A Randomised Clinical Trial to Test the Efficacy of Selective Caries Removal (SCR) Versus Pulpotomy in Preventing Pulp Necrosis and Apical Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of teeth requiring Root Canal Treatment or Extraction
研究概览
简要总结
The study design is a randomized controlled trial and up to 120 teeth, 50 in each of the 2 groups, will be enrolled from the patients at the National University Centre for Oral Health Singapore (NUCOHS) Endodontic unit.
The primary aim of this study is to compare the efficacy of selective caries removal (SCR) and pulpotomy in preventing pulp necrosis and apical periodontitis in teeth with deep dental caries radiographically extending at least 2/3 into the width of dentine, over a review period of 6 months, 1, 3, and 5 years. The secondary aim of this study is to compare the costs (tangible i.e. restorative treatment costs, and intangible i.e. number of treatment visits and time spent at clinic to complete treatment) and tooth survival in the oral cavity, between teeth treated with SCR and pulpotomy.
详细描述
- Randomisation and Blinding Teeth will be randomised to receive either SCR or Pulpotomy blindly, with 50 teeth in each group. Teeth allocated to Pulpotomy that do not subsequently have caries extending deep to reach the pulp will be excluded from the Study. Recruitment will continue until the target sample size in each group is attained , up to a maximum of 120 teeth (surplus to account for teeth that are not able to complete the allocated treatment).
Investigators trained in SCR and Pulpotomy will perform both treatment procedures.
For patients with multiple teeth with deep carious lesions suitable for this study, the unit of randomisation will be the individual tooth and not the patient. If it is not possible to perform treatment on all the teeth in the same visit, the operator will start on the tooth which displays the deepest lesion measured radiographically and according to clinically exigencies.
In the event of emergency/unscheduled return visits due to pain, the patient's treatment notes will be made available to the attending dentist and emergency treatment rendered as appropriate (e.g. root canal treatment). This tooth and its relevant research data will be included as an event in the survival analysis but the tooth will be discontinued from the Trial. 2. Study Visits and Procedures Dental clinicians at National University Polyclinic (NUP) Dental Clinics and NUCOHS will follow a case selection template for patient referral. Timeframe for recruitment is up to 6months after referral to NUCOHS. The patients will be provided standard of care by their dentists according to the respective Institutional Practice, which may include Oral Health Education, Oral Health Instruction and/or scaling and polishing.
Consent: Patients will be informed of the Study at their first visit to NUCOHS and given time to consider participation and ask questions. Written informed consent will be obtained before proceeding to Screening.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding will be done to the outcomes assessors to reduce bias during radiographic healing assessment. Participants also will not be informed of which treatment they are undergoing.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting at National University Polyclinics (NUP) Dental Clinics or NUCOHS general dentistry clinics
- •Aged between 21-65 years old
- •Deep primary or secondary caries diagnosed on radiograph as being at least 2/3 into the thickness of dentine
- •Permanent tooth with mature apices
- •ASA I and II (American Society of Anesthesiologists Physical Status Classification System)
- •Willing to commit to dental health education (DHE), oral hygiene instructions (OHI), restoration, and reviews of treatment completed
- •Positive response to cold test with Endo-Ice® (non-lingering beyond 2 minutes) and electric pulp testing
排除标准
- •Spontaneous and/or continuous pain associated with the carious tooth
- •Pulp exposure present
- •Tooth requires a post-retained core for restoration
- •Tooth is required to support a fixed or removable partial denture
- •Tooth with localized severe periodontitis (mobility grade ≥ 2 and/or periodontal pocket ≥ 5mm)
- •Teeth with periapical lesion (defined as periapical radiolucency in connection with the apical part of the root where the width of the radiolucent lesion exceeds twice the width of the periodontal ligament space)
- •Tooth needs to be extracted
- •Tooth with occlusal trauma or occlusal overload (e.g. denture abutment tooth)
- •Tooth is unable to complete allocated treatment
- •Self-declared pregnancy
- •Patient is unable to give consent (e.g. cognitively impaired person)
结局指标
主要结局
Number of teeth requiring Root Canal Treatment or Extraction
时间窗: 6 months, 1 year, 3 years, 5 years
Efficacy of selective caries removal (SCR) and pulpotomy in preventing pulp necrosis and apical periodontitis (thus sparing patient from root canal treatment or extraction) will be measured. Pulp pathosis (defined by presence of pain, swelling, or radiographic periapical radiolucency, necessitating root canal treatment or extraction) will be recorded for teeth in each arm.
次要结局
- Tooth survival in the oral cavity(5 years)
- Number of treatment visits spent for treatment(5 years)
- Treatment time spent for treatment(5 years)
- Tooth restorative treatment costs(5 years)