The Impact of Arnica Montana on Postoperative Pain, Swelling and Trismus Following the Surgical Extraction of Impacted Third Molars: A Split Mouth Randomized Clinical Double Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain VSA
研究概览
简要总结
Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth.
Materials and Methods: The study is a double-blinded clinical trial recruiting patients undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars (right and left side). Patients receive alternately and randomly the verum (Arnica Montana 12 CH) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7 days postoperatively. Clinical parameters are collected and include: pain score, maximum mouth opening and facial measurements to assess edema's intensity.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symmetrically impacted bilateral third molars (mandibular or maxillary).
- •Young patients aged between 16 and 40 years old.
- •No consumption of tobacco or coffee.
- •Consent to the terms and conditions of the study.
- •Good oral hygiene.
排除标准
- •Not symmetrically impacted third molars
- •Patients with health problems
研究组 & 干预措施
Arnica Montana
Patients will take Arnica montana before and after surgery
干预措施: Arnica montana (Drug)
Control
Patients will take placebo pills to compare the results
干预措施: Placebo (Other)
结局指标
主要结局
Pain VSA
时间窗: at 0,1,2,3,4,5,6,7 days after surgery
Assessment of pain on visual analogue scale (between 0 and 10, 0 being no pain at all and 10 being the worst pain)
Amount of face Swelling
时间窗: at 0,2,7 days after surgery
Assessment of swelling after the intervention using a flexible ruler to measure the distance between fixed fixed reference points marked on the face: * G: Mandibular angle * C: External canthus * T: Tragus * S: Sub-nasal point * P: Pogonion
Trismus intensity
时间窗: at 0,2 and 7 days after surgery
Assessment of limitation of mouth opening after intervention between the incisal edges of the maxillary and the mandibular central incisors using a vernier caliper
次要结局
未报告次要终点
研究者
Christian Makary
Professor
Saint-Joseph University