ELDER Study
Research type
Research Study
Full title
Improving the oral health of older adults using milk supplemented with fluoride and probiotics: An interventional feasibility study and pilot RCT
IRAS ID
316798
Contact name
Vida Zohoori
Contact email
Sponsor organisation
Teesside University
ISRCTN Number
ISRCTN18536057
Duration of Study in the UK
1 years, 2 months, 7 days
Research summary
Increased life expectancy and improvement in oral health have resulted in an increased number of older adults retaining some of their natural teeth into old age. Yet, cohort studies on the oral health of older adults reveal dental caries as a major global health problem associated with high costs for society. Poor oral health is also associated with other health conditions including malnutrition, particularly in settings such as care homes.
A key part of supporting the health, wellbeing and dignity of older people is, therefore, to help them maintain good oral health and consequently general health by developing novel strategies to prevent and manage carious lesions. Although fluoride remains the most effective and economical protective agent against dental caries, its effectiveness could be boosted when combined with other anti-caries agents such as probiotics. Provision of milk supplemented with fluoride and/or probiotics could offer a potentially cost-effective method for caries prevention in older adults, particularly those living in care homes.
Our study is aimed to explore whether milk supplemented with fluoride and/or probiotics is efficient, acceptable and feasible to improve the oral health of older adults.
In a four-arm, parallel-group, cluster randomised controlled pilot trial, we will recruit 240 older adults, aged 65+y, from care homes and assign them randomly to one of the study arms: (a) milk, (b) milk + fluoride, (c) milk + probiotics, and (d) milk + fluoride + probiotics. The participants will be instructed to drink 200 ml of milk once per day for 9 months. We will perform oral examinations and collect samples of whole saliva from participants at their care homes at baseline, and after the follow-up period of 9 months. Samples will be cultivated to measure bacterial and fungal growth.
We will collect data on the proportion of older adults that agree to take part and that complete the intervention; the feasibility of collecting outcome data; the time spent on recruiting participants, and outcome data.
Our project, including partners from the UK, Sweden and Denmark, will expand the current extremely limited knowledge on the use of probiotic supplements as an adjunct to a fluoride programme on caries management in older adults; and will generate valuable data for a larger multicentre study. Our findings ultimately could guide public health policy- and decision-making for populations.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0258
Date of REC Opinion
28 Nov 2022
REC opinion
Further Information Favourable Opinion