Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP): a feasibility study

Alice Hamilton*, Jan E. Clarkson, Craig R. Ramsay, Francesco Mannocci, Fadi Jarad, Sondos Albadri, David Ricketts, Carol Tait, Avijit Banerjee, Chris Deery, Dwayne Boyers, Zoe Marshman, Beatriz Goulao, Alice R. Hamilton, Katie Banister, Rosanne Bell, Lori Brown, David I. Conway, Pina Donaldson, Anne DuncanKatharine Dunn, Patrick Fee, Mark Forrest, Anne Marie Glenny, Jill Gouick, Ekta Gupta, Elisabet Jacobsen, Jennifer Kettle, Graeme MacLennan, Lorna Macpherson, Tina McGuff, Fiona Mitchell, Marjon van der Pol, Rebecca Moazzez, Douglas Roberston, Gabriella Wojewodka, Linda Young, Thomas Lamont

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)
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Abstract

Background: Progression of dental caries can result in irreversible pulpal damage. Partial irreversible pulpitis is the initial stage of this damage, confined to the coronal pulp whilst the radicular pulp shows little or no sign of infection. Preserving the pulp with sustained vitality and developing minimally invasive biologically based therapies are key themes within contemporary clinical practice. However, root canal treatment involving complete removal of the pulp is often the only option (other than extraction) given to patients with irreversible pulpitis, with substantial NHS and patient incurred costs. The European Society of Endodontology’s (ESE 2019) recent consensus statement recommends full pulpotomy, where the inflamed coronal pulp is removed with the goal of keeping the radicular pulp vital, as a more minimally invasive technique, potentially avoiding complex root canal treatment. Although this technique may be provided in secondary care, it has not been routinely implemented or evaluated in UK General Dental Practice. Method: This feasibility study aims to identify and assess in a primary care setting the training needs of general dental practitioners and clinical fidelity of the full pulpotomy intervention, estimate likely eligible patient pool and develop recruitment materials ahead of the main randomised controlled trial comparing the clinical and cost-effectiveness of full pulpotomy compared to root canal treatment in pre/molar teeth of adults 16 years and older showing signs indicative of irreversible pulpitis. The feasibility study will recruit and train 10 primary care dentists in the full pulpotomy technique. Dentists will recruit and provide full pulpotomy to 40 participants (four per practice) with indications of partial irreversible pulpitis. Discussion: The Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP) study will address the lack of high-quality evidence in the treatment of irreversible pulpitis, to aid dental practitioners, patients and policymakers in their decision-making. The PIP feasibility study will inform the main study on the practicality of providing both training and provision of the full pulpotomy technique in general dental practice. Trial registration: ISRCTN Registry, ISRCTN17973604. Registered on 28 January 2021. Protocol version Protocol version: 1; date: 03.02.2021

Original languageEnglish
Article number77
Number of pages11
JournalPilot and Feasibility Studies
Volume8
Early online date2 Apr 2022
DOIs
Publication statusPublished - 2 Apr 2022

Bibliographical note

Fundings:
This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Program (project reference NIHR129230). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funding body has had no role in the design of the study and will have no role in the collection, analysis, and interpretation of the data and in the writing of any future manuscript.
Acknowledgements
The authors would like to thank all the patients, dentists and dental team members who are participating in the PIP Trial. We would also like to thank the members of the TSC and DMEC.
We would like to acknowledge the funding for the project from the National Institute for Health Research Health Technology Assessment Programme (Project Number NIHR129230). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.
Sponsor: University of Dundee
Funder: National Institute for Health Research (NIHR), Health Technology Assessment (HTA) Programme, Project number: NIHR129230
The PIP study group consists of the co-chief investigators, grant holders, project management group and the Trial Management Committee as outlined as follows:
Co-chief investigators: Jan E Clarkson (JC) and Craig R Ramsay (CR)
Grant holders: Sondos Albradri (SA), Avijit Banerjee (AB), Katie Banister (KB), Dwayne Boyers (DB), David Conway (DC), Chris Deery (CD), Beatriz Goulao (BG), Ekta Gupta (EG), Fadi Jarad (FJ), Thomas Lamont (TL), Graeme MacLennan (GMacL), Francesco Mannocci (FM) Zoe Marshmann (ZM), Tina McGuff (TMcG), David Ricketts (DR), Douglas Robertson (DR) Marjon van der Pol (MvdP) and Linda Young (LY).
Trial Management Committee: Sondos Albradri (SA), Avijit Banerjee (AB), Katie Banister (KB), Chris Deery (CD), Rosanne Bell (RB), David Conway (DC), Dwayne Boyers (DB), Lori Brown (LB), Pina Donaldson (PD), Anne Duncan (AD), Katharine Dunn (KD), Patrick Fee (PF), Mark Forrest (MF), Jill Gouick (JG), Beatriz Goulao (BG), Ekta Gupta (EG), Alice Hamilton (AH), Fadi Jarad (FJ), Jennifer Kettle (JK), Thomas Lamont (TL), Graeme MacLennan (GMacL), Lorna Macpherson (LM), Francesco Mannocci (FM), Zoe Marshmann (ZM), Fiona Mitchell (FM), Tina McGuff (TMcG), David Ricketts (DR), Douglas Robertson (DR), Marjon van der Pol (MvdP), Gabriella Wojewodka (GW) and Linda Young (LY)

Keywords

  • Feasibility
  • Full pulpotomy
  • General dental practice
  • Irreversible pulpitis
  • PPI
  • Primary care
  • Root canal treatment
  • Training
  • Vital pulp therapy

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