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Completed

NCT Number: NCT06193720

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

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.

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Key information

Conditions

Edema Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph University

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arnica Montana

Drug

Assess the effect of arnica montana on pain, swelling ans trismus after impacted third molar surgery

Placebo

Other

Patients will take placebo drug after surgeries

Primary outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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