Methods
ABI, ®
CAVITY, PLAQUE
A pilot study was designed as a randomized, controlled clinical trial and conducted between June and November 2022. A Balene® manual toothbrush was employed for half of the participants during the first appointment; as a control, a conventional manual toothbrush was employed during the second appointment (after a 2-week washout period). The order of the toothbrush implementation was reversed for the other half of the participants. To remove interparticipant variability from the intergroup comparisons, a crossover design was employed in which each participant served as their own control. To determine whether a participant should use the Balene® manual toothbrush or the conventional manual toothbrush during the first appointment, a system of randomization in balanced blocks (using numbered containers) was employed.The study’s protocol was approved by the Ethics Committee of the University of Santiago de Compostela, Spain (registration number 2021/27). The participants, or their legal guardians (if necessary), completed and signed a specific informed consent for study participation. This article was prepared following the standards established for the presentation of information of trials (Consolidated Standards of Reporting Trials [CONSORT]) [The inclusion criteria were an age greater than 18 years, confirmed diagnosis of ABI, and voluntary participation by signing an informed consent (either the patient or their legal representative). The following exclusion criteria were established: failure to provide a minimum of cooperation in allowing the toothbrushing to be performed, failure to achieve a mouth opening sufficient for performing the toothbrushing, not having at least one molar or premolar in each quadrant, and not having at least one maxillary incisor/canine and another mandibular incisor/canine.Applying these criteria, 7 of the 32 users of the center were excluded, 3 for carrying a complete dental prosthesis, 3 for carrying a considerable fixed prosthesis (with more than 4 crowns), and 1 who was unable to sufficiently open their mouth. The pilot study’s participants consisted of 25 adults with ABI (12 men and 13 women between the ages of 41 and 74 years) who were members of the Alento Association for Individuals with ABI (Vigo, Spain). While 9 (36%) of the participants could perform autonomous toothbrushing, the remaining 16 (64%) required assistance to perform the toothbrushing. In 10 individuals (5 able to autonomously toothbrush and 5 requiring assistance), toothbrushing with the classical manual toothbrush was not performed due to a scheduling conflict with another activity in the center (6 participants), due to hospitalization (2 cases), or due to the expressed desire not to continue (2 cases). In this study, each participant used their preferred standard toothpaste (e.g., patients unable to spit out employed toothpaste without foaming agents). The supervision of the autonomous brushing and the performance of the assisted brushing were conducted by the regular caregivers of the Alento Association. With the objective of instructing the caregivers and patients with ABI on the toothbrushing technique with the Balene® toothbrush, the study’s authors conducted an information session lasting approximately 1 h, in which an informational video was projected and a direct demonstration conducted of the autonomous and assisted toothbrushing modalities.The manual Balene® toothbrush is characterized by two heads with 6 active sides, which allows for the simultaneous brushing of both the inner and outer sides of the upper and lower dental arcades. Its elastomer (thermoplastic polyurethane) bristles are angled at 45°, and its handle rotates up to 180°. The toothbrush does not therefore need to be removed from the oral cavity to change quadrant during toothbrushing (Fig. The new double-headed, 6-sided Balene® toothbrush with rotating handleThe participants’ teeth should not have been brushed in the 24 h prior to the appointment. Before starting each toothbrushing session, a plaque-disclosing agent (Plac control®, Dentaid, Barcelona, Spain) was applied with a mini-brush (Microbrush®, Dental Iberica, Mieres-Siero, Spain) to the dental surface of the teeth included in the simplified oral hygiene index of Greene and Vermillion [This study considered independent variables the type of toothbrush (Balene® vs. conventional) and the toothbrushing modality (assisted vs. autonomous). The dependent variable was the quantification of the removed plaque. Two hypothesis tests were employed to perform the statistical analysis: the Wilcoxon signed-rank test and the Mann–Whitney U (Wilcoxon rank sum) test.