Raquel Lopes dos Santos,Manuela da Silva Spinola,Ellen Carvalho,Denis Clay Lopes dos Santos,Naile Dame-Teixeira,Debora Heller
Effectiveness of a New App in Improving Oral Hygiene in Orthodontic Patients: A Pilot Study
Orthodontic appliances,Mobile applications,Biofilm,Oral hygiene
Objectives The aim of this randomised clinical trial was to evaluate the effects of a mobile application (app) on the oral hygiene (OH) of adolescents undergoing fixed orthodontic treatment. Methods Eight volunteers (14–19 years old) were randomly allocated to the experimental or control groups. Volunteers in the control group received standard OH (SOH) instructions, whilst volunteers in the experimental group received SHO + OH guidance and motivation through an app tailor-made for this study. Clinical assessments were made using the visible plaque index (VPI) and gingival bleeding index (GBI) at 5 different time points: before orthodontic device installation (T0); at baseline (T1); and 30 (T2), 60 (T3), and 90 (T4) days after randomisation. Significant differences were evaluated using Student t test and multilevel logistic regression analysis. Results Although no significant difference could be observed, VPI at T1 and T2 were lower for volunteers in the experimental group (33.20 ± 19.29; 32.10 ± 7.72) than for the volunteers in the control group (42.11 ± 8.56; 43.59 ± 34.71). The same was observed for GBI, in which volunteers in the experimental group presented lower GBI at T1 and T2 (12.70 ± 8.10; 13.72 ± 7.39) than volunteers in the control group (27.53 ± 17.89; 20.38 ± 9.95). Good acceptance for using the app was shown by volunteers. Conclusions This study shows the potential utility of the mobile app for improving the OH of adolescents.
Effectiveness of a New App in Improving Oral Hygiene in Orthodontic Patients: A Pilot Study

The aim of this randomised clinical trial was to evaluate the effects of a mobile application (app) on the oral hygiene (OH) of adolescents undergoing fixed orthodontic treatment.

Eight volunteers (14–19 years old) were randomly allocated to the experimental or control groups. Volunteers in the control group received standard OH (SOH) instructions, whilst volunteers in the experimental group received SHO + OH guidance and motivation through an app tailor-made for this study. Clinical assessments were made using the visible plaque index (VPI) and gingival bleeding index (GBI) at 5 different time points: before orthodontic device installation (T0); at baseline (T1); and 30 (T2), 60 (T3), and 90 (T4) days after randomisation. Significant differences were evaluated using Student t test and multilevel logistic regression analysis.

Although no significant difference could be observed, VPI at T1 and T2 were lower for volunteers in the experimental group (33.20 ± 19.29; 32.10 ± 7.72) than for the volunteers in the control group (42.11 ± 8.56; 43.59 ± 34.71). The same was observed for GBI, in which volunteers in the experimental group presented lower GBI at T1 and T2 (12.70 ± 8.10; 13.72 ± 7.39) than volunteers in the control group (27.53 ± 17.89; 20.38 ± 9.95). Good acceptance for using the app was shown by volunteers.

This study shows the potential utility of the mobile app for improving the OH of adolescents.

Despite its numerous benefits, orthodontic treatment is commonly associated with an increased risk of periodontal diseases and caries. The increase in biofilm retention areas with orthodontic appliances can lead to an increased prevalence of dental biofilm-dependent diseases, as it hinders oral hygiene (OH) practices. Whilst there has been a great advancement of preventive dentistry in the last decades, dental caries still affects a very high number (up to 96%) of orthodontic patients.4, 5, 6, 7 Dental biofilm control is essential for the prevention and treatment of this disease and can be performed through mechanical procedures to disrupt the biofilm with and without the adjunct use of antimicrobial products. Successful orthodontic treatment occurs when the correction of the occlusion is achieved without altering the preexisting health status of the teeth and supporting tissues. Thus, it is important to use educational and preventive approaches before and during treatment. It has been observed that an educational approach directed at young people, using playful language, is more effective, especially when using images and tools such as smartphones and tablets, thus representing a promising new tool to reach this population. As the use of interactive resources is already part of the daily life of children and adolescents, these digital media can be an alternative to teach oral health to these patients. Currently, two-thirds of the world population has their own smartphone, and the use of application technology to help health care professionals and patients has increased, affecting all areas of patient care. This advancement in digital technology plays a positive role in modifying beneficial health behaviours. Thus, we developed a mobile application (“A Dentista Cientista”) designed to improve OH and therefore prevent diseases whose biofilm accumulation is necessary—dental caries and periodontal diseases—during the fixed orthodontic treatment of adolescents. Here we report the results of a randomised controlled clinical trial to scientifically verify the effectiveness of this application. The main objective of this study was to evaluate the effects of a motivational method made by a cell phone application to improve OH in patients undergoing orthodontic treatment.

This study followed the CONSORT statement for randomised clinical trials and was approved by the Human Research Ethics Committee of Universidade Cruzeiro do Sul (process number: 2.879.284) and registered at Plataforma Brasil (CAAE: 90378318.4.00008084) and at the Brazilian Registry of Clinical Trials REBEC (UTN number: U1111-1234-9378).

Eight volunteers, aging from 14 to 19 years old, who started fixed orthodontic treatment using the direct bonding technique with Roth-Max slot 0.018 prescription brackets at the Orthodontics Clinic at Universidade Cruzeiro do Sul, São Paulo, Brazil, were invited to participate in the study. Volunteers’ guardians had to read, understand, and sign the informed consent term. The study was then explained to the volunteers using appropriate language through the term of assent.

Inclusion criteria were as follows: age between 14 and 19 years old, having a smartphone, and having treatment with a fixed orthodontic appliance and exclusive presence of permanent dentition. Volunteers who had previous orthodontic treatment, presence of any oral pathology, and chronic use of analgesic medication or presence of syndromes were excluded from the study.

Before the beginning of the study, an intra-examiner calibration of the researcher (RL) was performed. The calibration involved examining individuals with clinical conditions similar to those of the individuals included in the study: patients without braces and patients with fixed orthodontic braces. Visible plaque index (VPI) was assessed on individuals, with a 1-hour interval between them. The examiner's intraclass correlation coefficient was >0.90.

Patients were assigned consecutive and ascending numbers at the enrolment visit. Immediately after orthodontic device installation, each patient was randomised to a single group (app or control) by using the method of randomly permuted blocks. The allocation was implemented by a senior investigator (EC) who was not directly involved in the examination or treatment procedures. Identification codes were kept concealed from all individuals directly involved in the study until statistical analyses were carried out.

Volunteers in both groups were assessed for OH using the VPI and the gingival bleeding index (GBI) at 6 sites of all teeth in every arch excluding third molars. Clinical evaluations were performed before orthodontic device installation (T0); at baseline (immediately after randomisation) (T1); and 30 (T2), 60 (T3), and 90 (T4) days after the beginning of the intervention. Previous to the intervention, all patients who participated at the recruitment underwent an oral hygiene session designed to obtain a plaque index equal to zero and received standardised OH instructions (Figure 1). Volunteers allocated to the control group did not receive any structured OH follow-up in addition to the standard follow-up already established at the Orthodontic Clinic. Participants in the experimental group were guided by a member of the study, the same one who did the randomisation draw (EC), to download the app created exclusively for this research “A Dentista Cientista.” All investigators, including the examiner, orthodontist, and statistician, were blinded. This app aimed to guide and motivate volunteers daily in a playful way about performing OH practices (more information available at supplemental material 1S-5S). After the registration in the app, volunteers were instructed to set a schedule of their daily activities (ie, waking, breakfast, lunch, dinner, and bedtime), in which they were reminded to perform their OH through an alarm. These alerts were included in the general calendar of volunteers’ cell phones. In addition, every week EC contacted the volunteers in the experimental group to answer any question they may have. In this contact, volunteers were asked to send screenshots of the app's calendar screens to monitor usage.

At the end of the study, a structured questionnaire was applied to identify the profile of the volunteers who used the app and to analyse their opinions about it.

Data were analysed using Stata/SE 13.0 software. The chi-square test (for sex − nominal variable) and Student t test (for age − quantitative variable) were used to assess the distributions between the variables analysed (experimental and control groups). For the assessment of the outcomes, presence of plaque and gingival bleeding between groups, multilevel logistic regression analysis (patient cluster) was used and the number of evaluated surfaces (1338) was used as the unit of measurement. All variables independent of P < .20 in the univariate logistic regression were taken to the adjusted analysis. The Kolmogorov–Smirnov normality test for GBI and VPI was performed for each evaluation moment (T0–T4). For comparison between groups, Student t test was used, and to compare the evaluation times for dependent samples, paired samples t test was used. The level of significance for all the tests was set at 5%.

A total of 11 patients were screened for study eligibility, and 2 patients were excluded (1 patient for previous orthodontic treatment and 1 patient for having a syndrome). At T2 before randomisation, one patient missed his appointment and was excluded. Eight patients were distributed into experimental and control groups (Figure 2). There was no statistical difference between age and sex distribution between the groups (P > .05; Table 1). There was no significant statistical difference for VPI and GBI between the groups at any time evaluated (P > .05). However, we could observe that at T1 and T2, volunteers in the experimental group presented a tendency for lower VPI and GBI than the volunteers in the control group (Table 2). When the unit of measurement used was the patient, the percentage of visible plaque (Figure 3A) and the percentage of gingival bleeding (Figure 3B) between the groups at the different evaluated times could be observed. At T0, before placing the device, none of the variables evaluated were associated with the presence of plaque (group, region, arch, and surface). At T1, immediately after installation of the device but before randomisation, a significantly greater accumulation of plaque was observed in the lower arch when compared to the upper arch (P = .027). A greater accumulation with statistical significance was also observed on the vestibular surface when compared to the lingual (P = .023) and proximal (P < .001) surfaces. After 30 days of randomisation and use of the app at T2, the lower arch continued with a higher plaque index with statistical difference compared to the upper one (P < .001). At T3, the result is observed after 2 months of randomisation: The percentage of plaque in the posterior region was significantly lower when compared to the anterior region (P = .023), and the lower arch presented a higher percentage of plaque when compared to the upper region (P = .010). However, there was no difference between groups (P = .65) or between lingual (P = .092) and proximal (P = .153) surfaces. At T4, it was observed that the anterior (P < .001) and lower (P = .009) regions continued to have a greater accumulation of plaque with statistical significance compared to the posterior and upper arch regions, respectively. The percentage of plaque between the surfaces was different, with the vestibular region showing a higher index than the lingual (P = .017) and proximal (P = .009) surfaces (available in Tables 1S–5S in the supplementary information). There was no statistical difference between the experimental and control groups regarding the outcome of gingival bleeding at the evaluated times (T0–T4; available in Tables 6S–10S in the supplementary information). At T0, regarding the outcome of gingival bleeding, there was no difference in any of the variables evaluated: posterior region (P = .849), lower arch (P = .417), and between lingual (P = .254) and proximal (P = .584) faces. At T1, immediately after device installation, the percentage of gingival bleeding increased in the lower arch when compared to the upper arch (P = .041). The buccal surface showed a higher percentage of gingival bleeding compared to the proximal surfaces (P < .001). After 30 days of randomisation, at T2, the vestibular surface showed greater bleeding than the proximal ones (P = .003). At T3, the vestibular face showed greater bleeding when compared to the proximal surfaces (p < .001), but no difference was found for the lingual surface and the other variables did not show differences. At this last evaluation point, the lower arch had 1.63 times greater gingival bleeding compared to the upper one. The lingual surface had greater bleeding when compared to the vestibular (P = .034) (available in Tables 6S–10S in the supplementary information). Evaluating each time for both visible plaque and gingival bleeding, there were no differences between groups at any time (Table 2). There was a statistical difference in the percentage of visible plaque between times T0 and T3, T0 and T4, and T1 and T3 (available in Table 11S in the supplementary information) and between time T3 and T4 for gingival bleeding (available in Table 12S in the supplementary information). The volunteers in the experimental group reported good acceptability of the app, and all volunteers reported that they would recommend it to other people (available in Table 13S in the supplementary information). When asked about the importance of OH, all totally agreed that OH is important and 75% agreed that the app encouraged them to take better care of their oral health. All volunteers agreed that they felt confident using the app and that they would use the app for additional 4 weeks after completing the study.

This study reported the results of a randomised clinical trial to assess the effectiveness of an app that was designed to improve OH in patients undergoing orthodontic treatment. There was a significant improvement (P < .05) in the percentage of visible plaque between times T0 and T3 (P = .001*), T0 and T4 (P = .001*), and T1 and T3 (P = .033*) for both groups, but there was no significant difference between the control group and the app group (P > .05). For the percentage of gingival bleeding, a statistical difference was observed between the T3 and T4 time points (P = .025*) for both groups without showing a statistical difference between the groups. Previous studies that used media-based and messaging apps to teach methods focused on oral health of adolescents, including video, selfies, text messaging, and face-to-face guidance, showed improvement in knowledge, attitudes, and oral health practices.20, 21, 22, 23, 24, 25, 26 It is also important to highlight that other digital platforms, such as YouTube and Instagram, play an important role in improving oral health amongst orthodontic patients, as they can easily find different OH techniques on these platforms., In the present study, a similar result regarding knowledge and attitudes could be observed at the end when all patients in the test group fully agreed that OH is important and, although there was no difference between the groups, there was a decrease in the VPI in the app group at all 4 initial moments of the study, indicating a change in the behaviour of these patients. Similarly, the control group had an improvement in the evaluated indexes. This improvement found in the control group can be explained by the Hawthorne effect, in which people participating in an experimental study change or improve their behaviour because they are participating in a study., The greater dental biofilm accumulation on the buccal surfaces can be explained by the presence of orthodontic appliances on these surfaces., The presence of a higher percentage of biofilm in the lower than in the upper arch is similar to that observed in a similar study in non-orthodontic patients. In general, studies on toothbrushing last between 2 and 30 weeks,33, 34, 35 whilst the present study lasted 16 weeks. A recent survey with an app for adolescents undergoing orthodontic treatment obtained favourable results in 12 weeks with a sample of 146 patients. Another factor related to toothbrushing is the frequency. Studies show that those who brush less frequently had a higher incidence of caries compared to those who brush more frequently. In this study, adolescents were instructed to determine 5 times daily to be reminded of OH. The effective mechanical removal of dental biofilm decreases the incidence of caries. Since most people are unable to achieve optimal biofilm control with just daily dental hygiene, it is recommended to perform OH more times a day. In addition, fluoride in toothpaste taken to the oral cavity several times a day has an important role in preventing caries. As this study was a pilot experiment with a small sample of individuals, it was possible to evaluate the great heterogeneity of the clinical parameters evaluated for each individual during the clinical trial. For example, the patient who claimed to be undisciplined had the second worst VPI. Observing the results of the indexes, there is a tendency to worsen in OH in the last period of the survey (T4) in the app group. Taking into account the age group studied, this reinforces the importance of further investigations regarding the model of the app created. This tool can be useful to change adolescents’ oral health behaviour and extend throughout life as long as it meets the needs of the population involved. A study with different motivational methods for OH in orthodontic patients demonstrated that all methods are equally effective when receiving OH boosts. The reminders used in medicine and dentistry show greater adherence and positive behaviour., In our study, the technique of teaching OH to the test group was the video presented at the beginning of the app. It is possible that only one video as an illustration of OH and the alarms as a reminder are insufficient for a significant improvement in the evaluated indexes. In addition, all patients in the app group received weekly contact via text message and were asked to send a photo of the calendar screens. Something similar happened in a study comparing 3 motivational techniques for OH in orthodontics, also with a drop in GBI compared to the initial and final time but without statistical difference between the groups tested. It is observed in the literature that the association of methods seems to be more effective in improving oral health, and no single instructional method serves all patients. We must take into account the desired group, learn more about its behavioural aspects, and try to group as many resources as possible. The small number of participants was a limitation of the study, as we depend on the individual characteristics of the participants, which was evident in this study. A larger number of patients should be evaluated, as well as factors such as tooth surface, arch, and region, which can influence outcomes and must be observed. Further studies are needed to demonstrate the feasibility of using a scientifically accredited mobile OH application for education, prevention, and monitoring of patients undergoing orthodontic treatment.

This study shows the potential utility of mobile app for improving the oral hygiene of adolescents. This study lays the groundwork for future studies that aim to identify the effectiveness of scientifically proven apps to motivate evidence-based oral hygiene routines.

None disclosed.