Self Medication in Odontology (AUDE) (AUDE)

April 5, 2024 updated by: University Hospital, Clermont-Ferrand

Self Medication and Pulpal and Periapical Dental Pain

To describe and understand the self-medication behaviours of a population of adults coming to the Clermont-Ferrand dentistry department for acute pain of pulpal origin and of a population of adults coming to the specific care unit of the Clermont-Ferrand dentistry department or the Riom hospital for treatment under general anaesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Self-medication behaviour will be studied by means of a questionnaire. Questionnaires on insecurity, anxiety about dental care, items related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF), a visual analogue pain assessment scale and the PCS-CF pain dramatisation scale will also be used.

Study Type

Observational

Enrollment (Actual)

940

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patient with acute pain of pulp origin and periapical or eligible for dental treatment under general anesthesia in a context phobic.

Description

Inclusion Criteria:

  • Adult patient, male or female, coming to consult in the Clermont-Ferrand or Riom Hospital for acute pain of pulp origin and periapical OR eligible for dental treatment under general anesthesia in a context phobic.
  • Understanding and practicing French
  • giving informed consent to participate in research.
  • Affiliation to a Social Security scheme.

Exclusion Criteria:

  • Patients under guardianship.
  • Patient's refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
acute pain of pulpal origin
no intervention
Behavioral: questionnaire
questionnaires of precarity, dental anxiety, self medication, pain
anxious group
no intervention
Behavioral: questionnaire
questionnaires of precarity, dental anxiety, self medication, pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of the self-medication behaviours
Time Frame: day 0
evaluated by patient interrogation
day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of anxiety
Time Frame: day 0
: evaluated with IDAF 4C (anxiety module between 8-40, phobia module between 5-10 and anxious situations between 10 and 50), the higher the score, the more anxious the patient is
day 0
level of insecurity
Time Frame: day 0
evaluated by questionnaire (EPICES (the patient is in situation of insecurity if the score is higher than 30))
day 0
description of the oral health with the related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF)
Time Frame: day 0
each item is evaluated with a Lickert scale
day 0
visual analogue pain assessment scale and the PCS-CF pain dramatisation scale
Time Frame: Day 0
PCS-CF scale is evaluated between 0 and 52, the higher the score, the more patient is over reacting faced with pain
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Pierre-Yves Cousson, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

May 12, 2023

Study Completion (Actual)

May 12, 2023

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2021 COUSSON
  • 2021-A00417-34 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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