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
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
Scientific
School of Dentistry
University of Leeds
Leeds
LS16 5RU
United Kingdom
 ORCID ID |
0000-0003-1184-6864 |
|---|
Study information
| Study design | Diagnostic cross sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Assessment of blood supply to permanent teeth in children using the laser speckle contrast imaging technique : a pilot feasibility study |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/09/2016 |
| Completion date | 01/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 01/01/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds
LS16 5RU
United Kingdom
Sponsor information
University/education
Clarendon Way
Leeds
LS2 9JT
England
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study results will be published in a peer review article. |
| IPD sharing plan |
