Reducing oral bacteria in those with mild dementia
| ISRCTN | ISRCTN74980794 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74980794 |
| Secondary identifying numbers | CT1975/RG2538 |
- Submission date
- 11/05/2016
- Registration date
- 27/05/2016
- Last edited
- 19/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The aim of this study is to see whether we can improve the oral health of people with gum disease (periodontitis) who are in the early stages of dementia. If we can show that it is possible to do that then we can apply for more funding for a larger study.
Who can participate?
Patients with mild dementia and gum disease
What does the study involve?
All patients follow a routine programme designed to reduce dental plaque and oral bacteria levels over a 2 year period. We hope to collect information on patient compliance, drop-out rate, and the success of the treatment. We measure the improvement in the patients’ gum health and also any change in cognition. The patient’s carer/friend is asked to support the patient, including reminding and aiding the patient in appointment attendances, home-care routine and compliance.
What are the possible benefits and risks of participating?
Participants may benefit from improved periodontal health, which should reduce dental discomfort and future tooth loss. We are hoping that this may also reduce the rate of cognitive decline. Participants will be asked to attend the dental hospital on a number of occasions. This will be fully explained to them during the informed consent process and some money is available to cover travel expenses. Antibiotics may be used to treat periodontitis if necessary but will only be prescribed where there is a clear indication. As with use of any antibiotics, there may be a risk of Clostridium difficile associated disease. This will be discussed and participants and project partners will be informed about possible symptoms and advised how to access medical care if necessary. Plaque control agents used in the protocols are commercially available. If any side effects occur a suitable mouthwash alternative will be sourced for the participant to use. A routine dental examination including X-rays has good clinical justification and would be required for dental diagnosis and treatment planning. All X-ray exposures will be kept as low as reasonably practicable.
Where is the study run from?
The University of Bristol Dental Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2016 to February 2020
Who is funding the study?
Bristol Research into Alzheimer's and Care of the Elderly (BRACE) (UK)
Who is the main contact?
1. Dr Shelley Allen
2. Nicola Hellin (dental-clinical-trials@bristol.ac.uk)
3. Maria Davies (Maria.Davies@bristol.ac.uk)
Contact information
Scientific
Level 2
Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0001-7870-740X |
|---|
Public
Bristol Dental Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
| Phone | +44 (0)117 928 4314 (Dental Hospital) |
|---|---|
| dental-clinical-trials@bristol.ac.uk |
Scientific
Clinical Trials Unit
Bristol Dental School and Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
| Phone | +44 (0)117 342 9503 |
|---|---|
| Maria.Davies@bristol.ac.uk |
Study information
| Study design | Interventional single-centre open study with no controls |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Open feasibility study with no placebo and no controls |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. Email dental-clinical-trials@bristol.ac.uk |
| Scientific title | Feasibility study to reduce oral bacteria and improve periodontal health in those living with mild dementia |
| Study acronym | HGHD (Healthy Gums to Help Dementia) |
| Study objectives | We hypothesise that, by compliance with a professional and homecare routine designed to improve periodontal health, patients with mild/early dementia will be able to reduce their number of pathogenic oral bacteria during the course of this study. |
| Ethics approval(s) | Southwest Frenchay Ethics Committee, Bristol UK, 22/01/2016, REC ref: 15/SW/0343 |
| Health condition(s) or problem(s) studied | Periodontitis (gum disease) in people living with mild dementia |
| Intervention | 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 |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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) |
| Overall study start date | 01/04/2016 |
| Completion date | 05/02/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 18 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/07/2016 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
Sponsor information
University/education
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Phone | +44 (0)117 928 9000 |
|---|---|
| Birgit.whitman@bristol.ac.uk | |
| Website | http://www.bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | We hope that any trial data will have been assessed by June 2019. Participants are invited to contact us if they want to know any general results of the trial. |
| IPD sharing plan | The microbial datasets generated and/or analysed during the current study will be included in the subsequent results publication. Other data generated during the current study are not expected to be made available as participants were not asked to consent for the sharing of their data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 6 | 28/06/2017 | 08/06/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 16/09/2024 | 19/09/2024 | Yes | No |
Additional files
Editorial Notes
19/09/2024: Publication reference added.
11/12/2023: The intention to publish date has been changed from 31/12/2023 to 30/04/2024.
15/11/2023: The recruitment start date was changed from 01/05/2016 to 27/07/2016.
09/06/2023: The intention to publish date has been changed from 30/06/2023 to 31/12/2023.
08/06/2023: Uploaded protocol (not peer-reviewed) as an additional file.
14/06/2022: The intention to publish date has been changed from 30/06/2022 to 30/06/2023.
05/01/2022: The intention to publish date has been changed from 21/12/2021 to 30/06/2022.
23/03/2021: IPD sharing statement added.
17/03/2021: The following changes were made to the trial record:
1. Contact details updated.
2. Total final enrolment added.
3. The overall trial end date was changed from 31/12/2021 to 05/02/2020.
05/05/2020: The intention to publish date was changed from 01/12/2019 to 21/12/2021.
29/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2017 to 31/12/2018.
2. The overall end date was changed from 31/03/2019 to 31/12/2021.
3. Dr B Warnes was added as a scientific contact.
4. The inclusion criteria were changed.
4. The plain English summary was updated to reflect these changes.
