The Impact of Arnica Montana Following the Surgical Extraction of Impacted Third Molars

December 20, 2023 updated by: Christian Makary, Saint-Joseph University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Saint Joseph University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Not symmetrically impacted third molars
  • Patients with health problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arnica Montana
Patients will take Arnica montana before and after surgery
Drug: Arnica montana
Assess the effect of arnica montana on pain, swelling ans trismus after impacted third molar surgery
Placebo Comparator: Control
Patients will take placebo pills to compare the results
Other: Placebo
Patients will take placebo drug after surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 0,1,2,3,4,5,6,7 days after surgery
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
at 0,2,7 days after surgery
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
at 0,2 and 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Joseph University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2022

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

August 20, 2023

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XFMD126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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