Selective Versus Nonselective Caries Excavation in Adults: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Absence of clinical symptoms
研究概览
简要总结
Dental caries is one of the most prevalent non-communicable disease. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete nonselective excavation suggests there may be benefit for selective removal in sustaining tooth vitality while histological studies reveal that the remaining dentine is actually infected and may cause loss of vitality in long term.
The aim of this study is to randomly compare selective to non-elective excavation methods in carious mature permanent teeth with symptoms of reversible pulpitis
详细描述
The aim of this study is to randomly compare selective to nonselective excavation methods in carious mature permanent teeth with symptoms of reversible pulpitis over 4 years.
Cases will be collected from the initial treatment unit and the undergraduate clinics over a 8 months' period, the minimum sample size required is 120 teeth in 120 patients for an assumed difference of 20% in the success rate and accounting for 20% wear rate in the follow up, randomization will be performed using tabular randomization. Intensity of pulp symptoms will be recorded, patient's description of sensitivity to hot/cold/sweet lasting up to 15-20s and settling spontaneously are considered mild, while increased pain for more than several minutes and needing pain killers are considered severe.
Inclusion criteria:
- The patient age (16-60) years old
- Non -contributory medical history
- Deep caries extending>= 2/3 of dentine but not exposing the pulp on the radiograph
- The tooth should give positive response to cold testing
- Clinical diagnosis of reversible pulpitis
- The tooth is restorable, probing pocket depth and mobility are within normal limits
- No signs of pulpal necrosis including sinus tract or swelling
- No radiographic evidence of periapical changes indicative of apical periodontitis
Preoperative pulpal and periapical diagnosis will be established after clinical examination including soft tissue palpation, percussion, and cold testing (, and digital periapical and bitewing radiographs will be taken using film holders and a paralleling technique.
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
An informed consent will be obtained from the participant but he will not be informed whether selective or non selective excavation was done for him.
the outcome assessor will be blinded to the procedure, and if required masking of the crowns of teeth on radiographs will be done before evaluation.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient age (16-60) years old
- •Non -contributory medical history
- •Deep caries extending>= 2/3 of dentine but not exposing the pulp on the radiograph
- •The tooth should give positive response to cold testing
- •Clinical diagnosis of reversible pulpitis
- •The tooth is restorable, probing pocket depth and mobility are within normal limits
- •No signs of pulpal necrosis including sinus tract or swelling
- •No radiographic evidence of periapical changes indicative of apical periodontitis
排除标准
- •Immature roots
- •caries exposing the pulp on radiograph
- •symptoms of irreversible pulpits
- •In ability to control bleeding after pulp exposure
结局指标
主要结局
Absence of clinical symptoms
时间窗: 48 hours
Relief of pain after the procedure
次要结局
- Pulp vitality(6, 12, 24, 48 months)