The study is part of a larger research project called “Brushalyze - Understanding the tooth brushing process all along: New research device for multi-sensorial detection and intelligent analysis of tooth brushing”. (Deutsche Forschungsgemeinschaft (DFG) – Project number 448034414; https://gepris.dfg.de/gepris/projekt/448034414?language=en).
Ethics & Data Privacy
In accordance with the principles of the Declaration of Helsinki, the Ethics Board of the Department of Medicine at the University of Giessen (No. 261/19) approved the study protocol. This trial is registered with the German Clinical Trials Registry (www.drks. de; DRKS-ID: DRKS00029698; date of registration: 18/07/2022). Every participant provided written informed consent. The data collection was pseudonymised (i.e. a personal code was created for each participant and the information about the person was stored under this code).
Study design, independent variable and randomisations
The study was conducted in a counterbalanced cross-over design. The independent variable was brushing with one of two test toothbrushes. All participants had two appointments in the laboratory, one week apart, during which they brushed their teeth. They were randomly assigned to one of two sequences: test toothbrush 1 at the first appointment and test toothbrush 2 at the second appointment vs. test toothbrush 2 at the first appointment and test toothbrush 1 at the second appointment. For randomisation, boxes were set up for female and male participants, each containing ten identical opaque containers each filled with a slip of paper indicating group allocation. The boxes were filled until the calculated sample size was reached. While the participant was undergoing the first clinical examination (see the section "procedures"), the examiner responsible for the assessment of the behaviour (CB) phoned an assistant not involved in the study and informed about the participant's sex. The assistant blindly pulled a container jar out of the respective box, opened it and told CB the group membership (group 1 or group 2).
The following toothbrushes were used:
Test toothbrush 1 – Brushalyze-V1 (BV1). This toothbrush consists of a handle similar to that of an powered toothbrush. The handle is prepared for commercially available brush heads as used in sonic toothbrushes. The brush head used for current analysis has a flat bristle field 1. The bristles are arranged in an elliptical shape (see Fig. 1; for more details regarding the handle and its function within the Brushalyze project see Appendix).
Test toothbrush 2 – Commercial manual toothbrush (MT). The second tooth brush is a commercial brush with a brush head similar to that of the BV1 (see Fig. 1).2 In a pre-test, six members of the research team (2 dental and 4 non-dental) independently compared the shape and haptics of the bristle field of several commercial manual toothbrushes3 with that of the BV1 (see Fig. 1). They all voted for the selected brush as the one that most closely resembled the BV1 in this respect.
Participants
Participants were N = 50 students and employees of the Justus-Liebig-University of Giessen (Germany) who habitually brushed their teeth by a manual tooth brush (2/3 of tooth brushing events per week or more). They were recruited via a mailing that informed about the topic (toothbrushing), the basic procedure of the study and the financial compensation (30 €). Participants were eligible if they were 18 ̶ 35 years old, had at least 20 natural teeth and a very good proficiency in German. In order to avoid participants bias, the following exclusion criteria were applied: training with a dental background; braces, fixed retainers, removable dentures; oral piercing or dental jewellery; pregnancy and breastfeeding; cognitive and physical limitations when brushing teeth (e.g. due to arm injury); professional tooth cleaning or tooth polishing in the past 4 weeks; acute or chronic diseases affecting the oral cavity (e.g. diabetes, HIV, eating disorders, herpes); medication for epilepsy, heart disease or immunosuppression; former participation in a tooth-brushing study of the institute.
Procedures
The examinations took place between August and September 2022 at the Institute of Medical Psychology, Justus-Liebig-University of Giessen. To ensure the safety of the participants and the personnel (CB and NB), all persons involved in the study performed a rapid SARS-CoV-2 antigen test on all examination days. All experimenters interacted with the participants in a fully standardised manner by using always the same words and explanations. They were not allowed to talk to each other about the test persons and the observations they had made about them.
First appointment
CB welcomed the participants and informed them in detail about the study procedure but kept them blind with regard to the precise research hypotheses. The participants read through the study consent form and then gave their written consent. Afterwards they went to the dental examination room where NB assessed the number of missing teeth, the papillary bleeding and dental status (DMF-T) of the participants. Then they entered an observation lab equipped with remote cameras and an intercom. There CB had prepared the randomly assigned condition (brushing with BV1 or MT). CB placed the participants in front of a washbasin and a tablet computer with a front-facing camera. With its camera, the tablet served as a mirror for the participants and it also allowed the toothbrushing procedure to be recorded. Two other cameras in the corners of the room served as back-up. Prior to brushing with the BV1 participants were asked to move the brush once along the upper jaw from the left posterior molar to the right posterior molar. They also were individually fitted with a head frame equipped with magnets. These procedures served other features of the Brushalyze project described in detail in the Appendix. Apart from these special features, the rest of the process was exactly the same for both brushes. Toothpaste (Meridol, CP GABA, Hamburg, Germany), a water cup and water were provided. Participants were asked to brush to the best of their abilities (“Please brush your teeth as good as you can, so that they are completely clean”) with their assigned toothbrush and without a time limit. Video recording was started and participants were left alone. Immediately after brushing, participants underwent sham staining and sham assessment of plaque (sham rather than real staining was necessary to avoid visible staining influencing behaviour at the second visit). Finally, participants were asked to answer some questions on the tablet. First, they had to assess their self-perceived oral cleanliness by a visual analogue scale ranging from not at all clean to totally clean (SPOCn, [25]). Then, questions were presented about the toothbrush they had just used compared to the one they used at home in terms of handling, stiffness of the bristles and weight, and finally, age and gender were asked.
Second appointment (one week later): CB welcomed the participant and NB assessed papillary bleeding. Then they were asked to brush their teeth in exact the same manner like in the first session. But now participants brushed with the other brush. Immediately after brushing, plaque was assessed. The final task was again a tablet survey: The questionnaire started identically to the questionnaire of the first appointment (i.e. the assessment of the SPOCn and the comparison of the toothbrush just used to the usual toothbrush). Then the participants had to compare the toothbrush they had just used with the toothbrush used at the first appointment (again in terms of handling, bristle stiffness and weight). Subsequently, the participants answered in more detail the self-perceived cleanliness after they had been informed about the way a dentist would assess it (SPOCd, [25]). The questionnaire ended with some open questions about the BV1, in which positive and negative aspects of the toothbrush itself and the head frame were to be mentioned.
Behavioural outcomes: observed toothbrushing
Video anlayses were performed as decribed before by use of the software Mangold INTERACT® 18 and previously validated observation procedures (Mangold International, Arnsdorf, Germany) [26, 27]. Briefly, calibrated examiners (PE, TS and NB) assessed the tooth contact time (time during which the toothbrush touches the teeth, without interruptions such as spitting, rinsing, etc.), the surface (occlusal, inner, outer) brushed within this time and the brushing movements (a.o., horizontal, vertical, circular) that were carried out. The primary outcome variable was percentage tooth contact time on inner surfaces. Secondary outcomes were percentage tooth contact time on outer and on occlusal surfaces and percentage tooth contact time with circular and with vertical movements (28;29). Calibration began with written and oral instructions regarding the observation categories and the use of the observation software. Then, the examiners analysed sample videos from previous studies. The calibration criterion was an intra class correlation of ICCs ≥ 0.90 between the observer and the previous annotations for at least five consecutive videos. If the criterion was missed, the observer was reinstructed and analysed additional videos until the criterion was reached. To assess the quality of annotations after calibration, 10 videos were randomly selected for each behavioural category and double-anotated by another calibrated examiner (WP, TS); the agreement between the observers was excellent (all ICCs ≥ 0.90). All examiners besides NB were fully blinded regarding the clinical or questionnaire data. NB performed the annotation several weeks after the assessment of the clinical data (November 2022 ─ April 2023), in order to minimise bias due to knowledge of the clinical data.
Clinical data
Clinical assessments were performed by a calibrated dentist (NB) who was blinded with respect to the participants' group membership, their oral hygiene behaviour and the questionnaire data. The calibration procedure was similar to previous studies [28, 30]: An experienced calibrated dentist (WP) instructed NB. Afterwards both assessed the same individuals independently. They did not reveal their scores until they had both finished with an individual. Calibration was considered successful if, for five consecutive individuals, at least 90% of the ratings were identical and the remainder differed by no more than one point.
A simplified version of the papillary bleeding index (PBI, 31) was assessed to control for gingival health. Only the presence or absence of papillary bleeding was assessed. These parameters were assessed on all present teeth (including the third molars).
The DMFT-Index was assessed at the first clinical examination of the first appointment. Third molars were not included into that assessment in order to comply with the principles of the World Health Organisation [32].To test whether the handle affected plaque persistence plaque levels were assessed at the second appointment immediately after brushing after staining (Miradent Mira-2-Ton®; Miradent, Germany). The primary clinical outcome for this analysis was the Marginal Plaque Index (MPI, [33]); the MPI assesses whether plaque is present (= 1) or absent (= 0) at eight equally sized sections at the gingival margin (four each at the inner/outer gingival margin). As an additional parameter the more coronal parts of the crown as indicated by the percentage of scores 3–5 of the Turesky modification of the Quigley and Hein Index (TQHI, [34]) were assessed; score 3 describes a plaque band wider than 1 mm but covering less than 1/3 of the crown, score 4 plaque covering at least 1/3 but less than 2/3 of the crown and score 5 plaque covering at least two-thirds of the crown.
Subjective evaluation of the brush
Within the current analysis the subjective evaluations of the brushes serve as a manipulation check. At the end of each appointment the participants answered Likert scales to evaluate the handling and the nature of the brush they just had used in comparison to the one they use at home. At the end of the second appointment they also answered items directly comparing both brushes (the questions of these questionnaires are shown in the Appendix). Additionally, self-perceived oral cleanliness (SPOC) was assessed by a validated questionnaire [25]. Participants provided their naïve SPOC-estimation (SPOCn) after both appointments and their SPOC-estimation according to the standards of a dentist (SPOCd) after the second appointment only. For assessment of SPOCd participants receive information how the MPI is assessed. Afterwards they estimate in 12 regions how many sections would be free of plaque. This is summarised in a score that can be read as an inverted MPI, as it indicates the percentage of (self-perceived) cleanliness rather than the percentage of plaque. The primary outcome regarding handling was the direct comparison of the two brushes regarding handling. The secondary outcome was SPOCd and SPOCn and the indirect comparison of the handling (i.e. the comparison of the evaluations with respect to the tooth brush used at home). The primary outcome regarding the nature of the brush was the direct comparison of the bristle stiffness, the secondary outcome was the indirect comparison of bristle stiffness and the direct comparison of the weight.
Statistics
The research hypothesis stated that the brush would influence the extent to which certain behavioural parameters are displayed, but not the position of the person in the group. It was thus expected that the means would differ, but that the correlations between repeated measures would be high. Correlations (r) are interpreted in analogy to Guilford [35]: a high correlation and marked relationship lies between |.70| and |.90|, correlations above |.90| are described as very high and as a very dependent relationship. According to Cohen [36], standardized mean differences (SMD) of d ≥|.2| |.5| |.8| are considered small, medium and large, respectively. This was translated into the following statistical hypotheses pairs: H0: µBV1 = µMT; H1: µBV1 ≠ µMT and H0: ρBV1,MT ≤ 0.5; H1: ρBV1,MT > 0.5. Power calculation with G*Power [37] indicated that a sample size of 50 would allow for the detection of small to medium SMD and correlations of ρ > 0.72 with alpha = 0.05 and a power of 1 - β = 0.80.
Statistical procedures were performed using IBM SPSS Statistics, Version 29.0 (IBM SPSS Statistics for Windows; IBM, Armonk, New York, USA). Correlations are reported as Pearson and as Spearman correlations since single outlying values can distort results of Pearson correlations; 95% confidence intervals (95% CI) are reported along with Pearson correlations. T-Tests for dependent variables are computed to test for equality of the means of repeated measures. For behavioral analysis additional Wilcoxon tests are computed to control for distortions due to outlying values. T-tests for independent variables are used to compare baseline values and the means of variables assessed at the second appointment, only (plaque, SPOCd).