Improving the oral health of older people in care homes

Not Applicable

Completed

• Conditions: Oral health; Oral Health

• Registration Number: ISRCTN10276613
• Lead Sponsor: niversity College London

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34215322/ (added 05/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-17
• Study Completion: 2023-10-31
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Care home providers in London and Northern Ireland will be recruited using the following eligibility criteria:
1. Care homes will require to have a minimum of 20 residents (as approximately half are expected to be edentate)

Residents in the recruited care homes will be screened to determine whether they meet the eligibility criteria:
1. Over the age of 65 years
2. Dentate or partially dentate
3. Full-time resident in care facility

Exclusion Criteria

The exclusion criteria for the care homes will be:
1. Have high-dependency units and end-of-life care

The exclusion criteria for the residents will be:
1. Residents who are receiving end-of-life or palliative care
2. Residents with severe cognitive impairment (6-CIT score of 10 or higher)

A trained dental examiner will screen the participants for eligibility using a screening questionnaire covering the above criteria. Participants will also be asked the Six-item Cognitive Impairment Test (6-CIT) in order to assess their level of cognitive function. Residents with normal cognitive function (6-CIT score of 0-7) and those with mild cognitive impairment (6-CIT score of 8-9) will be included in the study, while those with severe cognitive impairment (6-CIT score of 10 or higher) will be excluded. As cognitive function tends to fluctuate in this population, we will attempt the 6-CIT screening test at different days and times on residents identified with severe cognitive impairment in order to identify potential time periods that would facilitate higher inclusion of participants in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TOPIC is a feasibility study and will primarily focus on the following feasibility-related outcomes:<br>1. Proportion of care homes that agree to participate in the study<br>2. Proportion of residents in the participating care that are eligible and able to consent<br>3. Proportion of eligible residents that agree to participate in the study<br>4. Proportion of participating residents in the intervention arm that receive the intervention per the protocol<br>5. Proportion of care homes and residents that remain in the study at 12 months follow-up<br>6. Proportion of completed measures used in the study (at least 75% completion rate required): i) oral health assessments; ii) quality of life questionnaires; iii) clinical measurement records; iv) oral symptoms checklist diaries

Secondary Outcome Measures

Name	Time	Method
1. Clinical outcomes, including the number of teeth with coronal and root caries lesions, the proportion of teeth with visible plaque and the proportion of teeth that bleed on probing (BoP), assessed by dental examiners at baseline and 12 months<br>2. Oral symptoms and domiciliary dental care: number of reported episodes of dental pain, sepsis, discomfort and domiciliary visits, reported weekly by care home staff and at baseline, 6 and 12 months by researchers<br>3. Health-related quality of life using EuroQol’s five dimensions (EQ-5D5L) at baseline, 6 and 12 months<br>4. Oral health-related quality of life using the OIDP at baseline, 6 and 12 months)<br>5. Oral health needs assessed with the OHAT by dental examiners at baseline and 12 months