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Homeless and Low Incomes People, RefugeesPASSDENTNCT03493750

Oral Evaluation by the Nurses From the Office of Access to Healthcare ("PASS") for Vulnerable People - PASSDENT Study

A study testing Oral and dental evaluation in people with Homeless and Low Incomes People, Refugees, run by Centre Hospitalier Annecy Genevois at 7 sites 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

Oral health is defined as the state of being free from dental or periodontal diseases and discomfort of oral cavity. WHO considers that oral hygiene is a major public health problem whatever the countries (developed, developing, and underdeveloped). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oral and dental evaluation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
7 sitesFrance
Study dates
2 Aug 2018to 15 Oct 2021
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

  • people helped by the PASS department
  • seen for the first or the second time in the PASS department
  • older than 18 years old
  • able to read and understand one of the following languages: French, English or the Albanian language of Kosovo
  • with or without insurance coverage
  • who had given their informed consent

Who cannot join

  • people without any identity document
  • psychiatric disease compromising the comprehension of the study
  • edentulous people or those with whole dental prosthesises
  • people who intend to leave the Annecy area within few days
  • people requiring emergency care whatever the reason
  • people not able to go alone to the dental practice
Show all 9Show fewer
  • pregnant or lactating women
  • people with law protection (i.e. under legal guardianship or curators)
  • people suffering from violence injuries

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites
  • ADOMA

    Annecy, 74000

  • Centre d'hébergement et de réinsertion sociale Saint-François

    Annecy, 74000

  • L'Herminette

    Annecy, 74000

  • L'Intervalle

    Annecy, 74000

  • La Halte

    Annecy, 74000

  • Ma Bohème

    Annecy, 74000

  • CH Annecy Genevois

    Pringy, 74374

Other trials in France

About this study

Official title: Oral Evaluation by the Nurses From the Office of Access to Healthcare ("PASS") for Vulnerable People as a Vector for the Detection of Oral Diseases to Improve Access to the Appropriate Healthcare Branch - PASSDENT Study

Oral health is defined as the state of being free from dental or periodontal diseases and discomfort of oral cavity. WHO considers that oral hygiene is a major public health problem whatever the countries (developed, developing, and underdeveloped).

The two main local medical problems are dental caries and periodontal diseases. Without appropriate treatments, both diseases can lead to local functional and esthetic damages, and can also have some negative repercussions on health.

Read more

Studies showed that there are great social disparities among people concerned by oral health issues. People in vulnerable situations (homeless and low incomes people, refugees) had less recourse to dental care. Those who consult do it less often and later. Reasons are mainly cost related, but also people in vulnerable situation don't perceive dental care as an important matter and don't know where and how to ask for help for having dental care.

PASS (french acronym for "Office of Access to Healthcare") departments, setting in both private and public health institutions, are intended to facilitate the access to care and the support of people in vulnerable situations, and their accompaniment in the steps necessary for the recognition of their rights.

Nurses of the Annecy PASS department had developed a questionnaire called "healthplan guide" that aim at helping them to screen and identify people with dental diseases among those in vulnerable situation, and to sensitize them about the importance of oral hygiene and how to improve it. This questionnaire is use in daily practice.

This study hypothesizes that more patients will be sensitized to benefit a dental examination in a dental practice if nurses use the "healthplan guide" questionnaire combined with an oral and dental evaluation.

Read the detailed description

Oral health is defined as the state of being free from dental or periodontal diseases and discomfort of oral cavity. WHO considers that oral hygiene is a major public health problem, as regard to number of people involved and the consequences either local (pain, functional deteriorations, teeth loss) or general (decreased quality of life, lower health status and increased mortality rate).

The two main local medical problems are dental caries and periodontal diseases ; among adults this is a major public health problem whatever the countries. Furthermore, the cost of these diseases is high, for example ranking fourth in developed countries health costs.

Dental caries is the most prevalent disease worldwide. The local production of organics acids by cariogenic bacteria located in the dental plaque, leading to the reduction of local pH, is responsible for enamel demineralisation and tooth decay. The local production of organic acids is due to the metabolism of fermentable sugars by bacteria of the dental plaque, saccharose being considered as the most cariogenic one. Dental caries occur when pH modification is durable. First, tooth decay affects only enamel and can be cured if appropriate measures favorising remineralisation are used. Second, when the enamel is totally destroyed, the hole inside dentin is irreversible and requires specific care.

Periodontal disease is also due to bacterias located in the dental plaque, with first, a local inflammatory reaction in the soft tissues of the tooth (gum and alveolar bone) that, second, lead to their destruction. This is a long lasting course disease.

Without appropriate treatments, both diseases can lead to local functional and esthetic damages, and can also have some negative repercussions on health, putting the patient at a higher risk of infectious endocarditis, cardiovascular or bronchopulmonary diseases, preterm deliveries, pre-eclampsias, poor control of diabetes, or increased rheumatoid arthritis exacerbations.

Furthermore, some other diseases are likely to favor bucco-dental diseases, such as diabetes, or immunosuppressive diseases for example AIDS.

Some medicines, particularly those inducing xerostomia increase the development of bucco-dental diseases. Alcohol and tobacco consumption is known to be an important risk factor.

Studies showed that there are great social disparities among people concerned by oral health issue. For example, people with low incomes have more missing teeth, dental caries needing care or avulsions, parodontal diseases and deficient oral hygiene. People in vulnerable situations (homeless and low incomes people, refugees) have less recourse to dental care. Those who consult do it less often and later. Reasons are mainly cost related, but also people in vulnerable situation don't perceive dental care as an important matter in absence of pain and don't know where and how to ask for help for having dental care.

In France, in 1998 an act (Loi d'orientation du 29 juillet 1998 "relative à la lutte contre les exclusions") implemented the permanent access to health care for people in vulnerable situations and created departments called PASS (french acronym for "Office of Access to Healthcare"). These structures, setting in both private and public health institutions, are intended to facilitate the access to care of people in vulnerable situations, and to support them throughout all the steps required to obtain recognition of their rights.

PASS-Annecy department was created in 2003 in Annecy hospital. In 2010, the French High Authority for Public Health published some recommendations on caries prevention; development of dental consultations for people in vulnerable situation in local structures such as PASS were encouraged.

After severe infections (endocarditis and face cellulitis) in two homeless people in Annecy hospital, nurses of the Annecy PASS department had developed a questionnaire called "healthplan guide" that aim at helping them to screen and identify people with dental diseases among those in vulnerable situation, and to sensitize them about the importance of oral hygiene and how to improve it. This questionnaire is use in daily practice. Nevertheless, despite sensitization with the "healthplan guide" use, few people among vulnerable one's went to the dental practice after the nurses made them an appointment.

This study hypothesizes that more patients will be sensitized to have a dental examination in dental practice if nurses will do an oral and dental evaluation combined with the use of the "healthplan guide" questionnaire.

Being tested
Oral and dental evaluation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral and dental evaluationOther

    Mouth inspection done by a nurse, in order to count missing, coloured, injured teeth, and evaluate dental plaque, halitosis, inflammatory gums, mucosal injuries, low masticatory surface.

Study groups in NCT03493750
Study groupRoleWhat they receive
Healthplan guide aloneNo interventionNurse applies the daily-practice questionnaire called "Healthplan guide" to screen and identify people with dental diseases, among those in vulnerable situation, and to sensitize them about the importance of oral hygiene and how to improve it. After that, the nurse has to state if, from her/his point of view the patient needs dental care or not. Whatever the answer, the nurse makes an appointment to a dental practice, in the 30 following days, and gives it to the patient with a free bus ticket. Randomization is done at that time. The dentist, blinded of the patient's group, makes a dental exam and says if the patient needs dental care or not. If care are indicated, they will be organized but outside this trial.
Oral and dental evaluationExperimentalAfter application of the "Healthplan guide", nurse statement of the need of dental care or not, making of an appointment to the dental practice and gift of a free bus ticket, if the patient is randomized in the experimental group, the nurse completes the evaluation with a mouth inspection in order to count missing, coloured, injured teeth, and evaluate dental plaque, halitosis, inflammatory gums, mucosal injuries, low masticatory surface. At the end of this exam, the nurse has to state again if, from her/his point of view the patient needs dental care or not. The dentist, blinded of the patient's group, makes a dental exam and says if the patient needs dental care or not. If care are indicated, they will be organised but outside this trial.
Receives: Other: Oral and dental evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of an oral evaluation realized by a nurse combined with a questionnaire compared with the use of the questionnaire alone

    Rate of people who go to the dental practice after an appointment booked by the nurse of the PASS structure

    Measured: 60 days

Secondary outcomes (3)
  1. Oral health care status of the study population

    Oral evaluation and oral hygien index done by dentists with only one evaluation form

    Measured: 1 day

  2. Relevance of the nurse in identifying patients requiring oral care

    Comparison of nurse and dentist evaluations concerning the need of dental care

    Measured: 1 day

  3. Quality of the oral evaluation done by trained nurses, in the experimental group only

    Agreement between nurse and dentist concerning number and location of missing, coloured, injured teeth (according to the World Dental Federation two-digit notation), dental plaque, halitosis, inflammatory gums, mucosal injuries, low masticatory surface.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2018
  2. Study start2 Aug 2018
  3. Primary completion15 Oct 2021
  4. Study completion15 Oct 2021

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Impact of an oral evaluation realized by a nurse combined with a questionnaire (the healthplan guide)
Masking
Single blind
Who is masked
Care provider
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03493750
Sponsor's protocol ID
P_2015_003
Other IDs
2015-A01878-41
Acronym
PASSDENT
Status last verified
Jul 2022
First submitted
3 Apr 2018
Last updated
20 Jul 2022
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 Oral and dental evaluation in people with Homeless and Low Incomes People, Refugees, run by Centre Hospitalier Annecy Genevois at 7 sites 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 6 inclusion and 9 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

Impact of an oral evaluation realized by a nurse combined with a questionnaire compared with the use of the questionnaire alone (time frame: 60 days). 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 20 Jul 2022.

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