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Reducing oral bacteria in those with mild dementia

Feasibility study to reduce oral bacteria and improve periodontal health in those living with mild dementia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74980794
Enrollment
20
Registered
2016-05-27
Start date
2016-07-27
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Periodontitis (gum disease) in people living with mild dementia Oral Health Chronic periodontitis

Interventions

Carried out by dentists: 1. Standard dental health protocols for periodontitis 2. Periodontal monitoring Carried out by clinical psychologist: 3. Cognitive assessment and assessment of daily living

Sponsors

University of Bristol (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 29/05/2019: 1. Adults with mild dementia, such as sporadic early-stage AD, mild early stage familial AD, mixed dementia (most commonly AD and vascular dementia) and vascular dementia associated with cerebral amyloid angiopathy, mild cognitive impairment (MCI) 2. Cognitive scores that demonstrate the patient is likely to have the capacity to consent 3. Moderate to severe periodontitis 4. =2 sextants score 4 on Basic Periodontal Examination (BPE) 5. Minimum of 6 remaining teeth 6. A project partner (commonly a carer or friend) who will consent to take part in the study in this capacity and attend appointments with the participant Previous participant inclusion criteria: 1. Adults with mild dementia, such as sporadic early-stage AD, mild early stage familial AD, mixed dementia (most commonly AD and vascular dementia) and vascular dementia associated with cerebral amyloid angiopathy 2. Cognitive scores that demonstrate the patient is likely to have the capacity to consent 3. Moderate to severe periodontitis 4. =2 sextants score 4 on Basic Periodontal Examination (BPE) 5. Minimum of 6 remaining teeth 6. A project partner (commonly a carer or friend) who will consent to take part in the study in this capacity and attend appointments with the participant

Exclusion criteria

Exclusion criteria: 1. Insufficient capacity to consent 2. Previously fitted pacemaker 3. Allergy to essential oil mouthwash 4. Tobacco smoking 5. Uncontrolled systemic disease 6. Uncontrolled dental disease other than periodontitis 7. Pregnancy or breastfeeding 8. Severe renal impairment (GFR=30ml/min) 9. Those scoring =3 on the American Society of Anaesthesiologists (ASA) Physical Status Classification System 10. Those currently enrolled in another study whose inclusion/exclusion criteria state that while on the study they cannot enrol in new studies, such as the Oral Health Study

Design outcomes

Primary

MeasureTime frame
Measured on day 0, 6 months, 1 year and 2 years. Additional appointments will be required for periodontal stabilisation during the 2 years (exact timepoints cannot be specified). 1. Compliance: 1.1. Attendance of visits 1.2. Short questionnaire about ease of following the oral hygiene regime 2. Stabilisation of periodontitis: periodontal assessment to include: 2.1. Tooth mobility 2.2. Bone loss 2.3. Bleeding on probing 2.4. Presence of pus 2.5. Periodontal pocket depth 2.6. Plaque assessment as determined by Turesky plaque index 2.7. Saliva sample for bacterial load determination

Secondary

MeasureTime frame
Measured on day 0, 6 months, 1 year and 2 years. Additional appointments will be required for periodontal stabilisation during the 2 years (exact timepoints cannot be specified). Cognitive improvement: 1. Addenbrooke’s Cognitive Examination III 2. Alzheimer’s disease quality of life assessment (DEMQOL) 3. Bristol Activities of Daily Living (BADLS)

Countries

England, United Kingdom

Contacts

Public ContactNicola Hellin
dental-clinical-trials@bristol.ac.uk+44 (0)117 928 4314 (Dental Hospital)

Outcome results

None listed

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