Extract

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 ([email protected])

Inclusion criteria

• Periodontitis (gum disease) in people living with mild dementia

Links

• isrctn