Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain of Initial Orthodontic Wire Insertion: a Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- Change in visual analogue score (VAS) over time
研究概览
简要总结
The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.
详细描述
Orthodontic pain is often reported for the first 4 days after the appliances are attached. This study will investigate two modes of pain management versus a placebo. Consented subjects will be randomly assigned to one of 3 groups: Group A, a combined and simultaneous therapy of 200 mg ibuprofen and 650 mg acetaminophen (3 pills total) taken orally at set time intervals (0 h, 6 h, 12 h, and 24h, 48h, 72h, and 96h); Group B, ibuprofen alone (200 mg) taken orally at same time intervals (1 ibuprofen and 2 placebo pills); Group C, placebo taken orally at the same time intervals (3 placebo pills).
The study will be blinded for the investigators, patients, and statisticians.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Ibuprofen, acetaminophen and placebo tablets have been prepared to look identical by a pharmacy. The appropriate tablets are placed in a blister pack to be delivered to the study participant. The number of tablets are the same for each blister in all blister packs.
The study participant, care provider, investigators and the outcomes assessor are all blinded to the groups.
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch);
- •extractions, if required, performed at least 2 weeks before appliance and archwire placement;
- •healthy with no significant medical findings;
- •no prophylactic antibiotic coverage required;
- •currently not taking antibiotics or analgesics;
- •no contraindications to the use of acetaminophen or ibuprofen; and
- •minimum age of 12 years
排除标准
- •Under the age of 12 or over the age of 80,
- •prisoners,
- •pregnant women,
- •decisionally challenged individuals,
- •allergy to either medication,
- •history of kidney disease,
- •liver damage or disease,
- •alcoholism/use of 3 or more alcoholic drinks during study period,
- •use of blood thinners,
- •stomach ulcers or
- •stomach bleeding.
研究组 & 干预措施
Ibuprofen and acetaminophen
one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen
干预措施: Ibuprofen 200 mg and acetaminphen 650 mg (Drug)
Placebo
3 tablets of tableting compounds with no active ingredients
干预措施: Placebo oral tablet (Drug)
Ibuprofen
one 200 mg tablet of ibuprofen and 2 placebo tablets
干预措施: Ibuprofen 200 mg (Drug)
结局指标
主要结局
Change in visual analogue score (VAS) over time
时间窗: 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances
Primary outcomes with be the pain values recorded by subjects when chewing on the 100-mm VAS at set times.The VAS line for each time period will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right.
次要结局
- Dosing Compliance(to be recorded at 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances.)