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

NCT06193720 | Completed

• 1 other identifier: XFMD126
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema; Pain; Trismus

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Arnica Montana

EXPERIMENTAL

Patients will take Arnica montana before and after surgery

Drug: Arnica montana

Control

PLACEBO COMPARATOR

Patients will take placebo pills to compare the results

Other: Placebo

Interventions

Arnica montana DRUG

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

Arnica Montana

Placebo OTHER

Patients will take placebo drug after surgeries

Control

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not symmetrically impacted third molars
• Patients with health problems

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

MeSH Terms

Conditions

Edema; Pain; Trismus

Interventions

Arnicae flos extract

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 5, 2024
• Study Start: February 3, 2022
• Primary Completion: August 20, 2023
• Study Completion: August 20, 2023
• Last Updated: January 5, 2024

Record last verified: 2023-12

Locations

LE (1)