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

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ClinicalTrials.gov Identifier: NCT03493750
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de la Région d'Annecy

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Homeless and Low Incomes People, Refugees Other: Oral and dental evaluation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Impact of an oral evaluation realized by a nurse combined with a questionnaire (the healthplan guide)
Masking: Single (Care Provider)
Masking Description: Dentists are masked of the patient group
Primary Purpose: Prevention
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
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
No Intervention: Healthplan guide alone

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.

Experimental: Oral and dental evaluation

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.

Other: Oral and dental evaluation
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Oral health care status of the study population [ Time Frame: 1 day ]
    Oral evaluation and oral hygien index done by dentists with only one evaluation form

  2. Relevance of the nurse in identifying patients requiring oral care [ Time Frame: 1 day ]
    Comparison of nurse and dentist evaluations concerning the need of dental care

  3. Quality of the oral evaluation done by trained nurses, in the experimental group only [ Time Frame: 1 day ]
    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.



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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:

  • 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

Exclusion Criteria:

  • 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
  • pregnant or lactating women
  • people with law protection (i.e. under legal guardianship or curators)
  • people suffering from violence injuries

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): NCT03493750


Contacts
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Contact: Florence Ennahdi, PM +33450537031 fennahdi@ch-annnecygenevois.fr
Contact: Pascale Cony-Makhoul, MD +33450636431 pconymakhoul@ch-annecygenevois.fr

Locations
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France
ADOMA Recruiting
Annecy, France, 74000
Contact: Valerie Favre, Nurse       vfavre@ch-annecygenevois.fr   
Contact: Louisa Chevaleyre, Nurse    +33450636741    lchevaleyre@ch-annecygenevois.fr   
Centre d'hébergement et de réinsertion sociale Saint-François Recruiting
Annecy, France, 74000
Contact: Catherine Cognard, Nurse       ccognard@ch-annecygenevois.fr   
Contact: Louisa Chevaleyre, Nurse    +33450636741    lchevaleyre@ch-annecygenevois.fr   
L'Herminette Recruiting
Annecy, France, 74000
Contact: Emilie Cruz, Nurse       ecruz@ch-annecygenevois.fr   
Contact: Louisa Chevaleyre, Nurse    +33450636741    lchevaleyre@ch-annecygenevois.fr   
L'Intervalle Recruiting
Annecy, France, 74000
Contact: Emilie Cruz, Nurse       ecruz@ch-annecygenevois.fr   
Contact: Louisa Chevaleyre, Nurse    +33450636741    lchevaleyre@ch-annecygenevois.fr   
La Halte Recruiting
Annecy, France, 74000
Contact: Louisa Chevaleyre, Nurse    +33450636741    lchevaleyre@ch-annecygenevois.fr   
Ma Bohème Recruiting
Annecy, France, 74000
Contact: Dominique Forli, Nurse       dforli@ch-annecygenevois.fr   
Contact: Louisa Chevaleyre, Nurse    +33450636741    lchevaleyre@ch-annecygenevois.fr   
CH Annecy Genevois Recruiting
Pringy, France, 74374
Contact: Louisa Chevaleyre, Nurse    +33450636741    lchevaleyre@ch-annecygenevois.fr   
Sponsors and Collaborators
Centre Hospitalier de la Région d'Annecy
Investigators
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Principal Investigator: Louisa Chevaleyre, Nurse Centre Hospitalier Annecy Genevois

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Responsible Party: Centre Hospitalier de la Région d'Annecy
ClinicalTrials.gov Identifier: NCT03493750     History of Changes
Other Study ID Numbers: P_2015_003
2015-A01878-41 ( Other Identifier: ANSM (French National Drug Safety Agency) )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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