Improvement of oral hygiene for the prevention of intraoral diseases such as dental caries and periodontitis.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Capacity to provide informed consent; sufficient German language proficiency; willingness to attend three study visits (each = 7 days apart)
Exclusion criteria
Exclusion criteria: Complete dentures; acute periodontitis or acute pain conditions; regular use of U-shaped automatic toothbrushes within the past 2 months; severe hand or arm impairments that make handling a toothbrush impossible; lack of capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the present study is to determine the effectiveness of a U-shaped automatic toothbrush in older adults with regard to plaque removal. Specifically, the study aims to quantify the amount of dental plaque removed through the use of this device. This primary objective also includes a comparison with the conventional toothbrushing method. We seek to determine whether the U-shaped automatic toothbrush achieves, on average, an equivalent, superior, or inferior reduction in plaque compared with standard manual toothbrushing in this population. In doing so, this study will, for the first time in the population of older adults, examine whether such a device could represent a viable alternative to the conventional manual toothbrush. | — |
Secondary
| Measure | Time frame |
|---|---|
| Influence of cognitive performance: The study will investigate whether the cognitive performance of the participants influences the outcome of plaque removal. In other words, do participants with better cognitive function (e.g., intact memory and good executive functioning) achieve more effective plaque removal with the U-shaped toothbrush than participants with mild cognitive impairments? This objective also includes comparing the influence of cognition between the brushing methods. Specifically, we aim to evaluate whether cognitive differences have a stronger or weaker impact on brushing outcomes during manual toothbrushing compared with the automatic toothbrush. Influence of hand strength/hand motor function: Similarly, hand strength (as an indicator of the physical ability to handle the toothbrush) will be examined to determine whether it exerts a moderating effect on plaque removal. We hypothesize that reduced hand and finger strength or limited dexterity may substantially impair the outcome of manual toothbrushing. In contrast, the influence may be smaller when using the U-shaped toothbrush, as fewer active brushing movements are required. This objective therefore examines the extent to which the new device is less dependent on the user’s physical dexterity. Subjective evaluation and acceptance: Another secondary objective is to assess the participants’ subjective experiences and satisfaction with the U-shaped automatic toothbrush compared with their usual oral hygiene practices. This includes, for example, the perceived cleanliness of the mouth after use (subjective feeling of freshness assessed using a visual analog scale), as well as user-friendliness and willingness to use such a device regularly. These subjective endpoints provide context for the objective plaque data and help evaluate whether older adults would practically accept this new method. Safety and side effects: As an additional secondary objective, the occurrence of any adverse effect | — |
Countries
Germany
Contacts
Poliklinik für Zahnärztliche Prothetik, Propädeutik und Werkstoffwissenschaften und Abteilung für Oralmedizinische Technologie, Universitätsklinikum Bonn