Clarkson Jan E, Ramsay Craig R, Mannocci Francesco, Jarad Fadi, Albadri Sondos, Ricketts David, Tait Carol, Banerjee Avijit, Deery Chris, Boyers Dwayne, Marshman Zoe, Goulao Beatriz, Hamilton Alice R, Banister Katie, Bell Rosanne, Brown Lori, Conway David I, Donaldson Pina, Duncan Anne, Dunn Katharine, Fee Patrick, Forrest Mark, Glenny Anne-Marie, Gouick Jill, Gupta Ekta, Jacobsen Elisabet, Kettle Jennifer, MacLennan Graeme, Macpherson Lorna, McGuff Tina, Mitchell Fiona, van der Pol Marjon, Moazzez Rebecca, Roberston Douglas, Wojewodka Gabriella, Young Linda, Lamont Thomas
Dental Health Services Research Unit, Dundee Dental School, The University of Dundee, 9th Floor, Park Place, Dundee, DD1 4HN, UK.
NHS Education for Scotland, Edinburgh, UK.
Pilot Feasibility Stud. 2022 Apr 2;8(1):77. doi: 10.1186/s40814-022-01029-9.
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.
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.
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.
ISRCTN Registry, ISRCTN17973604 . Registered on 28 January 2021. Protocol version Protocol version: 1; date: 03.02.2021.
龋齿进展可导致不可逆的牙髓损伤。部分不可逆性牙髓炎是这种损伤的初始阶段，局限于冠髓，而根髓几乎没有或没有感染迹象。保持牙髓的持续活力并开发基于生物的微创治疗方法是当代临床实践的关键主题。然而，对于患有不可逆性牙髓炎的患者，除了拔牙外，根管治疗通常是唯一的选择（根管治疗需要完全去除牙髓），这给英国国家医疗服务体系（NHS）和患者带来了巨大的成本。欧洲牙髓病学会（ESE 2019）最近的共识声明推荐进行完全牙髓切断术，即切除发炎的冠髓以保持根髓活力，这是一种更微创的技术，有可能避免复杂的根管治疗。尽管这种技术可以在二级医疗机构中提供，但在英国普通牙科实践中尚未常规实施或评估。
本可行性研究旨在在初级医疗环境中确定和评估普通牙科医生的培训需求以及完全牙髓切断术干预的临床保真度，估计可能符合条件的患者群体，并在主要随机对照试验之前制定招募材料，该试验将比较完全牙髓切断术与根管治疗在16岁及以上成年人前磨牙/磨牙出现不可逆性牙髓炎迹象时的临床效果和成本效益。可行性研究将招募并培训10名初级医疗牙医掌握完全牙髓切断术技术。牙医将招募并为40名有部分不可逆性牙髓炎迹象的参与者（每个诊所4名）提供完全牙髓切断术。
成熟牙齿不可逆性牙髓炎管理的牙髓切断术（PIP）研究将解决不可逆性牙髓炎治疗中缺乏高质量证据的问题，以帮助牙科医生、患者和政策制定者进行决策。PIP可行性研究将为主要研究提供信息，即关于在普通牙科实践中提供完全牙髓切断术技术培训和实施的实用性。
国际标准随机对照试验编号注册库，ISRCTN17973604。于2021年1月28日注册。方案版本：方案版本：1；日期：2021年2月3日。
