental Institute

Leeds, West Yorkshire, LS2 9LU, United Kingdom

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • A J Keeling, BDS PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

October 9, 2018

First Posted

November 13, 2018

Study Start

September 10, 2018

Primary Completion

December 31, 2019

Study Completion

February 14, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations