Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
试验速览
- 阶段
- 4 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Leves RANK-L
研究概览
简要总结
Due to the high prevalence of malocclusions in Mexico and the existing concern to improve aesthetics, function (chewing), or both, patients resort to orthodontic treatment. The patient may experience pain during treatment due to the release of different chemical mediators such as RANK-L. Analgesic and anti-inflammatory medications such as acetaminophen and ketorolac are used to control pain during orthodontic tooth movement. These drugs can inhibit the expression of RANK-L which can affect tooth movement, inhibiting bone remodeling. The orthodontist should indicate the drug that is safest for the patient without affecting treatment or tooth movement.
详细描述
Objective
To evaluate the association of RANK-L levels with the administration of paracetamol and ketorolac in patients starting orthodontic treatment.
Material and methods
A double-blind clinical trial will be carried out with a placebo control group and random drug allocation. Patients who begin orthodontic treatment in the Orthodontic Specialty of the Comprehensive Dental Clinics of the University Center for Health Sciences and who decide to participate in the study with the signing of informed consent will be included. Three groups will be formed with 8 patients in each one.
The first group will be administered with Placebo (calcined magnesia), the second group with Ketorolac and the third group with Paracetamol, for all groups the medication will be one capsule every 6 hours for 5 days all study subjects will be sampled Gingival Crevicular Fluid (LGC), Visual Analogue Pain Scale (APS) and Intermolar Space (IS).
Measurements will be made four times; baseline, 24 h, 48 h, and on day 5 of initiation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Blinded, the orthodontist performing the clinical intervention and the investigator
入排标准
- 年龄范围
- 18 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes between 18 and 27 years of age
- •Periodontally and systematically healthy
- •Attended the Orthodontic Clinic of the University of Guadalajara
- •Who required the use of dental spacers in at least one quadrant were included
排除标准
- •Patients who have previously had orthodontic treatment or are under orthodontic treatment
- •Who have an allergy to ketorolac or paracetamol
- •Who are under pharmacological treatment and/or using contraceptives
- •Pregnant or lactating women, as well as those who consume alcohol were not included or tobacco.
研究组 & 干预措施
Placebo
Placebo (calcined magnesia) in capsules, one capsule every 8 hours for 5 days.
干预措施: Ketorolac (Drug)
Ketorolac
Ketorolac 10 mg capsules, one capsule every 8 hours (30 mg daily) for 5 days.
干预措施: Ketorolac (Drug)
Paracetamol
Paracetamol capsules of 500 mg, one capsule every 8 hours (1.5 g per day) for 5 days.
干预措施: Ketorolac (Drug)
结局指标
主要结局
Leves RANK-L
时间窗: Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Leves Gingival Crevicular Fluid of RANK-L
次要结局
- Pain scale(Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.)
- Intermolar Space (IS)(5 days of initiation of treatment.)
研究者
Juan Ramon Gomez Sandoval
principal investigator
University of Guadalajara