ArnicaNCT03944629
Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain
A study testing SinEcch in people with Arnica and Third Molar Extraction, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Arnica, Third Molar Extraction
- What is being tested?
- SinEcch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 14 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Allergy to ragweed and other related plants.
- Subjects with an allergy to hypromellose.
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery
Boston, Massachusetts, 02111
About this study
Official title: Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain Following Third Molar Extraction
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).
Read the 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.
- Conditions
- Arnica, Third Molar Extraction
- Being tested
- SinEcch, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinEcchDrug
Also called Arnica montana
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SinEcch |
| Control Group | Placebo comparator | The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline and Day 5
Secondary outcomes (2)
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)
Measured: Baseline and Day 3
Change in Post Operative Pain From Baseline to 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)
Measured: Baseline and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start26 Jan 2018
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArnicaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944629
- Sponsor's protocol ID
- 12692
- Status last verified
- Jan 2026
- First submitted
- 15 Feb 2018
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain Following Third Molar Extraction
- ClinicalTrials.gov ID
- NCT03944629
- Acronym / sponsor ID
- 12692
- Conditions
- Arnica, Third Molar Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: SinEcchThe study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain. |
| Control Group | Placebo comparator | Other: PlaceboThe control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SinEcchAlso: Arnica montanaThe study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain. | Drug | Study Group |
| PlaceboThe control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill). | Other | Control Group |
Primary outcome
Change in Postoperative Facial Swelling From Baseline to Day 3
Time frame: 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
Time frame: 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
Time frame: Baseline and Day 5
Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system
2 secondary outcomes
Change in Post Operative Pain From Baseline to Day 3
Time frame: Baseline and Day 3
Change in Post Operative Pain From Baseline to Day 5
Time frame: Baseline and Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SinEcch in people with Arnica and Third Molar Extraction, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postoperative Facial Swelling From Baseline to Day 3 (time frame: Baseline and Day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.