Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries: A Randomized Controlled Trial Conducted in Supervised Undergraduate Clinics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
Recent clinical trials comparing pulpotomy versus root canal treatment (RCT) have shown promising outcomes; however, the current evidence lacks generalisability to general practitioners. It remains to be elucidated whether these favourable results can be replicated in a primary care setting. This study aims to address that gap by involving senior dental students undergoing supervised university education and training, with the potential to inform future best practice guidelines and promote the adoption of vital pulp therapy (VPT) as a predictable treatment alternative in the general dental population.
The clinical procedure involves complete caries-free excavation carried out under rubber dam isolation. After confirming vital pulp status-demonstrated by bleeding upon entry, participants will be randomised to receive one of two treatments: RCT or full pulpotomy.
Outcomes will include clinical and radiographic success or failure of the intervention at 12 months. Additionally, patient-reported outcomes will be collected, specifically pain experienced and the use of analgesia during the immediate post-operative period (days 3 and 7).
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
- Single (Care Provider)
盲法说明
care providers and participants are masked at the start of caries removal and up to the stage of random allocation to pulpotomy or root canal treatment.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12 years or older
- •Mature maxillary or mandibular permanent tooth with extremely deep restorations/caries penetrating the entire thickness of dentine on the radiograph without a radiopaque zone separating the lesion from the pulp (Bjorndal et al., 2019)
- •Tooth may or may not be symptomatic at the time of recruitment but must be responsive to cold and EPT sensibility testing
- •Tooth is restorable and can be adequately isolated during treatment
- •One tooth per patient
排除标准
- •Teeth with difficult access and unpredictable isolation using a rubber dam
- •Teeth aberrant root canal morphology, extreme root curvatures (>30 degrees), calcified canals/sclerosed pulp
- •Teeth indicated for elective root canal treatment for restorative purposes
- •Teeth with apical periodontitis
- •Presence of apical radiolucency
- •Any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 1.25% hypochlorite for 10 minutes
- •History of trauma to the tooth
- •Teeth with active periodontal disease (pocket depth >5mm)
- •Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
- •Patients who are pregnant or breast-feeding
- •Patients who are unable to consent
研究组 & 干预措施
Full Pulpotomy
The intra-operative standard care for pulpotomy is as follows:
- Clinical procedure should be completed over one or 2 visits
- Performed under local anaesthesia and rubber dam isolation
- Complete caries removal
- Pulp resection using sterile high-speed bur with water coolant
- Irrigation protocol with 1.25% sodium hypochlorite
- Haemostasis with a 1.25% sodium hypochlorite-moistened cotton pellet over the amputated pulps for up to 10 minutes
- Placement of Biodentine (Septodont Ltd., Saint Maur des Fausse s, France) or its alternative approved by NUCOHS for pulpotomy
- Final definitive resin-based restoration
- Post-operative periapical radiograph taken
干预措施: Full Pulpotomy (Procedure)
Root Canal Treatment
The intra-operative standard care for root canal treatment is as follows:
- Clinical procedure can be carried out over one or 2 visits
- Use of rubber dam mandatory
- Irrigation protocol with 1.25% sodium hypochlorite
- Working length with combined radiographs and apex locators
- Automated instrumentation to accompany hand instrumentation
- Preparation to apical size 2-3 larger than largest file that binds at the WL in the uninstrumented canal initial apical file (IAF)
- Canal medicament; non setting calcium hydroxide if done in two visits
- Root canal filling with gutta pecha and traditional sealers (cold lateral or warm vertical condensation)
- Ensure coronal seal
- Good quality postoperative radiograph using parallel cone technique
- Final restoration as per undergraduate clinical protocols
干预措施: root canal treatment and intracanal medicament (Procedure)
结局指标
主要结局
Primary Outcome
时间窗: 12 months
Clinical and radiographic success or failure of the intervention will be measured at 12 months. The primary outcome is a composite measure at 12 months: 1) absence of pain indicative of unhealthy pulp; 2) absence of signs and symptoms indicative of acute or chronic periapical disease; 3) absence of radiographic evidence of failure including radiolucency or resorption. Failure of any part of the composite, at or any time before 12 months, will equate to overall treatment failure.
次要结局
- Secondary Outcome(12 months)