Title: Pulpotomy for the management of irreversible pulpitis in mature teeth (Pulpotomy for Irreversible Pulpitis - PIP Trial)
Funder: Chief Scientist Office, Scotland

Abstract: WHAT IS THE HEALTH PROBLEM BEING ADDRESSED? _x000D_ Severe toothache can be caused by tooth decay. Tooth decay is very common; almost all adults have experienced some decay in their back teeth. Treating tooth decay costs the NHS over £3.4 billion each year. When tooth decay spreads deep into the tooth it can cause irreversible damage to the nerve of the tooth. There are different treatments available when this occurs. _x000D_ The most common treatments are root canal treatment or taking out the tooth. Root canal treatment involves removing all the nerve from within the tooth and sealing the tooth to protect it. However, it is costly for both the patient and the NHS. It can be time consuming meaning multiple trips to the dentist, as well as being technically demanding treatment. _x000D_ An alternative to a root canal treatment is to remove only the damaged part of the nerve and seal the tooth, which can be an easier and quicker treatment. This technique is called pulpotomy. _x000D_ _x000D_ WHY IS THIS STUDY NEEDED? _x000D_ Research has already been conducted in children’s teeth that supports using pulpotomy instead of root canal treatment. However, there are gaps in our knowledge about using pulpotomy in adult’s teeth, specifically in a general dental care setting, such as in a local dental practice. _x000D_ _x000D_ AIM: _x000D_ We will compare pulpotomy with root canal treatment in adult patients. We will compare several aspects of the treatments including:_x000D_ • the pain experienced by patients_x000D_ • the impact of the treatment on their lives_x000D_ • whether further treatment is needed _x000D_ • the time and financial costs incurred._x000D_ _x000D_ DESIGN: _x000D_ We have designed a study for patients who have severe tooth ache who would normally receive root canal treatment or have their tooth removed. _x000D_ We will first run a feasibility study with a small group of patients and dentists to assess the training needs of dentists for conducting pulpotomy; identify any issues around recruiting participants and delivering the treatments; and to develop patient materials for the main trial. If the feasibility stage is successful, we will progress to do a larger study. _x000D_ In the larger study, if patients are eligible and willing to take part, they will be given one of the two treatments (root canal treatment or pulpotomy) allocated at random. _x000D_ _x000D_ _x000D_ SETTING: _x000D_ The first part of our study (the feasibility stage) will recruit 10 dental practices and 40 patients. If after the feasibility study, we believe we can deliver the full study, we will recruit 50 dental practices in England and Scotland. The dentists will recruit a total of 530 NHS adult dental patients who have irreversible damage of the nerve of a tooth in adult back teeth and who agree to take part._x000D_ _x000D_ _x000D_ WHAT WILL WE MEASURE? _x000D_ We will measure how well the treatments work over one year. We will look for evidence of treatment success and compare symptoms associated with each treatment. We will measure if the tooth needs further treatment, for example a new or repeat root canal treatment or if the tooth needs to be removed. We will also measure patients’ pain and anxiety, how their oral health affects their quality of life, the costs of treatment and patient satisfaction with their dental treatment._x000D_ _x000D_ HOW WILL WE COLLECT INFORMATION? _x000D_ We will ask patients to complete questionnaire surveys to gather this information. In addition, dentists will take X-rays and provide us with other information about the two treatments. We will also interview dental staff and patients about their views on the two treatments._x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT: _x000D_ We worked with patients and members of the public to develop this study from the start. The patients we worked with were keen for us to test newer ways of treating tooth decay. They felt it was important to measure pain, tooth loss, need for and cost of treatment. A group of patient and public partners will continue to be involved as members of the study team and as external advisors. They will inform the design, conduct, interpretation and dissemination of the results of the study and are supported by a Patient and Public Involvement co-ordinator within the research team.

Lay abstract: 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._x000D_ _x000D_ Feasibility study_x000D_ 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._x000D_ _x000D_ Main trial_x000D_ Setting_x000D_ Fifty primary care dental practices in the UK._x000D_ _x000D_ Population_x000D_ Adult patients (16+ years) seeking healthcare in NHS general dental practices_x000D_ _x000D_ Inclusion criteria_x000D_ • Adults with symptoms indicative of irreversible pulpitis in a pre/molar tooth with deep caries and/or a deep restoration_x000D_ _x000D_ Exclusion criteria_x000D_ _x000D_ • Tooth with immature roots, _x000D_ • Clinical or radiographic signs of a necrotic pulp or poor prognosis _x000D_ • Insufficient tooth tissue for a restoration_x000D_ • All treatment delivered under a private contract_x000D_ _x000D_ Intervention_x000D_ FP: Removal of the inflamed coronal pulp keeping the radicular pulp vital._x000D_ _x000D_ Control_x000D_ RCTx conducted according to current practice._x000D_ _x000D_ Primary outcomes_x000D_ Clinical: Clinical success at 1 year (no re-intervention or symptoms of pulpitis or apical periodontitis)._x000D_ Economic: Incremental net benefit of FP versus RCTx over a modelled life-time horizon._x000D_ _x000D_ Secondary outcomes _x000D_ Clinical: Radiographic success (absence of radiolucency at 1 year)._x000D_ 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._x000D_ 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)._x000D_ _x000D_ Sample size_x000D_ 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._x000D_ _x000D_ Anticipated impact and dissemination_x000D_ 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.

Research activity codes: 6.4 SURGERY
Health categories: ORAL AND GASTROINTESTINAL