- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05808452
AMO CROC Study: Self-medication and Dental Pain of Pulpal and Peri-apical Origin. Qualitative Study (AMO-CROC)
January 26, 2024 updated by: University Hospital, Clermont-Ferrand
Adult patients with dental anxiety or phobia constitute a population for which access to dental care is difficult and this situation is often associated with am low socio-economic status.
According to the literature, these patients avoid conventional care, make greater use of emergency services, and self-medicate when experiencing dental pain.
Moreover, little is known in the literature about the use of self medication in France, although it is known that in the general population does self medicate a lot.
The objective of this study is to better understand the self-medication behaviors of patients in order to improve their care.
This work aim at characterizing a population of adults in need of treatment for dental pain of pulpal or periapical origin and anxious or phobic adults in need of for dental treatment under general anesthesia.
Self-medication behaviors will be studied in qualitative research during recorded interviews.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
15
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
-
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Clermont-Ferrand, France
- Chu Clermont-Ferrand
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Riom, France
- Ch de Riom
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Population included in the study will be comprised of Adults visiting the odontology unit for dental pain due to acute pulpitis Adults in need of dental treatment under general anesthesia recruitment will be done during dental consultations.
Their non opposotion to participate to the study will be
Description
Inclusion Criteria:
- Adults visiting the odontology unit for dental pain due to acute pulpitis or in need of dental treatment under general anesthesia
- Speaking French
- Able to give his/her informed consent
- Affiliated to the health social security system
Exclusion Criteria:
- Adults under guardianship or curatorship
- Adults refusing to participate
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self medication behaviors description
Time Frame: 1 year
|
Describe and understand self medication behaviors in adults visiting the odontology unit for dental pain of acute pulpal origin and in need of dental treatment under general anesthesia, via a qualitative study.
A semi-structured interview will be conducted.
Participants will be interviewed alone.
The interviews will be conducted in face-to-face in French, following this interview guide.
The data will be analyzed continuously to stop the inclusion of patients when data's saturation is reached, when no new ideas are raised.
Questions about self medication related to dentistry and anxiety of the dental environment will be asked.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 30, 2023
Primary Completion (Actual)
January 17, 2024
Study Completion (Actual)
January 17, 2024
Study Registration Dates
First Submitted
January 18, 2023
First Submitted That Met QC Criteria
March 30, 2023
First Posted (Actual)
April 11, 2023
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI 2022 COUSSON (AMO-CROC)
- 2022-A01734-39 (Other Identifier: 2022-A01734-39)
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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