Condition category
Oral Health
Date applied
10/12/2014
Date assigned
15/01/2015
Last edited
30/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The study is about dental occlusion (contact between teeth) and the aim is to investigate the accuracy of a new, non-invasive ‘optical’ technique to measure the horizontal axis of the jaw (the axis the jaw rotates around, when a subject closes their mouth). This axis needs to be recorded for many dental procedures. Current (mechanical) methods are invasive, time consuming and inaccurate. A simple, accurate method would raise the standard of care through improved diagnosis, treatment planning and better fitting dental prostheses.

Who can participate?
Adult health professionals recruited via posters, group emails and announcements at the end of relevant lectures. This research is part of a PhD.

What does the study involve?
Subjects will undergo a dental examination to exclude disease. Traditional impressions will then be taken of the upper and lower teeth. These will be cast in dental stone then digitised, to create ‘virtual’ dental models. Two cameras will photograph the subjects’ front teeth. The teeth will be illuminated with a pattern projected from a digital projector (rather than a camera flash). This combination enables accurate 3D photographs to be calculated. 3D photographs are taken at two differing degrees of jaw opening (one with the teeth almost touching, and one with a 10mm gape). The axis of jaw rotation can be calculated using these photographs, and the virtual models. The accuracy of this axis will be investigated using two methods. Firstly, a 3D photograph is taken at an ‘intermediate’ jaw gape (5mm). The virtual models are rotated around the previously calculated axis, to produce an identical gape (5mm). The position of the virtual models is compared to the measured position. Secondly, the ‘intermediate’ jaw position is physically recorded, using dental bite registration paste (a fast-setting silicone paste, syringed between the teeth). This paste is removed, 3D-scanned and used to align the virtual models. This position is compared to the previously calculated position.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Leeds, UK

When is the study starting and how long is it expected to run for?
December 2014 to January 2015

Who is funding the study?
1. Faculty of Medicine and Health, University of Leeds UK
2. The research is funded by the University of Leeds, as part of a PhD.

Who is the main contact?
Andrew Keeling
a.j.keeling@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Keeling

ORCID ID

Contact details

Leeds School of Dentistry
6.025 Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
+44 (0)1133431762
a.j.keeling@leeds.ac.uk

Type

Public

Additional contact

Mr Andrew Keeling

ORCID ID

Contact details

Leeds School of Dentistry
6.025 Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
0113 3431762
a.j.keeling@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

200658679

Study information

Scientific title

Accuracy of Optical Recordings of the Mandibular Horizontal Axis

Acronym

Study hypothesis

With what accuracy can an inexpensive optical method record the mandibular horizontal axis

Ethics approval

University of Leeds Dental Research Ethics Committee, 23/10/2014, ref. 200658679

Study design

Single centre - Observing and recording the jaw movements of dentate subjects using a novel optical method, and comparing this to a standard silicone bite registration method

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Dental occlusion

Intervention

Subjects will have their jaw relationships measured using standard silicone bite registration material, and using a new optical method.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The distance between reference points on upper and lower digitised teeth will be compared using the standard (silicone) method and the new (optical) method.

Secondary outcome measures

Repeatability of these measurements will be assessed.

Overall trial start date

10/07/2014

Overall trial end date

31/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Must have at least 4 upper and 4 lower anterior teeth.

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

44

Participant exclusion criteria

No pre-existing disease of the temporo-mandibular joint (jaw joint)

Recruitment start date

01/12/2014

Recruitment end date

24/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

Faculty Head of Research and Innovation Support
Faculty of Medicine and Health Research Office
Level 10
Room 10.110
Worsley Building
University of Leeds
Clarendon Way
Leeds
LS2 9NL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Faculty of Medicine and Health, University of Leeds

Alternative name(s)

FMH

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

This will form the final part of a PhD thesis, and is intended to be published in a peer reviewed journal.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes