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Endodontic Medications for Irreversible Pulpitis: Articaine or Eugenol?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03472456
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Pulpitides Endodontic Inflammation Toothaches Operative Dentistry 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 Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Articaine or Eugenol: a Study on the Choice of Endodontic Medication in the Emergency Management of Irreversible Pulpitis of a Mature Permanent Tooth
Actual Study Start Date : March 22, 2018
Actual Primary Completion Date : March 22, 2018
Actual Study Completion Date : October 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pain evolution (decrease or increase the intensity of the pain) [ Time Frame: 7 days ]
    Evolution of pain (using a score of 0 to 10)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from the University Hospital (Dental Service) of Strasbourg (HUS)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472456


Locations
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France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Damien OFFNER Les Hôpitaux Universitaires de Strasbourg
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03472456    
Other Study ID Numbers: 6953
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulpitis
Toothache
Inflammation
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
 Eugenol
Carticaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Infective Agents