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

Improving the oral health of older adults using milk supplemented with fluoride and probiotics: An interventional feasibility study and pilot randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18536057

Enrollment

240

Registered

2022-11-29

Start date

2023-03-09

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improve oral health of older adults living in care homes Oral Health

Interventions

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 woul

Eligibility

Sex/Gender

All

Age

65 Years to 120 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 18/08/2023: 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 6 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 6 months 3.2 Gingival inflammation measured using the gingival index scoring system at baseline and 6 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 6 months Previous primary outcome measure: 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	—

Measure

Time frame

Current primary outcome measure as of 18/08/2023: 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 6 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 6 months 3.2 Gingival inflammation measured using the gingival index scoring system at baseline and 6 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 6 months Previous primary outcome measure: 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

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026