EdemaNCT06193720
The Impact of Arnica Montana Following the Surgical Extraction of Impacted Third Molars
A study testing Arnica montana in people with Edema and Pain, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Arnica montana
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteLebanon
- Study dates
- 3 Feb 2022to 20 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Symmetrically impacted bilateral third molars (mandibular or maxillary).
- Young patients aged between 16 and 40 years old.
- No consumption of tobacco or coffee.
- Consent to the terms and conditions of the study.
- Good oral hygiene.
- ASA 1.
Who cannot join
- Not symmetrically impacted third molars
- Patients with health problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Arnica Montana on Postoperative Pain, Swelling and Trismus Following the Surgical Extraction of Impacted Third Molars: A Split Mouth Randomized Clinical Double Blinded Trial
Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth.
Materials and Methods: The study is a double-blinded clinical trial recruiting patients undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars (right and left side). Patients receive alternately and randomly the verum (Arnica Montana 12 CH) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7 days postoperatively. Clinical parameters are collected and include: pain score, maximum mouth opening and facial measurements to assess edema's intensity.
- Being tested
- Arnica montana, Placebo
- Medical subject headings
- Edema, Pain, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arnica montanaDrug
Assess the effect of arnica montana on pain, swelling ans trismus after impacted third molar surgery
PlaceboOther
Patients will take placebo drug after surgeries
| Study group | Role | What they receive |
|---|---|---|
| Arnica Montana | Experimental | Patients will take Arnica montana before and after surgery Receives: Drug: Arnica montana |
| Control | Placebo comparator | Patients will take placebo pills to compare the results Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VSA
Assessment of pain on visual analogue scale (between 0 and 10, 0 being no pain at all and 10 being the worst pain)
Measured: at 0,1,2,3,4,5,6,7 days after surgery
Amount of face Swelling
Assessment of swelling after the intervention using a flexible ruler to measure the distance between fixed fixed reference points marked on the face:
- G: Mandibular angle
- C: External canthus
- T: Tragus
- S: Sub-nasal point
- P: Pogonion
Measured: at 0,2,7 days after surgery
Trismus intensity
Assessment of limitation of mouth opening after intervention between the incisal edges of the maxillary and the mandibular central incisors using a vernier caliper
Measured: at 0,2 and 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start3 Feb 2022
- Primary completion20 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Makary, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193720
- Sponsor's protocol ID
- XFMD126
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Arnica Montana on Postoperative Pain, Swelling and Trismus Following the Surgical Extraction of Impacted Third Molars: A Split Mouth Randomized Clinical Double Blinded Trial
- ClinicalTrials.gov ID
- NCT06193720
- Acronym / sponsor ID
- XFMD126
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth.
Materials and Methods: The study is a double-blinded clinical trial recruiting patients undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars (right and left side). Patients receive alternately and randomly the verum (Arnica Montana 12 CH) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7 days postoperatively. Clinical parameters are collected and include: pain score, maximum mouth opening and facial measurements to assess edema's intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arnica Montana | Experimental | Drug: Arnica montanaPatients will take Arnica montana before and after surgery |
| Control | Placebo comparator | Other: PlaceboPatients will take placebo pills to compare the results |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Symmetrically impacted bilateral third molars (mandibular or maxillary).
- Young patients aged between 16 and 40 years old.
- No consumption of tobacco or coffee.
- Consent to the terms and conditions of the study.
- Good oral hygiene.
Key exclusion criteria (2 listed)
- Not symmetrically impacted third molars
- Patients with health problems
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 |
|---|---|---|
| Arnica montanaAssess the effect of arnica montana on pain, swelling ans trismus after impacted third molar surgery | Drug | Arnica Montana |
| PlaceboPatients will take placebo drug after surgeries | Other | Control |
Primary outcome
Pain VSA
Time frame: at 0,1,2,3,4,5,6,7 days after surgery
Assessment of pain on visual analogue scale (between 0 and 10, 0 being no pain at all and 10 being the worst pain)
Amount of face Swelling
Time frame: at 0,2,7 days after surgery
Assessment of swelling after the intervention using a flexible ruler to measure the distance between fixed fixed reference points marked on the face: * G: Mandibular angle * C: External canthus * T: Tragus * S: Sub-nasal point * P: Pogonion
Trismus intensity
Time frame: at 0,2 and 7 days after surgery
Assessment of limitation of mouth opening after intervention between the incisal edges of the maxillary and the mandibular central incisors using a vernier caliper
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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 Arnica montana in people with Edema and Pain, run by Saint-Joseph University at 1 site in Lebanon.
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 2 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 5 Jan 2024. 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 Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain VSA (time frame: at 0,1,2,3,4,5,6,7 days after surgery). 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 5 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.