ISRCTN12547356CompletedNot Applicable
The diagnostic accuracy of the laser doppler flowmetry in assessing pulp vitality of traumatised teeth in paediatric patients
niversity of Leeds, Leeds Dental Institute0 sites74 target enrollmentStarted: June 15, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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