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, there is a possibility that the blood supply to the tooth may become compromised. This, in turn, can lead to the death of the tooth as the tooth pulp is no longer being supplied with blood. Such a tooth is called a non-vital tooth. The conventional tools available to assess the nerves and blood supply to a tooth are not always reliable due to many reasons including cooperation and understanding especially children. Failure to assess how good a blood supply is to the tooth may result in tooth death, weakening it and leaving in vulnerable to removal. The laser doppler flowmetry is a machine that has been used for several years. It is non-invasive and painless and shown to be more reliable than the traditional techniques. However, the current data is based on weak evidence. The aim of this study is to assess the reliability of this machine.
Who can participate?
Children aged 8-16 with a root canal treated non-vital tooth.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (test group) have their teeth vitality assessed using laser doppler flowmetry. Those in group 2 (control) have their teeth sensibility assessed using conventional electrical and thermal (ethyl chloride) pulp tests.
What are the possible benefits and risks of participating?
There are no potential risks. The patient should not experience any pain, discomfort, distress, inconvenience or change to lifestyle. There is no direct benefit to research participants. However, the results from the study may help to benefit future patients when they have dental injuries. We are assessing the use of diagnostic tools in this study regardless of any treatment needs. Any treatment will be provided at Leeds Dental Institute as per local protocols regardless of participation 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?
May 2015 to July 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
Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The diagnostic accuracy of the laser doppler flowmetry in assessing pulp vitality of traumatised teeth in paediatric patients
Acronym
Study hypothesis
1. Alternative hypothesis: Laser doppler flowmetry is more accurate than conventional method in assessing pulpal status of permanent anterior teeth in paediatric patients.
2. Null hypothesis: Laser doppler flowmetry is as accurate as the conventional method in assessing pulpal status of permenant anterior teeth in paediatric patients
Ethics approval
RES Committee North West - Greater Manchester East, 08/09/2015, ref: 15/NW/0583
Study design
Parallel-randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
The validation and assessment of the accuracy of laser doppler flowmetry in comparison to conventional pulp sensibility tests (electrical pulp test and ethyl chloride) in assessing pulpal vitality of permanent anterior traumatised teeth in paediatric patients.
Intervention
A parallel-randomised controlled diagnostic trial will be performed. This will involve two groups of patients:
1. Test group where teeth vitality will be assessed using laser doppler flowmetry.
2. Control group where teeth sensibility will be assessed using conventional electrical and thermal (ethyl chloride) pulp tests.
Intervention type
Device
Phase
Drug names
Primary outcome measures
1 The sensitivity and specificity of laser Doppler flowmetry, electrical pulp test and ethyl chloride. The number of true positives, false positives, true negatives and false negatives will be calculated for Laser Doppler flowmetry, EPT and Ethyl chloride using the traditional 2X2 table. Based on this, the sensitivity and specificity will be calculated after all the data has been collected.
2. The correct flux threshold below which a tooth could be identified as non vital when using laser Doppler flowmetry. The machine learning technique will be used to obtain the optimal threshold to distinguish vital and non-vital tooth using 50% of the data as training data, and the rest 50% will be used as test data to obtain the sensitivity and specificity of laser Doppler flowmetry
Secondary outcome measures
The repeatability and reproducibility of each method. Inter class correlation will be used to measure the repeatability and reliability of all tests.
Overall trial start date
01/05/2015
Overall trial end date
30/07/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children between 8-16 years old.
2. Medically fit (ASA I, II).
3. Understanding of English.
4. Acceptable level of cooperation.
5. Patients able to understand instructions.
6. Children with one non-vital maxillary central or lateral incisor that had a completed root canal treatment with Gutta-Percha and an ideally a contra-lateral non-traumatised vital tooth.
7. The root canal treated tooth should not be tender to percussion and have a periapical radiolucency or a sinus tract.
8. The vital tooth should ideally not have received a dental trauma however should that be the case, the tooth should:
8.1. Have received no severe luxation injuries such as intrusion, lateral luxation, avulsion, or extrusive luxation.
8.2. Have been consistently responsive to EPT and ethyl chloride pulp tests during the past 6 months.
8.3. Should have normal colour.
8.4. Should not be tender to percussion.
8.5. Not show any radiographic signs of loss of vitality
9. All teeth should be minimally restored, covering less than half the labial crown surface.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
74
Participant exclusion criteria
1. Medically and mentally compromised children
2. Children with learning disabilities
3. History of moderate and significant behaviour management problems
4. Communication barrier such as not understanding English language
5. Heavily restored teeth covering more than half the labial surface of teeth
6. Patients on routine analgesics, antidepressants or antihypertensive drugs
7. Non-vital teeth treated with regenerative endodontic technique
8. Vital teeth with pulp canal obliteration
9. If the contra lateral vital tooth:
9.1. Had severe luxation injuries such as intrusion, lateral luxation, avulsion, or extrusive luxation
9.2. Has not been consistently responsive to EPT and ethyl chloride pulp tests during the past 6 months
9.3. Is of an abnormal colour
9.4. Is tender to percussion
9.5. Shows any radiographic signs of loss of vitality
Recruitment start date
01/05/2015
Recruitment end date
30/07/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
Sponsor information
Organisation
University of Leeds, Leeds Dental Institute
Sponsor details
Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom
+44 (0)113 3434897
governance-ethics@leeds.ac.uk
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 trialists plan to disseminate the results of this study through peer reviewed journals and conference presentations as well as a PhD thesis.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary