Self MedicationAMO-CROCNCT05808452
AMO CROC Study: Self-medication and Dental Pain of Pulpal and Peri-apical Origin. Qualitative Study
An observational study of Self Medication, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Medication
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jan 2023to 17 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Adults under guardianship or curatorship
- Adults refusing to participate
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Self Medication
- Keywords
- Dental anxiety, Qualitative, Behaviors, Self Medication
- Medical subject headings
- Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
self medication behaviors description
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start30 Jan 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self MedicationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves COUSSON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808452
- Sponsor's protocol ID
- RNI 2022 COUSSON (AMO-CROC)
- Other IDs
- 2022-A01734-39
- Acronym
- AMO-CROC
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMO CROC Study: Self-medication and Dental Pain of Pulpal and Peri-apical Origin. Qualitative Study
- ClinicalTrials.gov ID
- NCT05808452
- Acronym / sponsor ID
- AMO-CROC / RNI 2022 COUSSON (AMO-CROC)
- Conditions
- Self Medication
- Keywords
- Dental anxiety, Qualitative, Behaviors, Self Medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Adults under guardianship or curatorship
- Adults refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves COUSSON principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self Medication, run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self medication behaviors description (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.