Control of periodontal inflammation, systemic inflammatory responses and cognitive decline in Alzheimer's disease
| ISRCTN | ISRCTN34471493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34471493 |
| Secondary identifying numbers | 1 |
- Submission date
- 03/05/2013
- Registration date
- 16/08/2013
- Last edited
- 22/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
An important cause of inflammation (soreness and swelling), especially in older people, is gum disease. This can be treated by improving oral health dentists can fix damaged teeth and dental hygienists can help to keep the gums healthy by cleaning and by providing advice. Some evidence suggests that inflammation is also important in Alzheimer's disease. This inflammation, both that caused by gum disease and that associated with Alzheimer's, can be measured in the blood. This study aims to find out if people with mild memory problems have inflammation that can be measured in their blood and whether improving gum health reduces that inflammation. If it does, then the next step, in another study, would be to see whether this affects the risk of getting Alzheimer's disease.
Who can participate?
People over the age of 65 who do not have dementia but do have some memory problems
What does the study involve?
People taking part in the study are randomly allocated to two groups: one receives an intensive dental treatment and the other receives usual care. They have an assessment of their memory and a blood and saliva test. Then they see a dentist and a dental hygienist. Some have regular treatment fixing any major problems with their teeth and advice about how to keep the gums healthy. Others have more intensive dental hygiene.
What are the possible benefits and risks of participating?
The possible benefits are a good assessment of tooth and gum health for all participants followed by either normal standard of care or more intensive oral health treatment. The risks are nothing more than that of having a blood test.
Where is the study run from?
This is a study at King's Health Partners, a group of hospitals including the Maudsley, King's College and Guys and St Thomas', London (UK)
When is the study starting and how long is it expected to run for?
November 2011 to November 2014
Who is funding the study?
The Biomedical Research Centres at King's Health Partners (UK)
Who is the main contact?
Professor Simon Lovestone
Simon.Lovestone@kcl.ac.uk
Contact information
Scientific
Dental Institute
King's College London
Periodontology Floor 21 Tower Wing
Guys Hospital
Great Maze Pond
London Bridge
London
SE1 9RT
United Kingdom
 ORCID ID |
0000-0002-6511-7803 |
|---|---|
| Phone | +44 (0)20 7188 5391 |
| mark.ide@kcl.ac.uk |
Study information
| Study design | Interventional randomised single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Control of periodontal inflammation, systemic inflammatory responses and cognitive decline: a comparative study of standard oral care versus periodontal care |
| Study objectives | 1. To investigate relationships between periodontal disease (and associated systemic inflammatory responses) and both progression of cognitive decline and gene expression in T cells and dendritic cells in response to such inflammatory changes. 2. To determine the feasibility of a hub and spoke-based community assessment of oral and mental health, and secondary care provision of dental treatment, for the improvement of oral health and changes in systemic markers of inflammation as a precursor to a larger intervention study to determine how this influences cognitive decline, mediated by and related to changes in lymphocyte activity. |
| Ethics approval(s) | NRES Committee London - East, 05/09/2011, ref: 11/LO/0987 |
| Health condition(s) or problem(s) studied | Periodontitis and disease progression in Alzheimer's disease |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 22/11/2011 |
| Completion date | 22/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 60 |
| Key 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. MiniMental 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 |
| Key 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 |
| Date of first enrolment | 22/11/2011 |
| Date of final enrolment | 22/11/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 9RT
United Kingdom
Sponsor information
University/education
c/o Keith Brennan
Hodgkin Building
St Thomas Street
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)20 7848 6960 |
|---|---|
| keith.brennan@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/ |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 12/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
22/03/2018: The intention to publish date was changed from 22/09/2017 to 12/03/2019.
09/01/2017: The overall trial end date was changed from 22/11/2014 to 22/09/2016.
