A study comparing treatments for severe toothache in adult teeth: Full Pulpotomy or Root Canal Treatment
Not Applicable
- Conditions
- Pulpotomy or root canal treatment for the management of irreversible pulpitis in mature teethOral Health
- Registration Number
- ISRCTN16553016
- Lead Sponsor
- niversity of Dundee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 530
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>2. Pain is measured using the 10-point visual analogue score (VAS) at baseline, 7 days and 12 months<br>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)<br>4. Health status will be assessed using the generic EQ5D at 7 days and 1 year, consisting of five dimensions of HRQoL<br>5. Dental anxiety will be assessed using the validated MDAS criteria at 1 year<br>6. Patient Satisfaction will be assessed using the NHS England Commissioning of Dental Services Guidelines Patient Reported Experience Measures (PREMs) at 1 year
- Secondary Outcome Measures
Name Time Method