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

Not Applicable

Completed

• Conditions: Pain; Trismus; Edema
• Interventions: Other: Placebo; Drug: Arnica montana

• Registration Number: NCT06193720
• Lead Sponsor: Saint-Joseph University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-03
• Primary Completion: 2023-08-20
• Study Completion: 2023-08-20
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Patients will take placebo pills to compare the results
Arnica Montana	Arnica montana	Patients will take Arnica montana before and after surgery

Primary Outcome Measures

Name	Time	Method
Pain VSA	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	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	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

Trial Locations

Locations (1)

Saint Joseph University; 🇱🇧 Beirut, Lebanon