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. Oral Health
Conditions
Interventions
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. Con
Sponsors
University of Leeds, Leeds Dental Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The repeatability and reproducibility of each method. Inter class correlation will be used to measure the repeatability and reliability of all tests. | — |
Countries
United Kingdom
Outcome results
None listed