Efficacy of Chewing Sugarless Gum for Reduction of Orthodontic Fixed Appliance Activation Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pain scale reading
研究概览
简要总结
This study investigates whether chewing sugar-free chewing gum can reduce pain associated with braces treatment. The study collects pain scale records for 10 consecutive days after placement of braces. No changes to patients routine braces treatment is done. All materials used are available over the counter.
详细描述
Objectives:
- To characterize the intensity and dynamics of pain experienced by patients following orthodontic appliance placement and activation using a set of Visual Analogue pain scale diaries
- To determine whether chewing sugarless gum 3 times per day (and using a non-analgesic mouthwash) reduces orthodontic pain compared to only using a mouthwash (placebo)
Importance:
Pain from orthodontic treatment affects most if not all orthodontic patients. Learning more about the nature and timing of pain will help clinicians give patients a more scientific, evidence-based informed consent. If chewing gum was found to reduce pain, then we would have validated a common clinical advice with scientific evidence. We will also have established a non-pharmacological option for pain reduction with orthodontic treatment. If chewing gum was not found to reduce pain (or was found to increase it), then we can advise our patients against using it and advise clinicians against recommending it.
Research Methodology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fixed upper and lower orthodontic appliance therapy scheduled
排除标准
- •tooth extractions within one week
- •chronic pain
- •regular use of analgesics
- •partial appliance engagement
- •use of extra-oral appliances like headgear
- •patients unable to consume sugarless gum like phenylketonuria patients
研究组 & 干预措施
Chewing Sugarless Gum and Mouthwash
Patients are asked to chew sugarless gum 3 times per day in addition to using a fluoridated mouthwash 3 times per day
干预措施: Chewing Sugarless Gum (Other)
Chewing Sugarless Gum and Mouthwash
Patients are asked to chew sugarless gum 3 times per day in addition to using a fluoridated mouthwash 3 times per day
干预措施: Using Mouthwash (Other)
Using fluoridated mouthwash
Using Mouthwash: Patients are asked to use a fluoridated mouthwash 3 times per day as a placebo
干预措施: Using Mouthwash (Other)
结局指标
主要结局
Pain scale reading
时间窗: 10 days
Patients mark a 100mm visual analog pain scale to rate tooth pain experienced during the first 10 days of their routine orthodontic treatment
次要结局
- Patient subjective assessment of pain experience(10 days)
研究者
Athbi Alqareer
Assistant Professor
Kuwait University