Condition category
Oral Health
Date applied
11/05/2016
Date assigned
27/05/2016
Last edited
27/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.bristol.ac.uk/

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

Publication citations

Additional files

Editorial Notes