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Trial record 1 of 23 for:    Eugenol
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Endodontic Medications for Irreversible Pulpitis: Articaine or Eugenol?

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ClinicalTrials.gov Identifier: NCT03472456
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Damien OFFNER 03 88 11 69 76 damien.offner@chru-strasbourg.fr

Locations
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France
Les Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Damien OFFNER    03 88 11 69 76    damien.offner@chru-strasbourg.fr   
Sub-Investigator: Anne-Marie MUSSET         
Sub-Investigator: Gabriel FERNANDEZ DE GRADO         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Damien OFFNER Les Hôpitaux Universitaires de Strasbourg

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03472456     History of Changes
Other Study ID Numbers: 6953
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
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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Eugenol
Inflammation
Pulpitis
Toothache
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Carticaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Infective Agents