Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain Following Third Molar Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Postoperative Facial Swelling From Baseline to Day 3
研究概览
简要总结
This study is a prospective, randomized, double-blinded, controlled, clinical trial that evaluates the efficacy of using high potency homeopathic Arnica montana (SinEcch™) during the perioperative period for decreasing swelling and pain after extraction of partial or full/complete bony impacted third molars. The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain. The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
详细描述
Our study aims to look at the efficacy of homeopathic Arnica montana (SinEcch™) in reducing postoperative edema and pain. Pain will be measured using the visual analog scale (VAS). Swelling will be measured using a 3D imaging system. This is the first study using the 3D imaging system that looks at the effect of homeopathic Arnica montana in reducing facial swelling following the surgical removal of impacted third molars. Although SinEcch is marketed mainly for management of postoperative swelling and bruising, Arnica Montana has been used for managing the sequelae of postoperative inflammation including pain so one of the secondary outcome measure for this study is to measure the efficacy of SinEcch in management of post-operative pain.
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 (Participant, Investigator)
盲法说明
To decrease bias, this study will be double blinded by blinding information about the specific group from the subject and the investigators. The study medication and matching placebo (sugar pill) will be blinded and packaged in blister cards provided by the Sponsor.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of either sex and of any race from the ages of 18 to 40 years.
- •Subjects for whom a decision has been made to extract 4 third molars, and who have at least 2 of third molar teeth classified as full or partially bony impacted in the mandible, and they will be evaluated to have at least 2 of third molar teeth classified as erupted or impacted (full or partially bony) in the maxilla under local anesthesia alone, local anesthesia and sedation, or local anesthesia and general anesthesia, all in an outpatient setting.
- •Full/complete bony: The entire tooth is below the level of the alveolar bone. The tooth is completely encased in bone so that when the gingiva is cut and reflected back, the tooth is not seen. Bone removal (large amounts) together with root sectioning will be needed to remove the tooth.
- •Partial bony: A portion of the height of the contour of the tooth is below the level of the alveolar bone. The superficial portion of the tooth is covered only by soft tissue, but the height of the tooth's contour is below the level of the surrounding alveolar bone.
- •Subjects must be physically able to tolerate conventional surgical procedures (ASA I/II).
- •Subjects must agree to follow the study protocol as shown by signing the informed consent form.
排除标准
- •Subjects who are known to be pregnant or think they may be pregnant. (A urine pregnancy test will be performed on female subjects at Day 0 - Visit
- •Subjects testing positive will be excluded from study participation.)
- •Subjects with skeletal immaturity as determined by the medical history.
- •Subjects with self-reported current or history of substance abuse.
- •Subjects who are currently receiving any anti-inflammatory or pain medication chronically, or they suffer from a chronic pain condition.
- •Subjects with an allergy to Vicodin (or its constituents, acetaminophen and hydrocodone).
- •Subjects who are diagnosed with fibromyalgia.
- •Allergy to ragweed and other related plants.
- •Subjects with an allergy to hypromellose.
- •Non-English speaking patients
研究组 & 干预措施
Study Group
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
干预措施: SinEcch (Drug)
Control Group
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
干预措施: Placebo (Other)
结局指标
主要结局
Change in Postoperative Facial Swelling From Baseline to Day 3
时间窗: Baseline and Day 3
Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system
Change in Postoperative Facial Swelling From Day 3 to Day 5
时间窗: Day 3 and Day 5
Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system
Change in Postoperative Facial Swelling From Baseline to Day 5
时间窗: Baseline and Day 5
Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system
次要结局
- Change in Post Operative Pain From Baseline to Day 3(Baseline and Day 3)
- Change in Post Operative Pain From Baseline to Day 5(Baseline and Day 5)