Qualitative Assessment of Emergency Dental Treatments (URGDENT)
Primary Purpose
Dental Care
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by

About this trial
This is an interventional other trial for Dental Care focused on measuring Dental emergency, Toothache, Tooth pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient with communication difficulties or difficulties in understanding the French language
Sites / Locations
- Groupe Hospitalier Pitié-Salpétrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Questionnaires for patients requiring dental emergencies care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Anxiety score evaluation bound to the care
Anxiety is measured by simple digital scale (ENS) from 0 to 10.
Welcome quality evaluation from hospital staff
The reception, cleanliness quality and waiting time will be measured by ENS scale from 0 to 10.
Full Information
NCT ID
NCT03819036
First Posted
January 25, 2019
Last Updated
March 1, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03819036
Brief Title
Qualitative Assessment of Emergency Dental Treatments
Acronym
URGDENT
Official Title
Qualitative Assessment of Emergency Dental Treatments in the Pitie Salpetriere Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
July 18, 2019 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
I. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Care
Keywords
Dental emergency, Toothache, Tooth pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
583 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Questionnaires for patients requiring dental emergencies care
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Day 0 : Satisfaction questionnaire immediately after consultation Day 1, Day 3 and Day 7 : Telephone follow-up
Primary Outcome Measure Information:
Title
Pain scores evolution 24 hours after treatment
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Pain scores evolution 3 days ans 7 days after treatment
Description
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.
Time Frame
Day 3 and Day 7
Title
Anxiety score evaluation bound to the care
Description
Anxiety is measured by simple digital scale (ENS) from 0 to 10.
Time Frame
Day 0, Day 1, Day 3 and Day 7
Title
Welcome quality evaluation from hospital staff
Description
The reception, cleanliness quality and waiting time will be measured by ENS scale from 0 to 10.
Time Frame
The day of the emergency care (Day 0).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patient with communication difficulties or difficulties in understanding the French language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves BOUCHER, PU-PH
Organizational Affiliation
Assistance Publique Hoptiaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Qualitative Assessment of Emergency Dental Treatments
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