NCT04815434

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
Last Updated

July 2, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 23, 2021

Last Update Submit

June 30, 2021

Conditions

Keywords

Disable personChronic diseaseQualitative researchOral HealthSociological factorsQuality of lifeBody imageAdult

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Day 1

Secondary Outcomes (1)

  • Interview "Ability of the ICF to contextualize experiences of oral health"

    Day 1

Study Arms (1)

Adults with disabilities and complex health conditions

Interviews, experience of the mouth and oral health and function

Other: Interview

Interventions

Interviews will be conducted.

Adults with disabilities and complex health conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with self-defined disabilities and/or complex health conditions

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFR d'Odontologie

Clermont-Ferrand, AURA, 63000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic Disease

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

April 7, 2021

Primary Completion

May 27, 2021

Study Completion

May 27, 2021

Last Updated

July 2, 2021

Record last verified: 2021-03

Locations