Plain English Summary
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 March 2019
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)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Shelley Allen
ORCID ID
http://orcid.org/0000-0001-7870-740X
Contact details
Level 2
Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Type
Public
Additional contact
Miss Nicola Hellin
ORCID ID
Contact details
Bristol Dental Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
+44 (0)117 928 4314 (Dental Hospital)
dental-clinical-trials@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CT1975/RG2538
Study information
Scientific title
Feasibility study to reduce oral bacteria and improve periodontal health in those living with mild dementia
Acronym
HGHD (Healthy Gums to Help Dementia)
Study hypothesis
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
Southwest Frenchay Ethics Committee, Bristol UK, 22/01/2016, REC ref: 15/SW/0343
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
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet. Email dental-clinical-trials@bristol.ac.uk
Condition
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
Phase
Drug names
Primary 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).
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 trial start date
01/04/2016
Overall trial end date
31/03/2019
Reason abandoned
Eligibility
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
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
01/05/2016
Recruitment end date
30/04/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Bristol Dental Hospital
Bristol Dental Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
Sponsor information
Organisation
University of Bristol (UK)
Sponsor details
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 928 9000
Birgit.whitman@bristol.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Bristol Research into Alzheimer's and Care of the Elderly (BRACE) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
01/12/2019
Participant level data
Not expected to be available
Results - basic reporting
Publication summary