The OrBiD (Oral Health, Bite Force and Dementia) Pilot Study: A Study Protocol for New Approaches to Masticatory Muscle Training and Efficient Recruitment for Longitudinal Studies in People with Dementia.

Research with people with dementia is a great challenge in terms of recruitment, study participation and adherence to interventions resulting in less research activity and higher financial, organizational and personnel efforts. As dementia progresses, there is a deterioration in general and oral health and chewing function. Oral treatment options often focus on healthy patients. Interventions for people with dementia are needed. The aims of the paper were to describe the study protocol of the OrBiD (Oral Health, Bite Force and Dementia) pilot study as well as the description of two new methodological approaches. These are (A) an efficient recruitment process of people with dementia, simultaneous double study participation and (B) a novel approach to train the masticatory muscles by using physiotherapy. A novel methodology for the recruitment process (A) and, in particular, for the assignment of subjects to the experimental and control groups was developed and successfully tested. Additionally, a physiotherapy program (B) to train strength and coordination of the masticatory muscles was newly developed with the challenge to ensure that this training could also be carried out with people with cognitive impairments and dementia, if necessary, in cooperation with their relatives or caregivers. This was also successfully implemented. Recommendations for a feasibility assessment of a study involving people with dementia were made considering the organizational effort, the required personnel, structural and financial resources, the required number of subjects and the type of study design. When planning crossed studies, it must be ensured that the content, the interventions or their possible results of the study arms do not influence each other. The overall aim of this paper is to demonstrate the sustainable and efficient feasibility of studies with people with dementia.