Carious Tissue Selective Removal on Permanent Posterior Teeth. A Randomized Controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Clinical post-operative pain
研究概览
简要总结
This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of selective removal of carious tissue in deep lesions of posterior teeth. Three different materials will be used as liners (VitreBond ™Plus, BioDentine™, and Theracal™ LC). Post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.
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)
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
- •Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
- •Understands and is willing to comply with all study procedures and restrictions.
- •Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
- •Diagnosis of normal pulp or reversible pulpitis.
- •No presence of periapical periodontitis
- •Posterior teeth
排除标准
- •General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.
- •Specific: Impossibility of restoration, diagnosis of irreversible pulpitis or necrosis, preoperative pain
研究组 & 干预措施
VitreBond LC
VitreBond LC used as a liner after selective carious tissue removal.
干预措施: Carious tissue selective removal (Procedure)
Biodentine
Biodentine used as a liner after selective carious tissue removal.
干预措施: Carious tissue selective removal (Procedure)
Theracal
Theracal used as a liner after selective carious tissue removal.
干预措施: Carious tissue selective removal (Procedure)
结局指标
主要结局
Clinical post-operative pain
时间窗: 48 hours post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Radiographic signs of periapical disease
时间窗: 4 years
Absence/presence of radiographic apical periodontitis
Clinical signs or symptoms of pulp or periapical disease
时间窗: 5 years
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Clinical post-operative pain
时间窗: Immediately post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
时间窗: 8 hours post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
时间窗: 24 hours post-treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of pulp or periapical disease
时间窗: 1 year
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Clinical signs or symptoms of pulp or periapical disease
时间窗: 2 years
Absence/presence of clinical signs or symptoms of pulp or periapical disease
Radiographic signs of periapical disease
时间窗: 1 year
Absence/presence of radiographic apical periodontitis
Radiographic signs of periapical disease
时间窗: 2 years
Absence/presence of radiographic apical periodontitis
次要结局
未报告次要终点
研究者
Juan Gonzalo Olivieri
Principal investigator
Universitat Internacional de Catalunya