Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Orthodontic pain measurement by marking 100 millimeters visual analogue scales.
研究概览
简要总结
The purpose of this study is to compare the efficacy of ibuprofen, acetaminophen, chewing gum in reducing orthodontic pain. This study include 81 patients to be classified into 4 groups of 19 each: ibuprofen (400 mg), acetaminophen (500 mg), chewing gum and control. The patients in each group will receive 1 method immediately after placement of the initial archwire and every 6 hours for a week if they experiences pain. Pain perception will be recorded by the patients while jaw rest position and fitting back teeth at 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement, using a visual analog scale.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate teeth crowding
- •no need for tooth extraction to orthodontic reasons
排除标准
- •presence of autoimmune diseases
- •history of orthodontic treatment with fixed appliances
研究组 & 干预措施
ibuprofen
ibuprofen (400 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.
干预措施: Ibuprofen (Drug)
acetaminophen
acetaminophen (500 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.
干预措施: Acetaminophen (Drug)
chewing gum
chewing gum (01 tablet) immediately after insertion of the initial archwire and 6/6 hs of chewing gum for a week if there is any orthodontic pain.
干预措施: Chewing gum (Other)
结局指标
主要结局
Orthodontic pain measurement by marking 100 millimeters visual analogue scales.
时间窗: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
to compare the efficacy of ibuprofen, acetaminophen and chewing gum in changing orthodontic pain by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and end to the right (exacerbated pain) at different time points.
次要结局
- Chewing gum as a non pharmacologic alternative for orthodontic pain control by marking 100 millimeters visual analogue scales.(2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.)
- Pain at rest X fitting back teeth by marking 100 millimeters visual analogue scales.(2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.)
研究者
Diego Junior da Silva Santos, DDS,MsD
Principal Investigator
Rio de Janeiro State University