Title: Managing irreversible pulpitis – The effectiveness of pulpotomy compared to root canal treatment as a replacement for conventional root canal treatment: A multicentre randomized controlled trial
Funder: Department of Health and Social Care

Abstract: Research Question: What is the effectiveness of pulpotomy as compared to root canal treatment (RoCT) Background: Caries is a chronic disease that results in the localised and progressive demineralisation (loss of mineral content) of the hard surfaces of the tooth. With continued bacterial insult, the degree of inflammation increases. Despite its original role of protection, persistent inflammation in a low-compliance environment leads to pulp necrosis and abscess (Jontell et al 1998). Irreversible pulpitis is when the pulp loses its recuperative properties and treatment to remove the diseased pulp is required. Conventional RoCT aims at complete removal of the pulp tissue and is therefore technique demanding, more time consuming and expensive costing the NHS almost &pound;51 million (Lumley, 2008). Pulpotomy may be preferred to full pulpectomy (the first stage of RoCT) in an emergency setting, with the benefit of at least 50% reduction in pain. In some regions (e.g. Liverpool), access to endodontic treatment is not equal and some patients (especially in low socio- economic groups) choose tooth extraction over RoCT. Also some dentists choose extraction for their patients as they do not feel able/competent to perform, or have no access to, endodontic services. Hence, pulpotomy may improve equity and access. High failure rates of RoCTs have been reported in literature, particularly with the use of new radiographic 3-D imaging techniques by examining the healing process of lesions following RoCT (Patel, 2012). We hypothesise pulpotomy will show substantial cost savings for the NHS and the broader public (societal level). Therefore, a randomised controlled trial (RCT) to compare the effectiveness of a less invasive, technique-sensitive, time-consuming and less costly intervention (pulpotomy) compared to the current standard of care (RoCT) is proposed. Aims and Objectives: Primary: To compare the effectiveness of pulpotomy in patients with symptoms of irreversible pulpitis compared to RoCT on the tooth pulp response; Secondary:cost-effectiveness of pulpotomy, pain relief , integrity of the restoration of the tooth, acceptability of pulpotomy as a treatment option. Methods: Trial Design: Assessor blind, multicentre 2 group (1:1) RCT (n=168) Population: Patients with irreversible pulpitis who need RoCT in secondary care settings. Intervention: Pulpotomy (Experimental) or RoCT (Control) Outcomes: Primary: Pain, tenderness or swelling at baseline and over the first 7 days post randomization using a daily diary; Secondary: The vitality or absence of apical pathology of the tooth, health resource use, EQ-5D-3L, integrity of the restoration of the tooth, health related quality of life (HRQoL) with oral health impact profile (OHIP-14) Timelines for delivery: 35 month study: Study setup 2 months, recruitment 8 months, follow up 24 months, data analyses and reporting (1 month). Trial start: 1st March 2019 . Trial Completion: 31st January 2022 Anticipated Impact and Dissemination: National (local community) and international ( randomized evidence for pulpotomy in this setting). Impact on NHS and societal costs. Dissemination at international conferences, journals and through associated PPI networks. Outputs planned: main clinical paper, cost-effectivness paper and methodological papers related to cost-effectiveness and utility measures in oral health.

Lay abstract: Aim: We aim to compare two methods of repairing and saving a badly damaged or infected tooth.One method is called root canal treatment (RoCT) and the other (new method) is called pulpotomy. Background: RoCT involves removing the damaged area of the tooth including the tooth nerve (called the pulp), cleaning, disinfecting and sealing it. Pulpotomy however attempts to preserve as much of the tooth nerve as possible (keeping the tooth alive). RoCT is more expensive and painful. Therefore, some patients delay or avoid getting treated, resulting in later complications treated in an emergency setting. This research will aim to show that pulpotomy is less painful, less involved (i.e. less invasive), less time consuming and consequently more cost effective. Long term costs of dental treatment as well as improved quality of life will therefore offer benefits for patients, public and the NHS who use dental services. Caries (tooth decay) is the most common diseases in the world. The NHS spends at least &pound;3.4 billion per year on dental visits or at dental hospitals. This does not include private (societal) costs to individuals who do not qualify for NHS dental treatment. Consequently, those who end up avoiding or delaying treatment result in complications often treated through the NHS. Methods: We have therefore chosen a randomized controlled trial design, a gold standard method to compare the effectiveness of the two treatment options. The participants will be 168 dental patients (male or female) from different parts (London and Liverpool) of the UK so that results can be generalized. A further analyses of how patients prefer and experience treatments will also be undertaken (a qualitiative analyses). Patient and Public Involvement: This design was considered in consultation with a member of the public (a co-applicant) who will be involved in the trial from the start to completion. Dissemination: The results will be published and discussed at conferences as well as through our patient and public network.

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