Qualitative Assessment of Emergency Dental Treatments (URGDENT)

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ClinicalTrials.gov Identifier: NCT03819036

Recruitment Status : Completed

First Posted : January 28, 2019

Last Update Posted : March 2, 2021

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

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.

Condition or disease	Intervention/treatment	Phase
Dental Care	Other: Questionnaires	Not Applicable

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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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	583 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Intervention Model Description:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Qualitative Assessment of Emergency Dental Treatments in the Pitie Salpetriere Hospital
Actual Study Start Date :	February 18, 2019
Actual Primary Completion Date :	July 18, 2019
Actual Study Completion Date :	July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patients Questionnaires for patients requiring dental emergencies care	Other: Questionnaires Day 0 : Satisfaction questionnaire immediately after consultation Day 1, Day 3 and Day 7 : Telephone follow-up

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

Pain scores evolution 3 days ans 7 days after treatment [ Time Frame: Day 3 and Day 7 ]
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 [ Time Frame: Day 0, Day 1, Day 3 and Day 7 ]
Anxiety is measured by simple digital scale (ENS) from 0 to 10.
Welcome quality evaluation from hospital staff [ Time Frame: The day of the emergency care (Day 0). ]
The reception, cleanliness quality and waiting time will be measured by ENS scale from 0 to 10.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819036

Locations

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France
Groupe Hospitalier Pitié-Salpétrière
Paris, France, 75013

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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Principal Investigator:	Yves BOUCHER, PU-PH	Assistance Publique Hoptiaux de Paris

More Information

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Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT03819036
Other Study ID Numbers:	APHP180366 2018-A02692-53 ( Other Identifier: ANSM )
First Posted:	January 28, 2019 Key Record Dates
Last Update Posted:	March 2, 2021
Last Verified:	February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Assistance Publique - Hôpitaux de Paris:


Dental emergency Toothache Tooth pain

Additional relevant MeSH terms:

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Emergencies Disease Attributes Pathologic Processes

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