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.
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
- Conditions the study is for
- Homeless and Low Incomes People, Refugees
- 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
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 group | Role | What they receive |
|---|---|---|
| Healthplan guide alone | No intervention | Nurse 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 evaluation | Experimental | After 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.
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)
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
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
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.
- First posted10 Apr 2018
- Study start2 Aug 2018
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homeless and Low Incomes People, RefugeesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louisa Chevaleyre, Nurse, Principal investigator, CH Annecy Genevois
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03493750
- Acronym / sponsor ID
- PASSDENT / P_2015_003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Impact of an oral evaluation realized by a nurse combined with a questionnaire (the healthplan guide)
| Arm | Type | Receives |
|---|---|---|
| Healthplan guide alone | No intervention | –Nurse 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 evaluation | Experimental | Other: Oral and dental evaluationAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral and dental evaluationMouth 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. | Other | Oral and dental evaluation |
Primary outcome
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
Rate of people who go to the dental practice after an appointment booked by the nurse of the PASS structure
3 secondary outcomes
Oral health care status of the study population
Time frame: 1 day
Relevance of the nurse in identifying patients requiring oral care
Time frame: 1 day
Quality of the oral evaluation done by trained nurses, in the experimental group only
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa Chevaleyre, Nurse principal investigator
CH Annecy Genevois
7 sites in 1 country: see every site and its status.
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.