Effect of Simvastatin on Success of Pulpotomy in Cariously Exposed Permanent Molars: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Clinical success
研究概览
简要总结
The study will compare the outcome of complete pulpotomy in mature permanent mandibular molars with deep carious lesions by using Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate as medicament agent
详细描述
After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure, its associated risks and benefits. Clinical diagnosis of reversible pulpitis will be established. Complete pulpotomy will be done in both groups. Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate will be used as pulpotomy agents. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1 year.
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
Double
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient willing to participate in the study.
- •Age group of 15 to 40 years
- •Mature permanent mandibular molars with reversible pulpitis (positive response on the cold test and early response as compared to the adjacent or contralateral tooth)
- •Teeth exhibiting occlusal pulp exposure from primary dental caries.
- •Absence of periapical lesions assessed by radiographic examination.
- •Tooth demonstrating no mobility or swelling and no tenderness to percussion or palpation
排除标准
- •Primary teeth.
- •Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract and furcation or apical radiolucency.
- •Immune-compromised, pregnant and patients with any systemic disorder.
- •Patients taking statin medication.
- •Failure to obtain authorization from the patient.
结局指标
主要结局
Clinical success
时间窗: Baseline to 12 months
criteria for successful clinical outcome will be absence of clinical sign and symtoms which include Absence of tenderness to percussion,tooth mobility of grade 1 or less.Absence of associated soft tissue swelling or tenderness to palpation.
次要结局
- Pain analysis(Baseline to 7 days)
- Radiographic success(Baseline to 12 months)