Assessing the Effective Method of Pain Reduction After the Placement of Conventional Separators
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Sadaf Bashir
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain reduction
研究概览
简要总结
Rationale of study:
Separators placement is the primary step in orthodontic treatment and it is almost always accompanied by pain and discomfort which has a direct impact on the compliance and quality of life of patients. Many pharmacological methods over the past years have been recommended to ease the pain and discomfort and make orthodontic treatment more acceptable .These methods have adverse effects and hence it would be beneficial if we propose a method which will satisfy the patients and will be suitable for them to follow with minimal side effects and maximum efficacy.
Null hypothesis: lignocaine gel and chewing gum will be equally effective in reducing pain after separator placement Alternative hypothesis: lignocaine gel will be more effective than chewing gum in reducing pain after separator placement
详细描述
Data will be collected from subjects reporting to the department of orthodontics, Karachi Medical and Dental College. This study will be started after submission of the synopsis and after approval of the Ethical Review Committee.
Following the placement of separators participant will be randomly assigned in to 2 groups.It is a parallel group randamization.In this study the topical gel (lignocaine ) and a sugar free gum that is commercially available is purchased from the local market. The composition of lignocaine gel is given .Manual allocation using sealed envelope during enrolment of patient in the study. This enabled approximately equal distribution of patients from each group.
- st group: Topical gel (lignocaine gel)
- nd group: chewing gum In our study all the participant were asked to fill the questionnaire. A written informed consent was acquired from all patients for inclusion in the study.
In the topical gel group the patients were directed to apply the gel on the buccal free gingival margin of their first molar at one side when the separators are placed and reapply the gel every 8 hours . They were then requested to mark their level of pain at 2 and 8 hours and at 10 pm of the 2nd,3rd,5th and 7th day after the gel is being applied and mark it on the VAS form.
The patients in the chewing gum group were advised to chew sugar free gum for 5 minutes immediately after separators were placed and at 8 hours interval. The patients were also advised and motivated not to take any additional analgesics.
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
- None
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy with no significant medical finding
- •Currently not taking antibiotics or analgesics
- •No contraindication to the use of chewing gum/topical analgesics
- •Minimum age 12 years ,maximum age 30 years
- •Literate/English speaking
排除标准
- •Patient who did not return the completed questionnairs
- •Using analgesics or antibiotics
研究组 & 干预措施
group A
lignocaine gel every 8 hours
干预措施: lignocaine gel (Drug)
group B
chewing gum every 8 hours 5-10 mins chew
干预措施: sugar free chewing gum (Other)
结局指标
主要结局
pain reduction
时间窗: 2 hours, at 8 hours , 24 hours, at 2nd day , 3rd day , 5th and 7th day after separator placement.
Visual Analog Scale (VAS)
次要结局
未报告次要终点
研究者
Sadaf Bashir
assessing the effective method of pain reduction after the placement of conventional separators
Karachi Medical and Dental College