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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Groupe Hospitalier Pitié-Salpétrière

    Paris, 75013

Other trials in France

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
  1. 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):

  1. Patient information on the research when he arrives in the service; explanation of its objectives, its modalities and constraints.
  2. Verification of eligibility criteria.
  3. Collection of the patient's non-opposition by the dentist during the consultation
  4. 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.
  5. Patient filling in the satisfaction questionnaire immediately after consultation. Telephone follow-up (D1, D3, D7):
  6. 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
  7. 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.
  8. 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 groups in NCT03819036
Study groupRoleWhat they receive
PatientsExperimentalQuestionnaires 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.

  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.

    Measured: Day 1

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted28 Jan 2019
  2. Study start18 Feb 2019
  3. Primary completion18 Jul 2019
  4. Study completion30 Jul 2020

Resources

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)
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

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.

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