A Randomised Clinical Trial of Advice Regarding Acupressure or NSAIDs for the Control of Orthodontic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pain experience
研究概览
简要总结
To compare the analgesic property of acupressure with NSAIDs (Ibuprofen) in controlling pain following orthodontic treatment. This will be achieved by assessing the effectiveness of acupressure in controlling pain and discomfort by measuring the degree of pain relief after bonding of brackets to teeth and placement of initial archwire.
详细描述
Single centred randomised controlled trial with subjects recruited from a hospital orthodontic outpatient department in Dundee Dental Hospital.
If informed consent is obtained, then the subject details will be delivered to the trial coordinator for randomisation to one of the groups, NSAIDs or acupressure group.
All subjects who are eligible for inclusion will be advised of the nature and purpose of the trial. The total number of subjects recruited will be approximately 36 with the acupressure and NSAID group containing approximately 18 subjects each.
All subjects who meet the inclusion criteria will be informed of the study and written consent sought for their participation. Subjects will be recruited from the new patient clinics and routine treatment waiting list. .
The subjects will be asked to measure the level and duration of pain and discomfort using a pain diary to record their experiences using visual analogue scales (VAS). The pain diary will be completed from 4 hours to 7 days after treatment after the insertion of the first orthodontic aligning archwire.
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
- Single (Outcomes Assessor)
盲法说明
Not possible to mask due to nature of intervention except for outcome assessor
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 12-25
- •malocclusion requiring treatment
- •scheduled to begin orthodontic treatment
- •requires fixed orthodontic braces on upper and lower teeth.
排除标准
- •previous orthodontic treatment
- •current use of analgesics
- •contraindications to the use of NSAIDs
- •previous acupressure experience
研究组 & 干预措施
Advice on acupressure
Advice sheet on use of acupressure for post orthodontic pain
干预措施: Advice sheet (Behavioral)
Advice on analgesics
Advice sheet on use of NSAID analgesics for post orthodontic pain
干预措施: Advice sheet (Behavioral)
结局指标
主要结局
Pain experience
时间窗: 7 days
Visual analogue scale
次要结局
- Impact of pain on eating(7 days)
- Rescue medication(7 days)
- Impact of pain on sleep(7 days)
研究者
David Bearn
Principal Investigator
University of Dundee