The Oral Health for Brain Health (Mysmile) Study
Research type
Research Study
Full title
Feasibility study: Can reducing periodontal infection (gum disease) slow the progression of cognitive impairment associated with Alzheimer's disease.
IRAS ID
315223
Contact name
Nicola X West
Contact email
Sponsor organisation
United Hospitals Bristol NHS Foundation Trust
ISRCTN Number
ISRCTN11832395
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Adults aged 60+ with Mild Cognitive Impairment (MCI) or early stage Alzheimer's Disease (AD) and capacity to consent will be recruited to the study. As well as a diagnosis of AD or MCI, participants must have gum disease, which will be assessed at screening by a study dentist. As gum disease is very prevalent as we get older it is likely that most participants who are screened will have sufficient gum disease to qualify for study inclusion. Participants will be asked to have a study partner who can attend at least the first appointment when capacity to consent is determined.
Eligible participants who give informed consent will be allocated at random to either the control or the treatment group. Control group participants will be told they have gum disease, provided with a gum health care leaflet and an electric toothbrush, and advised to attend their dentist, but will not receive study treatment. Treatment group participants will be given the same gum health leaflet and an electric toothbrush, and allocated to a dental practice for gum disease treatment delivered by specially trained dentists in a way that is personal to the participant.
Both study groups will assessed for cognition and gum health at screening, 6 and 12 month and samples of blood and saliva will be taken at these visits so that the bacterial load and levels of some inflammatory proteins can be monitored over the course of the study. At the 12-month appointment participants will be asked to take part in a short interview to gather their thoughts about the study. For participants who join the study at the start of recruitment there will be a final 18-month assessment of cognition. Participants in the control group will be offered study treatment after they have completed the study.REC name
West of Scotland REC 5
REC reference
22/WS/0137
Date of REC Opinion
2 Nov 2022
REC opinion
Further Information Favourable Opinion