AdultFAULKSNCT04815434
Experience and Understanding of the Mouth, Oral Health and Function Amongst Adults With Disabilities and Complex Health Conditions.
An observational study of Adult and Disability, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Oral health is the one of the commonest causes of health problems in the world, with almost all individuals suffering from reduced oral health at some stage over their life span. As such, oral health is a major public health issue and a major consumer of health spending. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult, Disability, Chronic Disease
- What is being tested?
- Interview
- Type of treatment
- Pill or oral medicine
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2021to 27 May 2021
- Phase
- Observational
- 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
Study population: Adults with self-defined disabilities and/or complex health conditions
Who may be able to join
- adults 18 years of age or over on day of data collection
- adults with self-defined disabilities and/or complex health conditions
- agreement to participate from the disabled adult or his/her carer
Who cannot join
- adults under 18 years of age
- adults without self-defined disabilities and/or complex health conditions
- refusal to participate from the disabled adult or his/her carer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experience and Understanding of the Mouth, Oral Health and Function Amongst
Oral health is the one of the commonest causes of health problems in the world, with almost all individuals suffering from reduced oral health at some stage over their life span. As such, oral health is a major public health issue and a major consumer of health spending. Poor oral health results in pain, infection, structural degradation, functional restrictions in chewing, swallowing and speech, change in facial appearance, social stigma, altered body image, and reduced capacity to participate in social events, amongst others. Global problems of human functioning, disability, health and environment in turn affect oral status in many complex ways (for example, ability to maintain oral hygiene, nutritional restrictions, neuromotor incapacity, dysphagia, ability to access and cooperate with treatment, etc). Disability arises from a social environment that fails to enable everyone to access it regardless of his or her impairment. Disabilities are thus socially created and not dependent on the individual's type or location of impairment. There is currently very limited qualitative research exploring perceptions of the mouth, or oral health within a social environment, from the perspective of disabled adults. No universal, holistic, comprehensive tool exists to describe oral health, the functional impact of oral health, and the environmental factors influencing oral health within the biopsychosocial model. It has been suggested that a framework for such an instrument may be supplied by the International Classification of Functioning, Disability and Health (ICF: World Health Organisation, 2001) This research seeks to address these gaps by describing perceptions of the mouth from the perspective of adults with disabilities and complex health conditions, and by linking this qualitative data to the ICF in order to assess the feasibility of using the ICF to conceptualise oral health. Adults with disabilities and complex health conditions were chosen for this ICF core set preliminary study as existing literature suggests that these respondents would accumulate not only a high level of oral health need but also experience high impact of functioning and environment on oral health.
Read the detailed description
A Case Record Form will be completed during the interview with the participant and/or their carer. The form will record data relating to sociodemographics along with a subjective appreciation of general health, oral health and mental health. Sociodemographic data will include age, gender, level of education (age on completion / highest level), occupation, income band and housing tenure (own house, parent's house, institution).
An investigator will undertake the interviews. Before starting data collection, the procedure of the session will be explained and the aims of the study presented in lay terms. The investigator will state that the individual has the possibility to refuse or withdraw his/her participation at any time without consequences, and on simple request. Where possible, the interviews will take place face to face, but may be undertaken over the telephone or by video-conferencing if necessary. Audio recording will be undertaken during each interview. During the interview, field notes will be taken in order to record elements of non-verbal communication. The investigator will use a indicative topic guide covering six areas to initiate a discussion. The investigator will use a indicative topic guide covering six areas to initiate a discussion:
- How would you describe your health and your oral health?
- Do you have any health conditions which affect your mouth in any way?
- If so, which part of your mouth is affected and how?
- What is the impact of your oral health on your daily life?
- Do your living conditions or your social environment impact on your oral health in any way?
- If you had to describe the impact of your oral health on daily life to someone what would you say? Each question includes a series of prompts to assist participants in answering the question.
It is anticipated that each interview will take around 60 minutes to complete.
- Conditions
- Adult, Disability, Chronic Disease, Oral Health
- Being tested
- Interview
- Keywords
- Disable person, Chronic disease, Qualitative research, Oral Health, Sociological factors, Quality of life, Body image, Adult
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interviews will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Adults with disabilities and complex health conditions | Interviews, experience of the mouth and oral health and function Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview "experiences of the mouth in adults with disabilities and complex health conditions"
Interview will allow to gain understanding of the experiences of the mouth in adults with disabilities and complex health conditions
Measured: Day 1
Interview "Inter-relationships between the mouth, oral health, functioning and the social environment amongst adults with disabilities and complex health conditions."
Interview will allow to gain understanding of the inter-relationships between the mouth, oral health, functioning and the social environment amongst adults with disabilities and complex health conditions.
Measured: Day 1
Secondary outcomes (1)
Interview "Ability of the ICF to contextualize experiences of oral health"
Interview will allow to gain insight into the ability of the ICF to contextualise experiences of oral health
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start7 Apr 2021
- Primary completion27 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdultStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Odontologie Clinique (CROC), Clermont-Ferrand, Dental institute, King's College, Londres, UK, University of Dublin, Trinity College, Cork Dental School, Irlande
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815434
- Sponsor's protocol ID
- RNI 2020 FAULKS
- Acronym
- FAULKS
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bogner MS, Scambler S, Eschevins C, Faulks D. How Do Persons With Disabilities and/or Complex Health Conditions Perceive Oral Health? A Qualitative Study. Community Dent Oral Epidemiol. 2025 Feb;53(1):77-89. doi: 10.1111/cdoe.13008. Epub 2024 Oct 10.
PubMed 39390669
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience and Understanding of the Mouth, Oral Health and Function Amongst
- ClinicalTrials.gov ID
- NCT04815434
- Acronym / sponsor ID
- FAULKS / RNI 2020 FAULKS
- Conditions
- Adult, Disability, Chronic Disease, Oral Health
- Keywords
- Disable person, Chronic disease, Qualitative research, Oral Health, Sociological factors, Quality of life, Body image, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Odontologie Clinique (CROC), Clermont-Ferrand, Dental institute, King's College, Londres, UK, University of Dublin, Trinity College, Cork Dental School, Irlande
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 25 Mar 2021 (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 the one of the commonest causes of health problems in the world, with almost all individuals suffering from reduced oral health at some stage over their life span. As such, oral health is a major public health issue and a major consumer of health spending. Poor oral health results in pain, infection, structural degradation, functional restrictions in chewing, swallowing and speech, change in facial appearance, social stigma, altered body image, and reduced capacity to participate in social events, amongst others. Global problems of human functioning, disability, health and environment in turn affect oral status in many complex ways (for example, ability to maintain oral hygiene, nutritional restrictions, neuromotor incapacity, dysphagia, ability to access and cooperate with treatment, etc). Disability arises from a social environment that fails to enable everyone to access it regardless of his or her impairment. Disabilities are thus socially created and not dependent on the individual's type or location of impairment. There is currently very limited qualitative research exploring perceptions of the mouth, or oral health within a social environment, from the perspective of disabled adults. No universal, holistic, comprehensive tool exists to describe oral health, the functional impact of oral health, and the environmental factors influencing oral health within the biopsychosocial model. It has been suggested that a framework for such an instrument may be supplied by the International Classification of Functioning, Disability and Health (ICF: World Health Organisation, 2001) This research seeks to address these gaps by describing perceptions of the mouth from the perspective of adults with disabilities and complex health conditions, and by linking this qualitative data to the ICF in order to assess the feasibility of using the ICF to conceptualise oral health. Adults with disabilities and complex health conditions were chosen for this ICF core set preliminary study as existing literature suggests that these respondents would accumulate not only a high level of oral health need but also experience high impact of functioning and environment on oral health.
Detailed description
A Case Record Form will be completed during the interview with the participant and/or their carer. The form will record data relating to sociodemographics along with a subjective appreciation of general health, oral health and mental health. Sociodemographic data will include age, gender, level of education (age on completion / highest level), occupation, income band and housing tenure (own house, parent's house, institution).
An investigator will undertake the interviews. Before starting data collection, the procedure of the session will be explained and the aims of the study presented in lay terms. The investigator will state that the individual has the possibility to refuse or withdraw his/her participation at any time without consequences, and on simple request. Where possible, the interviews will take place face to face, but may be undertaken over the telephone or by video-conferencing if necessary. Audio recording will be undertaken during each interview. During the interview, field notes will be taken in order to record elements of non-verbal communication. The investigator will use a indicative topic guide covering six areas to initiate a discussion. The investigator will use a indicative topic guide covering six areas to initiate a discussion:
- How would you describe your health and your oral health?
- Do you have any health conditions which affect your mouth in any way?
- If so, which part of your mouth is affected and how?
- What is the impact of your oral health on your daily life?
- Do your living conditions or your social environment impact on your oral health in any way?
- If you had to describe the impact of your oral health on daily life to someone what would you say? Each question includes a series of prompts to assist participants in answering the question.
It is anticipated that each interview will take around 60 minutes to complete.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with disabilities and complex health conditions | – | Other: InterviewInterviews, experience of the mouth and oral health and function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with self-defined disabilities and/or complex health conditions
Key inclusion criteria (3 listed)
- adults 18 years of age or over on day of data collection
- adults with self-defined disabilities and/or complex health conditions
- agreement to participate from the disabled adult or his/her carer
Key exclusion criteria (3 listed)
- adults under 18 years of age
- adults without self-defined disabilities and/or complex health conditions
- refusal to participate from the disabled adult or his/her carer
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 |
|---|---|---|
| InterviewInterviews will be conducted. | Other | Adults with disabilities and complex health conditions |
Primary outcome
Interview "experiences of the mouth in adults with disabilities and complex health conditions"
Time frame: Day 1
Interview will allow to gain understanding of the experiences of the mouth in adults with disabilities and complex health conditions
Interview "Inter-relationships between the mouth, oral health, functioning and the social environment amongst adults with disabilities and complex health conditions."
Time frame: Day 1
Interview will allow to gain understanding of the inter-relationships between the mouth, oral health, functioning and the social environment amongst adults with disabilities and complex health conditions.
1 secondary outcome
Interview "Ability of the ICF to contextualize experiences of oral health"
Time frame: Day 1
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 7 Aug 2026.
- Results publication: PubMed 39390669Bogner MS, Scambler S, Eschevins C, Faulks D. How Do Persons With Disabilities and/or Complex Health Conditions Perceive Oral Health? A Qualitative Study. Community Dent Oral Epidemiol. 2025 Feb;53(1):77-89. doi: 10.1111/cdoe.13008. Epub 2024 Oct 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult and Disability, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 3 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 7 Aug 2026. 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?
Interview "experiences of the mouth in adults with disabilities and complex health conditions" (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04815434, which also lists 1 linked publication.
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 7 Aug 2026.