NCT03819036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
583

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

January 25, 2019

Last Update Submit

March 1, 2021

Conditions

Keywords

Dental emergencyToothacheTooth pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (3)

  • Pain scores evolution 3 days ans 7 days after treatment

    Day 3 and Day 7

  • Anxiety score evaluation bound to the care

    Day 0, Day 1, Day 3 and Day 7

  • Welcome quality evaluation from hospital staff

    The day of the emergency care (Day 0).

Study Arms (1)

Patients

EXPERIMENTAL

Questionnaires for patients requiring dental emergencies care

Other: Questionnaires

Interventions

Day 0 : Satisfaction questionnaire immediately after consultation Day 1, Day 3 and Day 7 : Telephone follow-up

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient with communication difficulties or difficulties in understanding the French language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Toothache

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Yves BOUCHER, PU-PH

    Assistance Publique Hoptiaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 28, 2019

Study Start

February 18, 2019

Primary Completion

July 18, 2019

Study Completion

July 30, 2020

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations