Dental CareURGDENTNCT03819036
Qualitative Assessment of Emergency Dental Treatments
A study testing Questionnaires in people with Dental Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of the study is to evaluate the efficiency of emergency procedures and patient satisfaction within the GHPS (Groupe Hospitalier Pitié Salpêtrière) Dental Emergency Department. Pain is the main reason of consultation at dental emergency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Care
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2019to 30 Jul 2020
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Patient reachable by telephone during the week following his / her care in the service
- Collection of the non-opposition of the patient for his participation in research
- Good understanding of the French language
Who cannot join
- Patient with communication difficulties or difficulties in understanding the French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Assessment of Emergency Dental Treatments in the Pitie Salpetriere Hospital
The objective of the study is to evaluate the efficiency of emergency procedures and patient satisfaction within the GHPS (Groupe Hospitalier Pitié Salpêtrière) Dental Emergency Department.
Pain is the main reason of consultation at dental emergency.
The investigators evaluate the pain felt before and after the intervention of the emergency with questionnaires at the day of the consultation (D0), then with phone interviews at D1, D3 and D7.
The investigators also evaluate the quality of the reception and care provided in the GHPS service using a satisfaction questionnaire completed by the patients at D0.
Read the detailed description
- Research progress
Two investigators will take turns in the service for the research duration. They will be responsible for informing patients of the research upon their arrival in the service, for the data collection and telephone follow-ups.
The course of the research will take place as follows:
Day of consultation (D0):
- Patient information on the research when he arrives in the service; explanation of its objectives, its modalities and constraints.
- Verification of eligibility criteria.
- Collection of the patient's non-opposition by the dentist during the consultation
- Consultation according to the usual care. During this procedure, the practitioner performs a medical history and, according to the patient's answers, completes the "General Information Questionnaire". He carries out the emergency care and explains the postoperative consequences.
- Patient filling in the satisfaction questionnaire immediately after consultation. Telephone follow-up (D1, D3, D7):
- Telephone follow-up by the interviewer and fill in the questionnaire - in case of non-availability of the patient on day 1, the patient will be recalled on day 2 and the extrapolated data on the slope of the curve between D1 and D2
- Telephone follow-up by the interviewer on the day and filling in the questionnaire - if the patient is not available on day 3, the patient will be recalled on day 4 and the data extrapolated according to the slope of the curve between D1 and D4; if the patient is not available at D4, he will be recalled to D5 and the extrapolated data between D1 and D5.
- Telephone follow-up on the interviewer's day and fill in the questionnaire in case of non-availability of the patient on day 7, the patient will be recalled to D8 and the data extrapolated according to the slope of the curve between D3 and D8; if the patient is still not available on D8, he will be recalled to D9 and the extrapolated data between D3 and D9.
II.STATISTICAL ASPECTS
II.1. Statistical justification for the sample size
58,921 patients were received in emergency consultation day and night during the year 2017. A sample of 1% of the population concerned will be constituted.
Patients received in day emergencies (44,191 patients in 2017) will be eligible. On average 121 patients are received daily in emergencies of day, about 600 per week (excluding weekend).
According to a previous study in the department, 50% of patients in care could not be included in the study or were lost to follow-up.
This leads to a number of 300 patients per week.
The study will therefore be conduct over 2 weeks, to include 600 patients, ie 1.3% of the population consulting
II.2. Description of statistical methods
A descriptive analysis of the characteristics of the sample will be performed (age, sex, reason for consultation, diagnosis, prior appointment test, average score of anxiety and pain scores on D0, D1, D3, D7, compliance with instructions and making follow-up appointments,), satisfaction rating, appreciation of the quality of medical care, politeness of staff, waiting time, assessment of the quality of the care setting, the information received, the treatment received, and the recommendation of the service to third parties will be made.
An analysis of the evolution of pain and anxiety scores between D0, D1, D3 and D7 will be performed.
Correlations between the type of treatment and the perceived pain as well as the type of treatment and the perceived anxiety will be made.
II.3. Method of taking into account missing or invalid data
Patients unreachable during the telephone follow-up period will be contacted the next day; the pain and anxiety scores will then be extrapolated from the previous data and the new data collected, by calculating the nearest point on the curve connecting these two data. If they are new unreachable, the data will be considered missing. Data from patients with missing data will be analyzed separately.
- Conditions
- Dental Care
- Being tested
- Questionnaires
- Keywords
- Dental emergency, Toothache, Tooth pain
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Day 0 : Satisfaction questionnaire immediately after consultation Day 1, Day 3 and Day 7 : Telephone follow-up
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Questionnaires for patients requiring dental emergencies care Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores evolution 24 hours after treatment
The pain is measured by simple digital scale (ENS).
The patient notes his pain between 0 and 10.
0 being the lowest pain, 10 being the highest pain.
Measured: Day 1
Secondary outcomes (3)
Pain scores evolution 3 days ans 7 days after treatment
The pain is measured by simple digital scale (ENS).
The patient notes his pain between 0 and 10.
0 being the lowest pain, 10 being the highest pain.
Measured: Day 3 and Day 7
Anxiety score evaluation bound to the care
Anxiety is measured by simple digital scale (ENS) from 0 to 10.
Measured: Day 0, Day 1, Day 3 and Day 7
Welcome quality evaluation from hospital staff
The reception, cleanliness quality and waiting time will be measured by ENS scale from 0 to 10.
Measured: The day of the emergency care (Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start18 Feb 2019
- Primary completion18 Jul 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CareStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves BOUCHER, PU-PH, Principal investigator, Assistance Publique Hoptiaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819036
- Sponsor's protocol ID
- APHP180366
- Other IDs
- 2018-A02692-53
- Acronym
- URGDENT
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Assessment of Emergency Dental Treatments in the Pitie Salpetriere Hospital
- ClinicalTrials.gov ID
- NCT03819036
- Acronym / sponsor ID
- URGDENT / APHP180366
- Conditions
- Dental Care
- Keywords
- Dental emergency, Toothache, Tooth pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 28 Jan 2019 (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.
The objective of the study is to evaluate the efficiency of emergency procedures and patient satisfaction within the GHPS (Groupe Hospitalier Pitié Salpêtrière) Dental Emergency Department.
Pain is the main reason of consultation at dental emergency.
The investigators evaluate the pain felt before and after the intervention of the emergency with questionnaires at the day of the consultation (D0), then with phone interviews at D1, D3 and D7.
The investigators also evaluate the quality of the reception and care provided in the GHPS service using a satisfaction questionnaire completed by the patients at D0.
Detailed description
- Research progress
Two investigators will take turns in the service for the research duration. They will be responsible for informing patients of the research upon their arrival in the service, for the data collection and telephone follow-ups.
The course of the research will take place as follows:
Day of consultation (D0):
- Patient information on the research when he arrives in the service; explanation of its objectives, its modalities and constraints.
- Verification of eligibility criteria.
- Collection of the patient's non-opposition by the dentist during the consultation
- Consultation according to the usual care. During this procedure, the practitioner performs a medical history and, according to the patient's answers, completes the "General Information Questionnaire". He carries out the emergency care and explains the postoperative consequences.
- Patient filling in the satisfaction questionnaire immediately after consultation. Telephone follow-up (D1, D3, D7):
- Telephone follow-up by the interviewer and fill in the questionnaire - in case of non-availability of the patient on day 1, the patient will be recalled on day 2 and the extrapolated data on the slope of the curve between D1 and D2
- Telephone follow-up by the interviewer on the day and filling in the questionnaire - if the patient is not available on day 3, the patient will be recalled on day 4 and the data extrapolated according to the slope of the curve between D1 and D4; if the patient is not available at D4, he will be recalled to D5 and the extrapolated data between D1 and D5.
- Telephone follow-up on the interviewer's day and fill in the questionnaire in case of non-availability of the patient on day 7, the patient will be recalled to D8 and the data extrapolated according to the slope of the curve between D3 and D8; if the patient is still not available on D8, he will be recalled to D9 and the extrapolated data between D3 and D9.
II.STATISTICAL ASPECTS
II.1. Statistical justification for the sample size
58,921 patients were received in emergency consultation day and night during the year 2017. A sample of 1% of the population concerned will be constituted.
Patients received in day emergencies (44,191 patients in 2017) will be eligible. On average 121 patients are received daily in emergencies of day, about 600 per week (excluding weekend).
According to a previous study in the department, 50% of patients in care could not be included in the study or were lost to follow-up.
This leads to a number of 300 patients per week.
The study will therefore be conduct over 2 weeks, to include 600 patients, ie 1.3% of the population consulting
II.2. Description of statistical methods
A descriptive analysis of the characteristics of the sample will be performed (age, sex, reason for consultation, diagnosis, prior appointment test, average score of anxiety and pain scores on D0, D1, D3, D7, compliance with instructions and making follow-up appointments,), satisfaction rating, appreciation of the quality of medical care, politeness of staff, waiting time, assessment of the quality of the care setting, the information received, the treatment received, and the recommendation of the service to third parties will be made.
An analysis of the evolution of pain and anxiety scores between D0, D1, D3 and D7 will be performed.
Correlations between the type of treatment and the perceived pain as well as the type of treatment and the perceived anxiety will be made.
II.3. Method of taking into account missing or invalid data
Patients unreachable during the telephone follow-up period will be contacted the next day; the pain and anxiety scores will then be extrapolated from the previous data and the new data collected, by calculating the nearest point on the curve connecting these two data. If they are new unreachable, the data will be considered missing. Data from patients with missing data will be analyzed separately.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: QuestionnairesQuestionnaires for patients requiring dental emergencies care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patient reachable by telephone during the week following his / her care in the service
- Collection of the non-opposition of the patient for his participation in research
- Good understanding of the French language
Key exclusion criteria (1 listed)
- Patient with communication difficulties or difficulties in understanding the French language
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 |
|---|---|---|
| QuestionnairesDay 0 : Satisfaction questionnaire immediately after consultation Day 1, Day 3 and Day 7 : Telephone follow-up | Other | Patients |
Primary outcome
Pain scores evolution 24 hours after treatment
Time frame: Day 1
The pain is measured by simple digital scale (ENS). The patient notes his pain between 0 and 10. 0 being the lowest pain, 10 being the highest pain.
3 secondary outcomes
Pain scores evolution 3 days ans 7 days after treatment
Time frame: Day 3 and Day 7
Anxiety score evaluation bound to the care
Time frame: Day 0, Day 1, Day 3 and Day 7
Welcome quality evaluation from hospital staff
Time frame: The day of the emergency care (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 2 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Yves BOUCHER, PU-PH principal investigator
Assistance Publique Hoptiaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Dental Care, run by Assistance Publique - Hôpitaux de Paris 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 1 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 2 Mar 2021. 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?
Pain scores evolution 24 hours after treatment (time frame: Day 1). 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 2 Mar 2021.