Comparison of Acupressure, Ibuprofen, and Chewing Gum for the Management of Post-Archwire Orthodontic Pain
Comparative Efficacy of Acupressure, Ibuprofen, and Chewing Gum in Managing Post-Archwire Orthodontic Pain: A Three-Arm Randomized Clinical Trial
The goal of this clinical trial is to find out which method works best to reduce pain after braces are adjusted for the first time (when the first archwire is placed). The study will compare three approaches: acupressure (applying pressure on a specific point on the hand), ibuprofen (a pain-relief medicine), and chewing sugar-free gum. It will also check how safe these methods are and whether patients need extra pain medicine.
The main questions the researchers want to answer are:
Which method reduces orthodontic pain the most after the first archwire is placed? Do patients need extra painkillers in any of the groups? Are there any problems with braces (such as loose brackets or wire issues) within the first week?
Researchers will compare the three groups to see which option gives the best pain relief during the first few days after braces are activated.
Participants will:
Be placed into one of three groups: acupressure, ibuprofen, or chewing gum Use their assigned method after their first orthodontic wire is placed Rate their pain at different time points using a simple pain scale (VAS) Report if they take any extra pain medicine Be checked for any brace-related problems for up to 7 days
This study may help improve comfort and pain management for patients starting orthodontic treatment.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Age 15 to 35 years
- Complete permanent dentition
- Undergoing comprehensive fixed orthodontic treatment
- Scheduled for initial archwire placement
- Ability to comply with study procedures
- Written informed consent provided (or parental/guardian consent for participants younger than 18 years)
Exclusion Criteria:
- Pregnant or lactating
- Systemic disorders that may affect pain perception
- Periodontal disease
- Neurological abnormalities that may affect pain perception
- Known sensitivity to chewing gum
- Documented allergy to ibuprofen
- Use of adjunctive orthodontic appliances
- Use of analgesics, anti-inflammatory medications, or other medications that may affect pain perception within 24 hours before enrollment
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Acupressure Intervention
Participants in this arm will receive instructions on the use of acupressure for orthodontic pain management following placement of the initial archwire.
Verbal instructions and a standardized advice sheet will be provided.
Participants will be trained to apply steady, perpendicular pressure using the thumb of the opposite hand to the LI4 (Hegu) acupressure point for approximately 3 minutes.
The location of the LI4 point will be demonstrated and identified as the point on the dorsum of the hand between the first and second metacarpal bones, at the midpoint of the second metacarpal bone near its radial border.
Participants will be instructed to perform acupressure according to the standardized study protocol.
|
Participants in this arm will receive instructions on the use of acupressure for orthodontic pain management following placement of the initial archwire.
Verbal instructions and a standardized advice sheet will be provided.
Participants will be trained to apply steady, perpendicular pressure using the thumb of the opposite hand to the LI4 (Hegu) acupressure point for approximately 3 minutes.
The location of the LI4 point will be demonstrated and identified as the point on the dorsum of the hand between the first and second metacarpal bones, at the midpoint of the second metacarpal bone near its radial border.
Participants will be instructed to perform acupressure according to the standardized study protocol.
其他名称：
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有源比较器：Ibuprofen Intervention
In the ibuprofen group participants will be provided with a 400 mg oral dose post arch wire placement.
With a minimum gap of 8 hours between doses, remaining doses will be taken as per need for the relief of pain with the total daily dose not surpassing 1200 mg.
|
In the ibuprofen group participants will be provided with a 400 mg oral dose post arch wire placement.
With a minimum gap of 8 hours between doses, remaining doses will be taken as per need for the relief of pain with the total daily dose not surpassing 1200 mg.
|
|
实验性的：Chewing Gum Intervention
Instructions to chew sugar-free gum for a period of 10 minutes immediately post arch wire placement will be provided to the chewing gum group, 8 hourly, for pain relief.
|
Instructions to chew sugar-free gum for a period of 10 minutes immediately post arch wire placement will be provided to the chewing gum group, 8 hourly, for pain relief.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post-archwire orthodontic pain
大体时间：Pain levels will be recorded using a 10-cm visual analog scale (vas) at the following intervals: • 2 hours • 6 hours • Bedtime (day 1) • 24 hours (day 2) • Day 3 • Day 7
|
Pain experienced by patients following placement of the initial orthodontic archwire, measured using the Visual Analog Scale (VAS).
|
Pain levels will be recorded using a 10-cm visual analog scale (vas) at the following intervals: • 2 hours • 6 hours • Bedtime (day 1) • 24 hours (day 2) • Day 3 • Day 7
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rescue analgesic consumption
大体时间：Within 7 days following initial archwire placement.
|
Use of any additional analgesic medication beyond the assigned intervention.
|
Within 7 days following initial archwire placement.
|
|
Appliance-related complications
大体时间：Within 7 days following initial archwire placement.
|
Mechanical issues occurring such as bracket debonding or wire displacement.
|
Within 7 days following initial archwire placement.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- BUHS-IRB#264/26
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