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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03472456
Other study ID # 6953
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2018
Est. completion date October 24, 2019

Study information

Verified date September 2020
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 24, 2019
Est. primary completion date March 22, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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
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

Locations

Country Name City State
France Les Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain evolution (decrease or increase the intensity of the pain) Evolution of pain (using a score of 0 to 10) 7 days
See also
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