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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06193720
• Other study ID #: XFMD126
• Status: Completed
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: August 20, 2023

Study information

• Verified date: December 2023
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 20, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Pain
• Trismus

Intervention

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

Other:
• Placebo
Patients will take placebo drug after surgeries

Locations

Country	Name	City	State
Lebanon	Saint Joseph University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	at 0,1,2,3,4,5,6,7 days after surgery
Primary	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	at 0,2,7 days after surgery
Primary	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	at 0,2 and 7 days after surgery