CTRI/2020/12/029561已完成不适用
Evaluation of the effect of topical anaesthesia and a modified infiltration technique on pain during injection- A double blind clinical trial
Dr Arunajatesan Subbiya MDS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Degree of pain during injection in a scale of 0 to 10
研究概览
简要总结
The aim of the study is to assess and compare the pain during infiltration by a modified two-stage local anaesthetic (LA) infiltration technique under topical anesthesia (TA). Depending upon the infiltration technique, TA and the time gap between TA and infiltration, the patients will be randomly divided into 4 groups. LA will be administered by infiltration at the mucobuccal fold of the maxillary central incisor and the pain perceived during the infiltration in each group will be recorded. The volunteers will be recalled after 24 hrs to assess the tenderness at the injection site.The results will be statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy human volunteers -Adult males / females Age : 25 to 40 yrs Sex : Male and female No systemic disease No use of analgesics, sedatives, or anti-anxiety medications for at least 2 weeks before the study Presence of an intact or minimally restored maxillary central incisor No tenderness to percussion and palpation.
- •The diagnosis of a clinically normal pulp confirmed by the electric pulp test.
排除标准
- •Pregnancy Presence of systemic disease, medically compromised patients Presence of sensitivity to lidocaine or dibucaine Presence of deep carious lesion involving pulp of maxillary central incisor Tenderness to percussion and palpation present.
结局指标
主要结局
Degree of pain during injection in a scale of 0 to 10
时间窗: 1-immediate | 2-after 24 hrs
次要结局
- Degree of pain after 24 hrs of injection in a scale of 0to10(24hrs)
研究者
研究点 (1)
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