Orofacial PainURGDENT-NWNCT04352881
Evaluation of Out of Hours Dental Emergency Treatments
An observational study of Orofacial Pain and Orofacial Edema, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orofacial Pain, Orofacial Edema, Dental Trauma
- What is being tested?
- Questionary patient
- How many people
- 369 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2020to 24 Apr 2021
- 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: patients seeking care at the dental emergency service at night (N) or week-end (WE) (2 samples)
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 consent of the patient for his participation in research
- Good understanding of the French languageExclusion Criteria:
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: Evaluation of the Management of Dental Emergencies During Night and Week-ends
For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients.
So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work.
Read more
This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE).
Attendance at night and during WE is important because it is sociologically and medically different from that of day and week. It is therefore important to complete this study by focusing on patients consulting the emergency room at night and during the weekend.
This work therefore responds to a request from the Odontology Emergency Reception Service (SAUO) of the Pitié-Salpêtrière Hospital Group. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room .
Read the detailed description
- Research progress Two investigators will take turns in the service for the search duration. They will be responsible for informing patients of the research upon their arrival in the service and 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 search 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:
- 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.
For the night sample : from 6:30 pm to 8 am Recall should be 24 hours after the care, but it seems not ethical or efficient to recall patients the night following ; an extension of 12 hours will be instaurated, taking then the recalls to 36h (D1), 84h (D3), and 180h (D7) after the care.
For the WE sample : from 8 am to 6:30 pm D1: 24 hours after the care D3: 72 hours after the care D7 :168 hours after the care
II.1.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. We wish to constitute a sample of 1% of the population concerned.
For the night sample The investigators are interested here in patients received in night emergencies, 26 050 patients in 2018. On average 72 patients are received daily in emergencies of day, about 504 per week.
According to a previous study in the department (15), 50% of patients in care could not be included in the study or were lost to follow-up.
This leads to a number of 252 analysable patients per week. The investigators will therefore conduct our study over 9 nights, to include 325 patients, ie 1.25% of the population consulting For the WE sample The investigators are interested here in patients received in Saturday and Sunday emergencies, 10 657 patients in 2018. On average 204 patients are received each week-end in emergencies of day.
According to a previous study in the department (15), 50% of patients in care could not be included in the study or were lost to follow-up.
This leads to a number of 102 analysable patients per week-end. The investigators will therefore conduct our study over 2 week-ends, to include 204 patients, ie 1.9% 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.
III. DATA MANAGEMENT III.1. Terms of data collection The research does not foresee the use of data extracted from existing information systems or from previously completed studies.
No nominative data will be collected as part of this research. The data will be rendered non-identifying. They must not in any case show in clear the names of the persons concerned or their address.
As part of this research, topics will be identified as follows:
N or W (depending on the Night or Week-end sample) - Chronological order of the person (3 digits) - first letter of the first name - first letter of last name The answers to the different questionnaires (completed by the patients and the interviewers) will be entered into an EXCEL file. This file will be protected by a password.
The seizure will be carried out by the coordinating investigator or one of those collaborators (dentist or student) declared in the center and trained in research at the end of each session.
III.2. Data circuit The investigators will collect the data directly from the patient during the consultation or during telephone interviews on paper forms (CRF).
This data will then be entered into an Excel database specifically created for the search.
The database will be kept on the computer of the odontology service at the Pitié-Salpêtrière hospital and will be protected by a password known only to research stakeholders.
Data analysis will be done by the principal investigator and the research stakeholders
- Conditions
- Orofacial Pain, Orofacial Edema, Dental Trauma, Oral Infection
- Being tested
- Questionary patient
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionary patientOther
Assessing pain reduction using a 4-step questionary
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score evolution measured by a 0-10 numeric scale (NS) where 0 is no pain and 10 the worst pain imaginable
Self reported measure of pain on the numeric scale 24h (Day 1) after the first visit (Day 0)
Measured: Day 1
Secondary outcomes (4)
Pain score evolution measured 3 days and 7 days after 1st visit, measured with a 0-10 numeric scale (NS) where 0 is no pain and 10 the worst pain imaginable
the pain is measured with the numeric scale
Measured: Day 3 and Day 7
welcoming quality from hospital staff
Perception of welcoming, waiting time will be measured with a 0-10 numeric scale where 0 is the worst score and 10 is the best score.
Measured: Day 1
anxiety score
Anxiety score evolution measured by a 0-10 numeric scale (NS) where 0 is no anxiety and 10 the worst anxiety imaginable. The patient anxiety will be measured by numeric scale at Day 0, Day+1, Day +3, Day+7
Measured: Day 0, Day 1, Day 3, Day 7
perception of the technical quality of the emergency treatment
The perception is measured just after care with a 0-10 NS where 0 is the worst score and 10 is the best score
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start10 Nov 2020
- Primary completion16 Apr 2021
- Study completion24 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352881
- Sponsor's protocol ID
- APHP191120
- Acronym
- URGDENT-NW
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2020
- Last updated
- 31 Jan 2022
- 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 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Management of Dental Emergencies During Night and Week-ends
- ClinicalTrials.gov ID
- NCT04352881
- Acronym / sponsor ID
- URGDENT-NW / APHP191120
- Conditions
- Orofacial Pain, Orofacial Edema, Dental Trauma, Oral Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 24 Apr 2021 (actual)
- First posted
- 20 Apr 2020 (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.
For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients.
So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work.
This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE).
Attendance at night and during WE is important because it is sociologically and medically different from that of day and week. It is therefore important to complete this study by focusing on patients consulting the emergency room at night and during the weekend.
This work therefore responds to a request from the Odontology Emergency Reception Service (SAUO) of the Pitié-Salpêtrière Hospital Group. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room .
Detailed description
- Research progress Two investigators will take turns in the service for the search duration. They will be responsible for informing patients of the research upon their arrival in the service and 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 search 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:
- 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.
For the night sample : from 6:30 pm to 8 am Recall should be 24 hours after the care, but it seems not ethical or efficient to recall patients the night following ; an extension of 12 hours will be instaurated, taking then the recalls to 36h (D1), 84h (D3), and 180h (D7) after the care.
For the WE sample : from 8 am to 6:30 pm D1: 24 hours after the care D3: 72 hours after the care D7 :168 hours after the care
II.1.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. We wish to constitute a sample of 1% of the population concerned.
For the night sample The investigators are interested here in patients received in night emergencies, 26 050 patients in 2018. On average 72 patients are received daily in emergencies of day, about 504 per week.
According to a previous study in the department (15), 50% of patients in care could not be included in the study or were lost to follow-up.
This leads to a number of 252 analysable patients per week. The investigators will therefore conduct our study over 9 nights, to include 325 patients, ie 1.25% of the population consulting For the WE sample The investigators are interested here in patients received in Saturday and Sunday emergencies, 10 657 patients in 2018. On average 204 patients are received each week-end in emergencies of day.
According to a previous study in the department (15), 50% of patients in care could not be included in the study or were lost to follow-up.
This leads to a number of 102 analysable patients per week-end. The investigators will therefore conduct our study over 2 week-ends, to include 204 patients, ie 1.9% 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.
III. DATA MANAGEMENT III.1. Terms of data collection The research does not foresee the use of data extracted from existing information systems or from previously completed studies.
No nominative data will be collected as part of this research. The data will be rendered non-identifying. They must not in any case show in clear the names of the persons concerned or their address.
As part of this research, topics will be identified as follows:
N or W (depending on the Night or Week-end sample) - Chronological order of the person (3 digits) - first letter of the first name - first letter of last name The answers to the different questionnaires (completed by the patients and the interviewers) will be entered into an EXCEL file. This file will be protected by a password.
The seizure will be carried out by the coordinating investigator or one of those collaborators (dentist or student) declared in the center and trained in research at the end of each session.
III.2. Data circuit The investigators will collect the data directly from the patient during the consultation or during telephone interviews on paper forms (CRF).
This data will then be entered into an Excel database specifically created for the search.
The database will be kept on the computer of the odontology service at the Pitié-Salpêtrière hospital and will be protected by a password known only to research stakeholders.
Data analysis will be done by the principal investigator and the research stakeholders
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients seeking care at the dental emergency service at night (N) or week-end (WE) (2 samples)
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 consent of the patient for his participation in research
- Good understanding of the French languageExclusion Criteria:
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 |
|---|---|---|
| Questionary patientAssessing pain reduction using a 4-step questionary | Other | – |
Primary outcome
Pain score evolution measured by a 0-10 numeric scale (NS) where 0 is no pain and 10 the worst pain imaginable
Time frame: Day 1
Self reported measure of pain on the numeric scale 24h (Day 1) after the first visit (Day 0)
4 secondary outcomes
Pain score evolution measured 3 days and 7 days after 1st visit, measured with a 0-10 numeric scale (NS) where 0 is no pain and 10 the worst pain imaginable
Time frame: Day 3 and Day 7
welcoming quality from hospital staff
Time frame: Day 1
anxiety score
Time frame: Day 0, Day 1, Day 3, Day 7
perception of the technical quality of the emergency treatment
Time frame: Day 1
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 31 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Orofacial Pain and Orofacial Edema, 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 31 Jan 2022. 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 score evolution measured by a 0-10 numeric scale (NS) where 0 is no pain and 10 the worst pain imaginable (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 31 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.