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
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 6
- 主要终点
- Short term pain following pulpotomy versus root canal treatment
研究概览
简要总结
The study aims 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. 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 the 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 £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. 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. 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. The results will be published and discussed at conferences as well as through our patient and public network.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Dental patients from an acute (secondary care) setting from at least three UK centres (including King's College London Dental Institute, Denmark Hill and Liverpool).
- •Male or female (aged >16) able to provide informed consent in otherwise good general health with at least one molar tooth with clinical symptoms of irreversible pulpitis caused by caries, requiring RoCT (endodontic treatment).
- •Patients enrolled will have clinical symptoms of irreversible pulpitis who need treatment.
排除标准
- •Exclusion Criteria:
- •The presence of fistulas or swelling
- •Anterior teeth or premolars
- •External or internal root resorption
- •Multiple teeth with carious lesions in the same quadrant,
- •Pregnant women, in view of requirements for radiographs.
- •Patients younger than
- •Patients unable to give consent.
- •Patients who have been administered antibiotics in the previous month.
- •Immunocompromised patients
- •Teeth with hopeless prognosis with caries extended into root dentine and with tooth margin at crestal bone level
结局指标
主要结局
Short term pain following pulpotomy versus root canal treatment
时间窗: 7 days
Pain, tenderness or swelling assessment at baseline and over the first 7 days post completion of treatment using a daily diary of pain (based on a 10 point visual analogue (VAS Scale), measured using the area under the curve (AUC) approach).
次要结局
- Cost-effectiveness of pulpotomy(2 years)
- success rates of pulpotomy compared to root canal treatment(2 years)
- sensitivity and specificity of CBCT versus periodical radiographs to detect periapical radiolucencies(2 years)
- Quality of life difference between patients that receive pulpotomy versus root canal treatment(12 months)
