A tooth-saving procedure called full pulpotomy is being tested against standard root canal treatment for adults with severe toothache caused by irreversible pulpitis. This matters because root canal treatment is invasive, expensive, and often requires multiple visits. Many patients avoid or delay it, leading to tooth extraction. Full pulpotomy—removing only the inflamed pulp from the crown while keeping the living pulp in the roots—is simpler, faster, and cheaper. But it is not yet standard practice in the UK, partly because high-quality trial evidence comparing its long-term success to root canal treatment is lacking. If the trial shows full pulpotomy is non-inferior to root canal treatment, the NHS could adopt it as a first-line option for suitable teeth. That would mean fewer appointments, lower costs for the health service, and less pain and anxiety for patients. The study also tracks patient-reported outcomes like quality of life and satisfaction, ensuring the treatment works in real-world dental practices, not just in specialist clinics. The research is pragmatic and directly aimed at changing clinical guidelines and NHS policy. It is not fundamental science—it is a head-to-head comparison of two established procedures to settle which should be used when.
View original technical description
The Pulpotomy for the management of irreversible pulpitis in mature teeth Trial (Pulpotomy for Irreversible Pulpitis - PIP Trial) comprises a feasibility study to determine progression to a clinical trial (Aim 1). If progression is successful, a pragmatic, primary dental care, multi-centre, two-arm patient randomised control trial with an internal pilot will compare the clinical and cost-effectiveness of Full Pulpotomy (FP) to Root Canal Treatment (RCTx) in pre/molar teeth with symptoms indicative of irreversible pulpitis (Aim 2). A mixed-method process evaluation will complement the outcome evaluation and examine implementation issues. Feasibility study The feasibility study will involve recruitment of 10 dentists to identify training needs, and recruit up to 40 cohort patients to assess clinical and patient issues in conducting a trial. Main trial Setting Fifty primary care dental practices in the UK. Population Adult patients (16+ years) seeking healthcare in NHS general dental practices Inclusion criteria • Adults with symptoms indicative of irreversible pulpitis in a pre/molar tooth with deep caries and/or a deep restoration Exclusion criteria • Tooth with immature roots, • Clinical or radiographic signs of a necrotic pulp or poor prognosis • Insufficient tooth tissue for a restoration • All treatment delivered under a private contract Intervention FP: Removal of the inflamed coronal pulp keeping the radicular pulp vital. Control RCTx conducted according to current practice. Primary outcomes Clinical: Clinical success at 1 year (no re-intervention or symptoms of pulpitis or apical periodontitis). Economic: Incremental net benefit of FP versus RCTx over a modelled life-time horizon. Secondary outcomes Clinical: Radiographic success (absence of radiolucency at 1 year). Patient-reported: patient oral health related quality of life and dental pain at 7 days and 1 year, dental anxiety, satisfaction with care/treatment, adverse events. Economic outcomes: Use of dental care services; costs to the NHS; costs to patients; general population preferences; intervention uptake predictions; incremental net benefit; and incremental cost-per QALY gained (over trial follow-up and modelled life time horizon). Sample size The sample size is based on the non-inferiority nature of the trial and assumes 85% of RCTx’s as successful and 84% of pulpotomies. The margin of non-inferiority deemed acceptable is 12% so that P2-P1>-12%. Allowing for 30% drop-out, we aim to recruit 530 participants that will allow us to exclude -12% with 90% power for the lower bound of the 95% confidence interval. We aim to detect a mean difference of 2.7 points in the OHIP-14 score (secondary outcome), deemed to be clinically meaningful. We will have 90% power to detect a difference of this size, assuming an alpha of 0.05 and standard deviation of 8. Anticipated impact and dissemination Timely publication, updating Cochrane reviews, liaising with guideline developers, early conversations with policy makers in service and education will facilitate change to improve the adoption of the research findings.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know