Evaluation of Efficacy of Calcium Hydroxide and Simvastatin as Intracanal Medicament Using ATP Bioluminescence Meter: A Randomized Clinical Trial.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of ATP levels(microbial load level) after root canal instrumentation and after removal of simvastatin and calcium hydroxide
研究概览
简要总结
Primary purpose of the study: To evaluate the microbial levels(ATP levels) after root canal instrumentation and after removal of simvastatin and calcium hydroxide intracanal medicament.
Hypothesis: To evaluate the microbial levels after root canal instrumentation and after removal of simvastatin and calcium hydroxide intracanal medicament.
Null hypothesis:
There is no significant difference in ATP levels before and after calcium hydroxide intracanal medicament.There is no significant difference in ATP levels before and after simvastatin intracanal medicament.There is no significant difference in ATP levels betweencalcium hydroxide and simvastatin as intracanal medicament.
Alternative hypothesis:
There is significant difference in ATP levels before and after calcium hydroxide intracanal medicament.There is significant difference in ATP levels before and after simvastatin intracanal medicament.There is significant difference in ATP levels between calcium hydroxide and simvastatin as intracanal medicament.
Study design: 100 patients diagnosed with pulp necrosis with symptomatic apical periodontitis will be recruited from outpatient. After randomization, patients will be treated with either simvastatin and calcium hydroxide intracanal medicament. After removal of simvastatin and calcium hydroxide intracanal medicament, 100ul liquid collected in syringe will be used for testing ATP levels using Bioluminescence meter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with pulp necrosis and symptomatic apical periodontitis Patients diagnosed with pulp necrosis and chronic apical abscess Patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis Patients diagnosed with pulp necrosis and acute apical abscess.
排除标准
- •patients diagnosed with absence of pain patients who are not willing to participate in the study patients diagnosed with root fractures.
结局指标
主要结局
Evaluation of ATP levels(microbial load level) after root canal instrumentation and after removal of simvastatin and calcium hydroxide
时间窗: Evaluation of ATP levels (indicative of microbial load) after root canal instrumentation at 45 minutes and following the removal of simvastatin and calcium hydroxide after one week.
次要结局
- post operative pain evaluation after placement of simvastatin and calcium hydroxide and after their removal(post operative pain evaluation after placement of simvastatin and calcium hydroxide at 8hrs,24hrs,48hrs,72hrs and after their removal at 7 days)
研究者
Sagala Tejaswini
Sibar institute of dental sciences