NCT03472456

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2019

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

Same day

First QC Date

February 12, 2018

Last Update Submit

September 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain evolution (decrease or increase the intensity of the pain)

    Evolution of pain (using a score of 0 to 10)

    7 days

Study Arms (2)

Articaïne

Drug: 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

Interventions

Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne

Articaïne

Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol

Eugénol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

PulpitisToothache

Interventions

Compliance

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElasticityMechanical PhenomenaPhysical Phenomena

Study Officials

  • Damien OFFNER

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

March 21, 2018

Study Start

March 22, 2018

Primary Completion

March 22, 2018

Study Completion

October 24, 2019

Last Updated

September 17, 2020

Record last verified: 2020-09

Locations