Condition category
Oral Health
Date applied
11/04/2016
Date assigned
25/05/2016
Last edited
18/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Teeth injuries are considered one of the most challenging events that occur in dentistry, especially in children. After an injury, it is possible that the blood supply to the tooth may become affected and compromised leading to death of the nerves and blood vessels in the tooth, and therefore of the tooth itself. Once a tooth is dead, it is described as non-vital. The conventional diagnostic tools available to assess tooth nerve/blood supply are not always reliable. Child cooperation and understanding contribute greatly to this shortfall. Failure to assess the vitality of the tooth (that is, failure to assess whether the tooth is still alive) may result in de-vitalising a normal tooth (that is, saying a tooth is dead when it is not) which may render the tooth weak for the suturing (stitching) and possibly losing the tooth. A new non-invasive, non-patient contact, entirely safe and painless laser speckle contrast imaging technique has been developed. It is a method which visualizes tissue blood supply in the microcirculation (tiny blood vessels) instantaneously using a camera. It would be an excellent diagnostic tool for use detect the blood flow in the dental pulp. As a result, this study will look at testing this machine when used to assess the feasibility of recording blood flow in teeth.

Who can participate?
Children aged between 8-16 with one non-vital tooth and – preferably, a matching live (vital) tooth.

What does the study involve?
The blood flow of one non-vital and one vital tooth is tested in each patient using the laser speckle contrast imaging technique. The results are then used to assess the accuracy and reliability of the new machine.

What are the possible benefits and risks of participating?
There are no direct benefits or risks associated with taking part in the study.

Where is the study run from?
Leeds Dental Institute (UK)

When is the study starting and how long is it expected to run for?
September 2016 to January 2017

Who is funding the study?
University of Leeds (UK)

Who is the main contact?
Mr Nahar Ghouth

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nahar Ghouth

ORCID ID

http://orcid.org/0000-0003-1184-6864

Contact details

School of Dentistry
University of Leeds
Leeds
LS16 5RU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V5

Study information

Scientific title

Assessment of blood supply to permanent teeth in children using the laser speckle contrast imaging technique : a pilot feasibility study

Acronym

Study hypothesis

There is no significant difference between the flux values of the vital and non vital teeth when using laser speckle contrast imaging technique when assessing pulpal blood flow in children.

Ethics approval

Not provided at time of registration

Study design

Diagnostic cross sectional

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Blood supply to tooth pulp

Intervention

The blood flow of one non-vital and one vital tooth will be tested in each patient.

Intervention type

Device

Phase

Drug names

Primary outcome measures

The FLUX value for the pulpal blood flow.It will be measured for a vital tooth and non vital tooth at a single time point only.After which, a statistical ratio is calculated to get the sensitivity/specificity.

Secondary outcome measures

1. Repeatability of the machine will be calculated using FLUX values.
2. A second measurement on 20% of the sample size will be done to calculate the reliability by comparing FLUX values.

Overall trial start date

01/09/2016

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children between 8-16 years old
2. Medically fit (ASA I)
3. Children with one non-vital maxillary central or lateral incisor that had a completed root canal treatment or pulp extirpation, and an ideally a contra-lateral non-traumatised vital tooth
4. The non-vital tooth should not be tender to percussion or have periapical radiolucency or a sinus tract

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Heavily restored teeth covering more than half the labial surface of teeth
2. Non-vital teeth treated with regenerative endodontic technique
3. Vital teeth with pulp canal obliteration

Recruitment start date

01/09/2016

Recruitment end date

01/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Dental Institute
Clarendon Way
Leeds
LS16 5RU
United Kingdom

Sponsor information

Organisation

Leeds Dental Institute

Sponsor details

Clarendon Way
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Leeds

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study results will be published in a peer review article.

Intention to publish date

01/01/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes