The use of speckle contrast imaging technique to assess pulpal blood flow

ISRCTN ISRCTN11387019
DOI https://doi.org/10.1186/ISRCTN11387019
Secondary identifying numbers V5
Submission date
11/04/2016
Registration date
25/05/2016
Last edited
18/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Nahar Ghouth
Scientific

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

ORCiD logoORCID ID 0000-0003-1184-6864

Study information

Study designDiagnostic cross sectional
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeDiagnostic
Scientific titleAssessment of blood supply to permanent teeth in children using the laser speckle contrast imaging technique : a pilot feasibility study
Study objectivesThere 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBlood supply to tooth pulp
InterventionThe blood flow of one non-vital and one vital tooth will be tested in each patient.
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureThe 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 measures1. 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 study start date01/09/2016
Completion date01/01/2017

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit16 Years
SexBoth
Target number of participants30
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2016
Date of final enrolment01/01/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Leeds Dental Institute
Clarendon Way
Leeds
LS16 5RU
United Kingdom

Sponsor information

Leeds Dental Institute
University/education

Clarendon Way
Leeds
LS2 9JT
England
United Kingdom

ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

University/education

University of Leeds
Private sector organisation / Universities (academic only)
Location
United Kingdom

Results and Publications

Intention to publish date01/01/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe study results will be published in a peer review article.
IPD sharing plan