Improving the oral health of older adults using milk supplemented with fluoride and probiotics: An interventional feasibility study and pilot randomised controlled trial
Improve oral health of older adults living in care homes
Current intervention as of 18/08/2023: Trial intervention: The trial aims to recruit at least 240 Care Home Residents. A cluster randomised trial is required, as an individually randomised trial would be subject to the threat of contamination (unintentional drop-out and drop-in across treatment arms due to mixing up milk) and managing four different kinds of milk within a single care home would be infeasible. The consented care homes will be assigned randomly to one of the study arms: 1. Group 1: non-supplemented milk (placebo) 2. Group 2: milk supplemented with fluoride (5.0 mg flouride/l) 3. Group 3: milk supplemented with probiotics (Lactobacillus) 4. Group 4: milk supplemented with fluoride and probiotics. All subjects will be asked to drink a glass of plain/supplemented milk once daily, five days a week, for six months. Fluoridated milk or probiotics, or placebo (referred to as the Study product) will be administered by the resident’s routine caregiver during medicinal/meal rounds. The study product will be sourced from the manufacturer and transported to the study site. Fluoridated milk will be distributed in a small carton, and the probiotics will be provided as a powder in sealed sachets. The preferred route of administration is as follows: 1. The carton containing fluoridated milk is to be emptied into a tall glass and then consumed 2. The probiotic powder is to be dispensed in a spoon, then added to a prepared glass of skimmed milk/fluoridated milk, mixed well and then consumed Each care home will be provided with the manufacturer’s dossier detailing the composition of the probiotic form and fluoridated milk. After allocation, probiotic sachets will be distributed to the care home at the beginning of the trial, whereas milk (both skimmed & fluoridated) will be distributed to the trial sites weekly. Participants admitted to the hospital would not be expected to continue taking the study product during their hospital stay. Randomisation: The unit of
1. Full-time residents in a care home 2. Aged 65 years old and over 3. Have no acute or immunocompromised medical condition 4. Are able to give informed consent for participation 5. Have tolerance for dairy products
1. Receiving planned respite (temporary care home resident) or end-of-life or palliative care 2. Aged 64 years old and under 3. Lack the mental capacity to provide informed consent 4. Have any immunocompromised medical condition 5. Are currently taking/being prescribed regular probiotics 6. Have severe lactose intolerance 7. Do not have a working level of oral English