Pulpotomy or root canal treatment for the management of irreversible pulpitis in mature teeth Oral Health
Conditions
Interventions
We will recruit 274 NHS adult dental patients who have irreversible damage of the nerve in a suitable tooth who agree to take part. They will receive one of the two treatments (Root Canal
Treatment or
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Adults (16 years and older) with symptoms indicative of irreversible pulpitis (as defined by the European Society of Endodontology) in a premolar or molar tooth with deep caries and or a deep restoration.
Exclusion criteria
Exclusion criteria: 1. Tooth with immature roots, clinical or radiographic signs of a necrotic pulp, or a poor prognosis (e.g., internal or external resorption) 2. Presence of a sinus, tenderness to percussion, buccal tenderness, pathological mobility or evidence of pathology on a periapical radiograph 3. Insufficient tooth tissue for a restoration 4. All treatment delivered under a private contract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical success of Full Pulpotomy with Root Canal Treatment (no re-intervention or symptoms of pulpitis or apical periodontitis) at 1 year. Assessed using radiograph at 1-year post-randomisation: Success is the absence of apical radiolucency in the periapical radiograph following participant’s initial intervention 2. Pain is measured using the 10-point visual analogue score (VAS) at baseline, 7 days and 12 months 3. Oral Health Related Quality of Life will be assessed at 7 days and 1 year using the Oral Health Impact Profile 14 (OHIP-14) 4. Health status will be assessed using the generic EQ5D at 7 days and 1 year, consisting of five dimensions of HRQoL 5. Dental anxiety will be assessed using the validated MDAS criteria at 1 year 6. Patient Satisfaction will be assessed using the NHS England Commissioning of Dental Services Guidelines Patient Reported Experience Measures (PREMs) at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiographic success (absence of radiolucency in participant’s initial intervention) 2. Patient health related quality of life (OHIP-14) at 1 year 3. Dental pain (10-point visual analogue score (VAS)) at 1 year 4. Dental anxiety (assessed using the validated MDAS criteria) at 1 year 5. Satisfaction with care/treatment and adverse events at 1 year in 12-month questionnaire and 12 month follow up CRF 6. Patient health related quality of life and dental pain at 7 days measured using VAS and OHIP-14 in 7-day questionnaire 7. General population preferences for treatment and outcomes and predict uptake, NHS and patient perspective costs; incremental net benefit over the study follow up; and incremental cost per QALY over the 1-year follow-up and extrapolated over a modelled lifetime horizon, measured using the 12-month questionnaire, follow up CRF at 12-months and participant interviews. 8. To explore the implementation of technologies and the mechanisms of impact including acceptability of interventions to patients and clinicians by interviews at 1 year | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactLorna Macpherson
Outcome results
None listed