NCT07399925

Brief Summary

With the ageing of the French population, the number of elderly people loosing their autonomy is increasing, leading to a growing need for care in residential establishments for dependent elderly people . For multiple reasons, the oral and dental health of the elderly is often when they're admitted to a nursing home (financiary issues, loss of mobility, cognitive impairement, etc.). It can continue to deteriorate after admission du to communication difficulties between care team and dentists. As these various constraints can limit the monitoring and management of the consequences of oral senescence, it is easy to understand the oral health deterioration in nursing home residents. This worsening in oral health is all the more worrying because residents rarely express the need for care, until emergency. This lack of complaints calls for even greater vigilance. While general hygiene care is well carried out, the majority of nursing staff are uncomfortable with oral hygiene care, which sometimes end up neglected or insufficient. Among the reasons that could explain this lack of care, nursing homes staff often speak of a reluctance to carry them out, a lack of knowledge, or even a fear of investing in this oral sphere. The purpose of this study is to demonstrate that nursing staff (nurse, orderlies, medical-psychological assistants and hospital service agents) oral health formation will help the development of knowledge and skills, and will improve the quality of life related to oral health of dependant people, while decreasing nursing staff anxiety levels in regards to dental care. To this end, before and 6 months after training in oral hygiene care for carers, the quality of life in relation to the oral health of residents will be assessed using the GOHAI questionnaire. Caregivers' anxiety levels will be assessed using the STAI-Y questionnaire. At the end of the training, two caregivers will be designated as oral health referents in each nursing home and a support unit will be set up. Supporting documents to help make the decision to call the dentist and care protocols left on site will complete this system.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Oct 2027

First Submitted

Initial submission to the registry

January 29, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

March 6, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

January 29, 2026

Last Update Submit

March 16, 2026

Conditions

Oral Health Training

Keywords

Nursing homeAgedQuality of health careAnxietyOral health trainingQuality of life

Outcome Measures

Primary Outcomes (1)

  • Changes in the oral health-related quality of life of nursing home residents.

    Measurement of oral health-related quality of life score, defined using the Geriatric Oral Health Assessment Index (GOHAI) before (D0) and 6 months after caregiver training (M6). In order to assess the link between this differential and the initial GOHAI score observed in the patient before the intervention, a linear regression model of the 'change-score model' type will be constructed after centring the variables.

    6 months

Secondary Outcomes (6)

  • Healthcare professionals' anxiety levels changes

    6 months

  • Alignment between training, training tools and the needs of caregivers.

    During training for healthcare professionals on oral hygiene and oral health, between day 7 and day 30

  • Changes in oral health care pathways for nursing home residents.

    6 months

  • Association between residents' quality of life related to oral health and caregivers' anxiety levels.

    6 months

  • Association between residents' age at inclusion and variations in GOHAI

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Residents / Caregivers group

EXPERIMENTAL

Caregivers : all staff providing oral care to residents (registered nurses, nursing assistants, medical-psychological assistants, hospital assistant service occupational therapists) Residents: mentally independent patients who have been residing in a nursing home for at least three months.

Other: Caregivers training in oral health in nursing homes

Interventions

Caregivers training in oral health in nursing homesOTHER

Training for healthcare workers on oral hygiene and health in nursing homes will be organised around two modules. Modules will aim to improve/update the specific knowledge and skills required to provide oral care to dependent residents in order to reduce the level of anxiety that may be associated with it. To ensure that all caregivers have acquired the training content, an assessment will be carried out at the end of each module in the form of a quiz. At the end of this training course, a decision tree on 'Should I call the dentist?', summary sheets of the training course and protocol sheets will be made available in the various nursing homes to help maintain the knowledge acquired during the training and guide caregivers in organizing the care pathway.

Residents / Caregivers group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Are aged 65 or over.
  • Are present in the facility.
  • Are mentally independent (MMS score ≥ 20 assessed within the last 12 months).
  • Consent participating the study, or who have obtained consent from a legal tutor where applicable.
  • have been present full-time in the nursing home for at least 3 months.
  • Speak and understand French.
  • Have signed the non-objection form.

You may not qualify if:

  • Those who are unable to understand or respond to the questionnaire.
  • Those who are not affiliated with a social insurance.
  • Those receiving palliative cares.
  • Those who refuse oral hygiene cares.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Nantes, 44000, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Oral HealthNursing Homes

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

HealthPopulation CharacteristicsResidential FacilitiesHealth FacilitiesHealth Care Facilities Workforce and Services

Central Study Contacts

Yoann MAITRE, Dr

CONTACT

+33 02 53 48 28 35yoann.maitre@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 10, 2026

Study Start

March 6, 2026

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)