Dental AnxietyAUDENCT04949126
Self Medication in Odontology (AUDE)
An observational study of Dental Anxiety and Dental Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Anxiety, Dental Pain
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 940 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 12 May 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient with acute pain of pulp origin and periapical or eligible for dental treatment under general anesthesia in a context phobic.
Who may be able to join
- 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.
Who cannot join
- Patients under guardianship.
- Patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Anxiety, Dental Pain
- Being tested
- questionnaire
- Keywords
- Anxiety, Pulpal pain, Self medication, Observational study
- Medical subject headings
- Toothache, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
questionnaires of precarity, dental anxiety, self medication, pain
| Study group | Role | What they receive |
|---|---|---|
| acute pain of pulpal origin | no intervention Receives: Behavioral: questionnaire | |
| anxious group | no intervention Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of the self-medication behaviours
evaluated by patient interrogation
Measured: day 0
Secondary outcomes (4)
level of anxiety
: 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
Measured: day 0
level of insecurity
evaluated by questionnaire (EPICES (the patient is in situation of insecurity if the score is higher than 30))
Measured: day 0
description of the oral health with the related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF)
each item is evaluated with a Lickert scale
Measured: day 0
visual analogue pain assessment scale and the PCS-CF pain dramatisation scale
PCS-CF scale is evaluated between 0 and 52, the higher the score, the more patient is over reacting faced with pain
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start15 Jun 2021
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 940 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
- NCT04949126
- Sponsor's protocol ID
- RNI 2021 COUSSON
- Other IDs
- 2021-A00417-34
- Acronym
- AUDE
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2021
- Last updated
- 8 Apr 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 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Medication and Pulpal and Periapical Dental Pain
- ClinicalTrials.gov ID
- NCT04949126
- Acronym / sponsor ID
- AUDE / RNI 2021 COUSSON
- Conditions
- Dental Anxiety, Dental Pain
- Keywords
- Anxiety, Pulpal pain, Self medication, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 940 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 2 Jul 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute pain of pulpal origin | – | Behavioral: questionnaireno intervention |
| anxious group | – | Behavioral: questionnaireno intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with acute pain of pulp origin and periapical or eligible for dental treatment under general anesthesia in a context phobic.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients under guardianship.
- Patient's refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnaires of precarity, dental anxiety, self medication, pain | Behavioural | acute pain of pulpal origin, anxious group |
Primary outcome
description of the self-medication behaviours
Time frame: day 0
evaluated by patient interrogation
4 secondary outcomes
level of anxiety
Time frame: day 0
level of insecurity
Time frame: 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
visual analogue pain assessment scale and the PCS-CF pain dramatisation scale
Time frame: Day 0
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 8 Apr 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety and Dental Pain, run by University Hospital, Clermont-Ferrand at 1 site 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
description of the self-medication behaviours (time frame: day 0). 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 8 Apr 2024.