Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain

NCT03944629 | Completed Results

• 1 other identifier: 12692
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Arnica; Third Molar Extraction

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Baseline and Day 5

Secondary Outcomes (2)

• 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

Study Arms (2)

Study Group

EXPERIMENTAL

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

Drug: SinEcch

Control Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

SinEcch DRUG

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

Also known as: Arnica montana

Study Group

Placebo OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

Arnicae flos extract

Results Point of Contact

• Title: Principal Investigatort
• Organization: Tufts University School of Dental Medicine

dentalresearchadministration@tufts.edu

(617) 636-6515

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: May 9, 2019
• Study Start: January 26, 2018
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Locations

US (1)