Improving the oral health of older adults using milk supplemented with fluoride and probiotics

INTERVENTION: 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 nine 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 m CONDITION: Improve oral health of older adults living in care homes ; Oral Health PRIMARY OUTCOME: ; 1. Acceptability of the supplemented milk measured by assessing the number of participants agreeing to take part and going to complete the study at baseline and at 9 months; 2. Compliance with the intervention programme measured through a semi‐structured questionnaire collected every month for the nine‐month period of intervention; 3. Potential clinical dental results of the intervention:; 3.1 Root caries measured using the Petersson and Baysan grading score at baseline and 9 months; 3.2 Gingival inflammation measured using the gingival index scoring system at baseline and 9 months; 4. Bacterial and fungal counts in saliva and supragingival plaque estimated using non‐selective blood agar and sabouraud dextrose medium with an aid of a stereo‐microscope at baseline and 9 months; SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 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