Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain

Tufts University53 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Arnica Third Molar Extraction

Interventions

SinEcchDRUG

The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.

PlaceboOTHER

The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. 1. 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. 2. 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. Exclusion Criteria: * 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 1. 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

Locations (1)

Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in Postoperative Facial Swelling From Baseline to Day 3

Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system

Time frame: Baseline and Day 3

Change in Postoperative Facial Swelling From Day 3 to Day 5

Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system

Time frame: Day 3 and Day 5

Change in Postoperative Facial Swelling From Baseline to Day 5

Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system

Time frame: Baseline and Day 5

Secondary Outcomes

Change in Post Operative Pain From Baseline to Day 3

Change in postoperative pain as measured by 0-100 mm Visual Analog Scale, from baseline to post-operative Day 3, and from baseline to post-operative Day 5 (0 being the least pain, 100 being the most pain)

Time frame: Baseline and Day 3

Change in Post Operative Pain From Baseline to Day 5

Time frame: Baseline and Day 5

Data from ClinicalTrials.gov

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