Improving the oral health of older adults using milk supplemented with fluoride and probiotics
| ISRCTN | ISRCTN18536057 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18536057 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 316798 |
| Protocol serial number | IRAS 316798, CPMS 53328 |
| Sponsor | Teesside University |
| Funders | Eklund Foundation, National Institute for Health and Care Research |
- Submission date
- 04/10/2022
- Registration date
- 29/11/2022
- Last edited
- 29/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental caries continues to be a significant health problem among older people globally. This growing problem will consequently have significant financial repercussions for societies. There is, therefore, an urgent need to find feasible and cost-effective population-based oral health preventive measures for older people.
Although the role of fluoride in preventing carious lesions has been well established, implementation of effective individual- or community-based fluoride preventive measures has not occurred. Whilst effective professionally-applied interventions to prevent dental caries in older adults exist, there are significant barriers to their provision, particularly for care home residents.
Whilst supplemented milk with fluoride and/or probiotics would address many of the concerns, the efficacy of any programme will depend on the practicalities around provision as well as the feasibility, acceptability and cost-effectiveness of the programme to key stakeholders. Our research will explore supplemented milk as a community-based oral health intervention to reduce oral health inequalities among groups of older adults at high risk of poor oral health. To our knowledge, no study has previously investigated the feasibility and acceptability of the provision and implementation of supplemented milk for older adults living in care homes.
The 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. However, to the best of our knowledge, there is only one study in adults focusing on the role of supplemented milk in the prevention and management of dental/root caries. Although there are no pertinent criteria on how much evidence is needed for a clinical recommendation, it has been suggested that clinical recommendations should be based on at least two independent studies or one very large well-performed multicentre study.
Our project, which includes 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 standard fluoride programme on caries prevention and management in older adults. More importantly, our proposed pilot study will generate valuable and much-needed data for a larger multicentre study. Our findings ultimately could guide public health policy- and decision-making for populations.
Who can participate?
Senior full-time care home residents
What does the study involve?
The trial aims to recruit at least 240 care home residents who will be assigned randomly to one of the following study arms:
1. Group 1: non-supplemented milk (the placebo or dummy)
2. Group 2: milk supplemented with fluoride (5.0 mg fluoride/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.
A dentist who does not know which group each participant is in will perform baseline and follow-up dental examinations.
What are the possible benefits and risks of participating?
There are no direct benefits for participants taking part in the study.
There are no known side effects associated with the use of fluoridated milk or probiotics the basic two study products, used alone and as a combination as part of the study intervention.
1. The fluoridated milk provided to the study participants is the same dosage and frequency distributed to primary school children daily as part of the government scheme to reduce oral health inequalities among groups of young children at high risk of poor oral health in geographical areas with the highest disease burden (e.g. Blackpool Council)
2. According to the manufacturer’s information, the safety information sheet states that the probiotic strain LB21 used in this study has no reported consumer illness or injury and is a harmless product to use in humans (ELDER_Probiotic supplement (Manufacturer document_Safety Sheet) Though rare cases of secondary infection have been reported in immunosuppressed patients, and since the trial excludes residents with any immune-compromised condition, therefore no adverse events are expected based on the current data. Additionally, LB21 is well tolerated in younger children and therefore is reported to be provided as a food supplement to children aged 1-5 years to prevent the development of dental caries.
3. There is a trivial risk that a participant may experience gastrointestinal discomfort, for the first few days after taking them but this should subside quickly. All participants will be fully informed of all that is involved prior to being asked to consent and will be free to stop at any time. Although to our knowledge no such side effects have been reported for LB21 in the literature.
Where is the study run from?
Teesside University (UK)
When is the study starting and how long is it expected to run for?
May 2022 to February 2025
Who is funding the study?
1. National Institute for Health and Care Research (NIHR) (UK)
2. Eklund Foundation (Sweden)
Who is the main contact?
Prof. Vida Zohoori, V.Zohoori@tees.ac.uk
Kamalapriya Ajay, k.ajay@tees.ac.uk
Dr Sherley John, s.john@tees.ac.uk
Contact information
Principal investigator
School of Health and Life Sciences
Teesside University
Centuria Building
Middlesbrough
TS13BA
United Kingdom
 ORCID ID |
0000-0002-5929-1987 |
|---|---|
| Phone | +44 (0)1642342973 |
| v.zohoori@tees.ac.uk |
Scientific
School of Health and Life Sciences
Teesside University
Constantine Building
Middlesbrough
TS13BA
United Kingdom
| Phone | +44(0)7404987008 |
|---|---|
| s.john@tees.ac.uk |
Scientific
School of Health and Life Sciences
Teesside University
Constantine Building
Middlesbrough
TS1 3BA
United Kingdom
| Phone | +44(0)7440169196 |
|---|---|
| k.ajay@tees.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre open-label parallel-group four-arm prospective cluster-randomized placebo-controlled pilot trial |
| Secondary study design | Cluster randomised trial |
| Participant information sheet | 42538 ELDER_Probiotic supplement (Manufacturer document_Safety Sheet).pdf |
| Scientific title | Improving the oral health of older adults using milk supplemented with fluoride and probiotics: An interventional feasibility study and pilot randomised controlled trial |
| Study acronym | ELDER |
| Study objectives | 1. Milk is an efficient, acceptable, and feasible vehicle to deliver fluoride and probiotics on a community basis. 2. Milk supplemented with fluoride and probiotics is more effective than milk supplemented with either fluoride or probiotics in improving the oral health of older adults. |
| Ethics approval(s) | Approval 25/11/2022, East of England – Cambridge East Research Ethics Committee (Meeting held by video-conference via Zoom; +44 (0)207 104 8102; cambridgeeast.rec@hra.nhs.uk), ref: 22/EE/0258 |
| Health condition(s) or problem(s) studied | Improve oral health of older adults living in care homes |
| Intervention | 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 randomisation is the care home (cluster). The care homes will be randomised based on a 1:1 ratio to each available intervention arm or control arm. Trial staff at each trial site will inform the coordinating centre when there are four eligible care homes as they will be randomised in a set of four or six if two sister care homes belonging to the same chain are recruited. As the unit of randomisation is a care home, and the number of participants in each care home is expected to vary, blocking will be used to ensure a close balance of the number of participants (and not necessarily care homes) assigned to each arm. The allocation for a particular trial site will only be revealed after gaining informed consent (i.e., both at the care home level and the individual participant level) and baseline data collection. This approach reduces the threat of post-randomisation selection bias in cluster trials, as individual participants consent to be randomised to one of the four arms rather than being told which arm they have been allocated to if consent is only sought at the level of the care home. Blinding and concealment: As the ELDER trial is an open-label study, the participants, care home staff, and trial team (including the trial statistician and RNs conducting all assessments) will not be blinded to intervention assignment due to the nature of the trial procedure. However, the dentist performing the baseline and follow-up dental examination will be blinded to intervention and outcome assignment. Release of allocation only following enrolment, resident consent, baseline data collection, and dynamic randomisation of care homes using minimisation will ensure allocation concealment. Previous 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 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 randomisation is the care home (cluster). The care homes will be randomised based on a 1:1 ratio to each available intervention arm or control arm. Trial staff at each trial site will inform the coordinating centre when there are four eligible care homes as they will be randomised in a set of four or six if two sister care homes belonging to the same chain are recruited. As the unit of randomisation is a care home, and the number of participants in each care home is expected to vary, blocking will be used to ensure a close balance of the number of participants (and not necessarily care homes) assigned to each arm. The allocation for a particular trial site will only be revealed after gaining informed consent (i.e., both at the care home level and the individual participant level) and baseline data collection. This approach reduces the threat of post-randomisation selection bias in cluster trials, as individual participants consent to be randomised to one of the four arms rather than being told which arm they have been allocated to if consent is only sought at the level of the care home. Blinding and concealment: As the ELDER trial is an open-label study, the participants, care home staff, and trial team (including the trial statistician and RNs conducting all assessments) will not be blinded to intervention assignment due to the nature of the trial procedure. However, the dentist performing the baseline and follow-up dental examination will be blinded to intervention and outcome assignment. Release of allocation only following enrolment, resident consent, baseline data collection, and dynamic randomisation of care homes using minimisation will ensure allocation concealment. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Current primary outcome measure as of 18/08/2023: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Total final enrolment | 88 |
| Key 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 09/03/2023 |
| Date of final enrolment | 09/09/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Middlesbrough
TS1 3BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | 20/10/2022 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.4 | 20/09/2022 | 20/10/2022 | No | No |
| Protocol file | version 1.6 | 30/05/2023 | 18/08/2023 | No | No |
Additional files
- 42538 ELDER_Study Protocol_v1.4. 20Sep2022.pdf
- Protocol file
- 42538 ELDER_Probiotic supplement (Manufacturer document_Safety Sheet).pdf
- Participant information sheet
- ISRCTN18536057_Protocol_v1.6_30May2023.pdf
- Protocol file
Editorial Notes
29/11/2024: The following changes were made to the trial record:
1. The overall end date was changed from 30/11/2024 to 28/02/2025.
2. The intention to publish date was changed from 31/12/2024 to 31/03/2025.
3. The plain English summary was updated to reflect these changes.
11/10/2024: The overall end date was changed from 31/10/2024 to 30/11/2024.
30/07/2024: A scientific contact was added.
24/03/2024: The following changes were made:
1. The overall study end date was changed from 31/07/2024 to 31/10/2024.
2. The intention to publish date was changed from 20/08/2024 to 31/12/2024
3. The total final enrolment number was changed from 134 to 88.
08/03/2024: The following changes were made:
1. The overall study end date was changed from 31/03/2024 to 31/07/2024.
2. The intention to publish date was changed from 09/05/2024 to 20/08/2024.
04/09/2023: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The participant-level data sharing statement was added.
18/08/2023: The following changes have been made to the study record and the plain English summary was updated to reflect those changes:
1. The recruitment end date was changed from 09/06/2023 to 09/09/2023.
2. The overall study end date was changed from 30/12/2023 to 31/03/2024.
3. The interventions were changed.
4. The primary outcome measures were changed.
5. Uploaded protocol (not peer reviewed).
24/02/2023: The following changes have been made to the study record:
1. The recruitment start date has been changed from 09/01/2023 to 09/03/2023.
1. The recruitment end date has been changed from 09/04/2023 to 09/06/2023.
30/11/2022: Internal review.
20/10/2022: Trial's existence confirmed by The Eklund Foundation.
