Feasibility study: Can reducing periodontal infection (gum disease) slow the progression of cognitive impairment associated with Alzheimer's disease?

The Oral Health for Brain Health (Mysmile) Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11832395

Enrollment

Registered

2022-10-31

Start date

2023-01-09

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Oral and dental health, Alzheimers disease Oral Health

Interventions

At screening, consent will be taken by a researcher trained in taking informed consent from those suffering from memory loss, a project partner will be present at the screening appointment before capa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of either amnesic or multidomain mild cognitive Impairment with memory loss or early-stage Alzheimer's disease 2. Capacity to consent 3. Periodontitis (periodontal pockets of >4 mm with bleeding on probing) 4. Aged 60 years or over 5. A project partner to attend at least the first study appointment 6. A minimum of 6 teeth

Exclusion criteria

Exclusion criteria: 1. Lack of one or more of the inclusion criteria 2. Uncontrolled diabetes 3. Uncontrolled dental disease that is not periodontitis 4. Scores of >=3 on the American Society of Anaesthesiologists Physical-Status-Classification-System

Design outcomes

Primary

Measure	Time frame
Feasibility outcomes measured using patient records at the end of the study: 1. Recruitment rates 2. Compliance rates-intervention 3. Completion rates-data collection	—

Secondary

Measure	Time frame
1. Periodontal scores. Periodontal assessment: Bleeding on Probing (BOP) (yes/no); periodontal pocket depths (mm)-four gingival sites/tooth; dental plaque- O’Leary plaque index (yes/no)-four surfaces/tooth at screening, 6 months, 12 months 2. Cognitive scores. Cognitive assessment: Clinical Dementia Rating Sum of Boxes (CDR-SB): an appropriate and widely used primary outcome measures for early and late dementia. Alzheimer’s Disease Assessment Scale Cognitive subscale (ADAS-Cog11), and Bristol Activities of Daily Living Scale (BADLS), measuring functional ability at screening, 6 months, 12 months, 18 months 3. Blood levels of markers that are indicative of inflammation. Blood/saliva (laboratory research): Assessed for inflammatory response and bacterial load to confirm that bacteraemia and that pathogens have been reduced by the treatment at screening, 6 months, 12 months 4. Qualitative data (mini interview) regarding the perceived acceptability and success of the intervention at the end of the study	—

Measure

Time frame

1. Periodontal scores. Periodontal assessment: Bleeding on Probing (BOP) (yes/no); periodontal pocket depths (mm)-four gingival sites/tooth; dental plaque- O’Leary plaque index (yes/no)-four surfaces/tooth at screening, 6 months, 12 months 2. Cognitive scores. Cognitive assessment: Clinical Dementia Rating Sum of Boxes (CDR-SB): an appropriate and widely used primary outcome measures for early and late dementia. Alzheimer’s Disease Assessment Scale Cognitive subscale (ADAS-Cog11), and Bristol Activities of Daily Living Scale (BADLS), measuring functional ability at screening, 6 months, 12 months, 18 months 3. Blood levels of markers that are indicative of inflammation. Blood/saliva (laboratory research): Assessed for inflammatory response and bacterial load to confirm that bacteraemia and that pathogens have been reduced by the treatment at screening, 6 months, 12 months 4. Qualitative data (mini interview) regarding the perceived acceptability and success of the intervention at the end of the study

—

Countries

England, United Kingdom

Contacts

Public ContactNikki Hellin

nikki.hellin@bristol.ac.uk+44 7773579130

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026