Effectiveness of topical application of Trachyspermum Ammi (ajwain) oil in pain control during local anesthesia administration in pediatric dental patients: A randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- A sample size of 52 (26 per group) would yield 80% power to detect significant
研究概览
简要总结
A total of 52 children of age from 6-10 years, who met the inclusion criteria, will be assigned into 2 groups: Group 1 (study group) and Group 2 (control group), Group 1 will comprise of topical application of T. ammi oil before administering local anaesthesia and Group 2 will comprise of topical application of local anaesthesia spray before administering local anaesthesia.
The T. ammi oil used in this study is 100% food grade essential oil readily available in the market, This concentrated oil is diluted in ethyl alcohol for topical application. This process will take place in College of Pharmacy, Teerthanker Mahaveer University, Moradabad, The prepared oil will be stored in a black glass bottle, The oil will be freshly prepared daily for usage until the desired sample is achieved, The child and parent are explained about the procedure and pain rating scales, Tell show do technique for behaviour management, In group 1 T. ammi oil will be applied topically to the determined site using a cotton applicator, In group 2 only topical anaesthetic spray will be applied to the mucosa at the site of injection, Local anaesthesia will be administered in the respective nerve within 5min, The injection will be performed slowly, preceded by aspiration to prevent intravascular adverse effect, The pain perception during injection will be recorded immediately after the procedure using pain rating scales i.e. VAS and WB-F Pain Rating Scale and biologic parameters, Thus the values obtained will be subjected to statistical analysis.
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
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient requiring local anaesthesia (block) in either maxilla or mandible for dental procedures.
排除标准
- •Children suffering from any systemic disease, Patients with Aichmophobia, Patient with history of abscess, redness and fistula at the injection site, Children who refuse to participate in the study.
结局指标
主要结局
A sample size of 52 (26 per group) would yield 80% power to detect significant
时间窗: after 5 minutes and 30 minutes after topical application.
differences, with assuming the effect size of 0.8 and significance level at 0.05
时间窗: after 5 minutes and 30 minutes after topical application.
次要结局
- suggested oil may not be as effective as traditional spray(after 5 minutes & 30 minutes after topical application)
研究者
Dr Aatya Takuli
teerthanker mahaveer dental college and research centre