Arnica, Third Molar Extraction
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGSinEcch
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
OTHERPlacebo
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postoperative Facial Swelling From Baseline to Day 3 | 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 | 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 | Baseline and Day 5 | Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post Operative Pain From Baseline to Day 3 | Baseline and 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) |
| Change in Post Operative Pain From Baseline to Day 5 | Baseline and Day 5 | 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) |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants |
| Age, Continuous | 22.95 years |
| BASELINE PAIN | 0.4259 units on a scale STANDARD_DEVIATION 1.53788 |
| BASELINE Postoperative Swelling Left Side | 40.589 Cm^2 STANDARD_DEVIATION 23.28939 |
| BASELINE Postoperative Swelling Right Side | 45.9915 Cm^2 STANDARD_DEVIATION 27.64742 |
| Race/Ethnicity, Customized African American | 6 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 6 Participants |
| Race/Ethnicity, Customized Multi | 4 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants |
| Race/Ethnicity, Customized White | 11 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
None listed