The Effectiveness of a Home Care Ultrasonic Cleaner combined with Immersion in Peroxide-based Cleanser in the Mitigation of Respiratory Pathogens on the Dentures of Community-Dwelling Elders: A Randomised Controlled Clinical Trial

The provision of dentures is a welcome imitation of the natural dentition to achieve oral function, but it is not without limitations. A key concern is that dentures if not properly cared for can act as reservoirs for opportunistic pathogens with detrimental consequences to general health. A pilot study we conducted identified that many older people are unclear about how to care for their dentures and their denture cleanliness was poor. A Cochrane Review found insufficient and weak evidence of how best to care for dentures but recommended the combined use of mechanical and chemical cleansing methods. Mechanical cleaning of dentures is a challenge for frail elders with physical and cognitive deficits. Recently portable ultrasonic devices have become available for use at home and may offer an easy-to-use and relatively inexpensive effective alternative to conventional mechanical cleaning. A prospective, open-label, single-blind, block-randomised, cross-over, superiority-controlled clinical trial is planned. Subjects fulfilling inclusion and exclusion criteria will be (block) randomised into two treatment arms with a wash-out period of 2 weeks. Arm 1 subjects will be assigned to follow a denture care programme of ultrasonic and chemical cleaning for 3 months. Arm 2 subjects will be assigned to follow a denture care programme of non-ultrasonic (conventional mechanical cleaning) and chemical cleaning for 3 months. The primary outcome measures will be Opportunistic Respiratory Pathogenic Index scores as determined using a culture-independent, high-throughput metagenomic sequencing method of denture plaque (Type IIB Restriction-site Associated DNA Sequencing for Microbiome). The outcomes of this randomised clinical trial will provide the much-needed evidence to inform how best older adults can care for their dentures and minimise the risk of life-threatening infections.