Endodontic Medications for Irreversible Pulpitis: Articaine or Eugenol?

Articaine or Eugenol: a Study on the Choice of Endodontic Medication in the Emergency Management of Irreversible Pulpitis of a Mature Permanent Tooth

The objective of the study is to determine which of the two commonly used endodontic medications (Eugenol VS Articaine) is most effective in controlling postoperative pain in irreversible pulpitis of the mature permanent tooth in adults. To do so, an assessment of the pain felt by patients will be carried out a few days apart. The supposed results are that the medications are equivalent in terms of effectiveness on the pain, but could then present different economic arguments

Study Overview

• Status: Completed
• Conditions: Endodontic Inflammation; Pulpitides; Toothaches; Operative Dentistry
• Intervention / Treatment: Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne; Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol

Detailed Description

In irreversible pulpitis of the mature permanent tooth, the enrolled patients receive endodontic medications (Eugenol or Articaine) in order to determine which one is the more efficient to control the pain.

These patients would have received the same medication without this study. That's why this is an obsevationnal study.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from the University Hospital (Dental Service) of Strasbourg (HUS)

Description

Inclusion Criteria:

• Adult patient, major, affiliated to a social health insurance scheme
• Patient having agreed to participate in the study
• Urgent consultant patient for irreversible pulpitis
• Patient understanding French

Exclusion Criteria:

• Refusal of the patient to participate in the study
• Impossibility of performing the surgical procedure
• Impossibility to give the subject information enlightened (difficulty of understanding ...)
• Subject under the protection of justice, or under guardianship
• General contraindication to endodontic treatment in 2 sessions (high risk of infectious endocarditis, for example)
• Chronic intake of analgesic drugs

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Articaïne	Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne; Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne
Eugénol	Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol; Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evolution (decrease or increase the intensity of the pain)	Evolution of pain (using a score of 0 to 10)	7 days

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Damien OFFNER, Les Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Actual): March 22, 2018
• Study Completion (Actual): October 24, 2019

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Facial Pain; Inflammation; Pulpitis; Toothache; Physiological Effects of Drugs; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Carticaine; Eugenol
• Other Study ID Numbers: 6953

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