Control of periodontal inflammation, systemic inflammatory responses and cognitive decline in Alzheimer?'s disease

• Register: ISRCTN
• Last refreshed on: 30 April 2018
• Main ID: ISRCTN34471493
• Date of registration: 16/08/2013
• Prospective Registration: No
• Primary sponsor: King's College London (UK)
• Public title: Control of periodontal inflammation, systemic inflammatory responses and cognitive decline in Alzheimer?'s disease
• Scientific title: Control of periodontal inflammation, systemic inflammatory responses and cognitive decline: a comparative study of standard oral care versus periodontal care
• Date of first enrolment: 22/11/2011
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN34471493
• Study type: Interventional
• Study design: Interventional randomised single-centre study (Quality of life)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Mark Ide

Key inclusion & exclusion criteria

Inclusion criteria: 1. Adults aged 70 years or older, either sex
2. Amnestic according to Consortium to Establish a Registry for Alzheimer's Disease (CERAD) cognitive battery norms
3. Mini?Mental State Examination (MMSE) score range between 24-30
4. Geriatric Depression Scale less than/equals 4/5
5. Clinical Dementia rating scale score of less than/equals 0.5
6. Participants should be nonsmoking, in good general health and English speaking in order to allow valid cognitive assessment to take place
7. Willing and able to participate in study
Exclusion criteria: 1. Less than 70 years old
2. Recent change in relevant medication
3. Current or recent smoker.
4. With 8 teeth or less
5. Not deemed sufficiently fit to undergo operative dental treatment including extractions
6. Recent active periodontal treatment
7. Reporting a history of local oropharyngeal radiotherapy resulting in oral dryness

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Periodontitis and disease progression in Alzheimer?'s disease
Nervous System Diseases
Alzheimer disease

Intervention(s)

Recruited individuals are stratified for gender and randomised into either a periodontal care or a standard care group using a random number table.

Provision of oral hygiene instruction using a Braun Oral B electric toothbrush provided for the patient and supplemented by use of chlorhexidine mouthwash for one month.

Full mouth tooth and root instrumentation under local anaesthesia over 4 visits, with tailored oral hygiene reinforcement at each visit, and where necessary, removal of hopeless teeth and removal of decay and provisional restorations in decayed teeth/repair of decayed fillings

Primary Outcome(s)

Feasiblity and effectiveness of periodontal treatment at improving oral health in people with mild cognitive impairment (primary outcome A: changes in plaque scores, probing depths and bleeding scores), measured at 6-7 weeks

Secondary Outcome(s)

1. Levels of circulating proinflammatory cytokines (CRP and IL-6)
2. Rate of cognitive decline (change in CERAD score in 6 weeks; secondary outcome B change in rate of conversion to dementia over 1 year)
3. Whether there is a shared complex inflammatory marker for periodontitis and mild cognitive impairment and whether change in this marker set predicts response to therapy (shared marker set, predictive value of marker set)

Measured at 6 months and final assessment at one year.

Source(s) of Monetary Support

NIHR Biomedical Research Centres at South London and Maudsley NHS Foundation Trust (SLaM) and Guy's and St Thomas' NHS Foundation Trust (GST) with King's College London (KCL) (UK)

Ethics review

Status:
Approval date:
Contact:

NRES Committee London - East, 05/09/2011, ref: 11/LO/0987

Results

• Results available: Yes
• Date Completed: 22/09/2016