Comparative Evaluation of Reduction in Salivary Flow Rate by using Sublingual Atropine Sulphate Drops during Dental Treatment Procedure.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Reduction in Salivary Flow Rate during Dental Treatment Procedure.
研究概览
简要总结
This study is arandomized, double blind, parallel group****clinical trialcomparing the effect of sublingual atropine sulphate drops 0.03mg/kg and Normal saline drops in reduction of salivary flow will be conducted in India. The study evaluates primary hypothesis as Are there any changes in salivary flow in the patients with normal salivary flow during dental procedures.
The primary outcome will compare and evaluate the decrease in salivary flow at baseline , 60 minutes and 90 minutes. The secondary outcome willmeasure the heart rate , systolic and diastolic blood pressure at baseline ,60 minutes and 90 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients without any systemic conditions.
- •All participants will be at least 18 years old, if a female non-pregnant and non-breastfeeding, and normotensive with no signs of heart disease.
排除标准
- •Patients with any systemic conditions patients with allergy to atropine patients with known kidney or liver impairment,anemic, treated with an anticholinergic medication.
结局指标
主要结局
Reduction in Salivary Flow Rate during Dental Treatment Procedure.
时间窗: measurement of salivary flow at baseline,60 minutes and 90 minutes.
次要结局
- change in systemic blood pressure,diastolic blood pressure and heart rate are the secondary outcomes.(time point are baseline ,60 minutes and 90 minutes.)
研究者
Dr Snehal Sunil Shinde
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College , Dhule.