|Year : 2019 | Volume
| Issue : 5 | Page : 469-474
A 12-week, multicenter, normal-use evaluation of a manual toothbrush with angled bristle design
Ajay Madanlal Kakar1, Smruti Krishnan Nair2, Saurabh Saraf3
1 Department of Periodontology, Visiting Faculty, M.G.M. Dental College, Panvel, Maharashtra, India
2 Private Practitioner, Mumbai, Maharashtra, India
3 Regional Manager, Procter and Gamble, Professional Oral Care, London/Weybridge, UK
|Date of Submission||14-Aug-2018|
|Date of Acceptance||03-Oct-2018|
|Date of Web Publication||29-Aug-2019|
Dr. Ajay Madanlal Kakar
302-305, Shubham Atlanta, R. C. Marg, Chembur, Mumbai - 400 071, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Comparative clinical studies play a major role in evaluating the relative efficacy of commercially available manual toothbrushes to improve periodontal health. A manual toothbrush with angled, CrissCross® bristles has been shown to offer significant benefits relative to other toothbrushes. This study assessed whether the benefits could also be observed in real-world, normal use conditions in a large population. Materials and Methods: Generally, healthy adult participants were recruited from 24 dental institutions across India and given the manual toothbrush with angled bristles to use. Their periodontal health was assessed subjectively by dentists, using response categories, at the start of the study (baseline) and after 12 weeks of normal use. Participants themselves were also questioned. Data analyses were descriptive. Results: A total of 2157 participants took part in this multicenter study. At 12 weeks, oral hygiene status and gingival health were categorized as good to excellent in at least 85% of participants compared with 61%–62% at baseline, and no staining was found in 40% of participants compared with 30% at baseline. Oral health improvements were seen in 75% of participants. Most participants reported their brushing experience as giving good-to-excellent satisfaction (85%), improved brushing (82%), and a cleaner mouth (81%) and said they would recommend the brush (90%). Conclusions: In this uncontrolled real-world study, improvements were observed in oral health and hygiene following the use of the manual toothbrush with CrissCross bristles over 12 weeks. The results lend support to earlier findings of comparative clinical studies that demonstrated the beneficial effects of this toothbrush for periodontal health.
Keywords: Angled bristles, manual toothbrush, normal-use study
|How to cite this article:|
Kakar AM, Nair SK, Saraf S. A 12-week, multicenter, normal-use evaluation of a manual toothbrush with angled bristle design. J Indian Soc Periodontol 2019;23:469-74
|How to cite this URL:|
Kakar AM, Nair SK, Saraf S. A 12-week, multicenter, normal-use evaluation of a manual toothbrush with angled bristle design. J Indian Soc Periodontol [serial online] 2019 [cited 2019 Nov 22];23:469-74. Available from: http://www.jisponline.com/text.asp?2019/23/5/469/245329
| Introduction|| |
A healthy, disease-free periodontium need not be a distant dream, as it can easily be attained by stringently following optimum oral hygiene measures. Microbial plaque serves as a nidus that stimulates further periodontal disease progression, and most preventive and therapeutic measures are directed toward the elimination of this causative agent. The conventional toothbrush remains the instrument most commonly used to remove dental plaque. If tooth brushing is performed using a properly designed brush with an effective technique and for a sufficient duration of time, plaque control can be achieved on a permanent basis.
In 1999, an innovative toothbrush design with angled, CrissCross ® bristles [Oral-B Cross-Action, Procter and Gamble, Cincinnati, OH USA] was introduced. The research and development behind this brush reflected the manufacturer's commitment to optimizing toothbrush design for effective plaque removal. In contrast to traditional vertical bristles, the CrossAction toothbrush was developed with a unique angled arrangement of bristles along the horizontal axis of the brush [Figure 1]. This arrangement improved the potential for plaque removal on approximal surfaces and along the gumline by enhancing penetration of bristles into interproximal spaces. When the CrossAction toothbrush was compared with over 80 leading manual toothbrushes in laboratory comparisons, it demonstrated greater interproximal penetration and cleaning effectiveness. The clinical advantages of the CrossAction brush versus other designs have been shown in many single-use and long-term clinical comparisons with various commercially available toothbrush models.
Whereas comparative clinical studies are essential for establishing the safety and efficacy of new products, other types of investigations can be of value. In the present study, we evaluated the CrossAction toothbrush in long-term, real-world normal use, rather than in an experimental context with questionnaires in which responses were categorized. It was conducted to assess the subjective, qualitative responses made by dentists who examined participants along with responses from participants. The study was a multicenter project with a large number of participants from dental institutions across India to examine whether real-world data complemented results obtained from comparative, controlled, and experimental studies.
| Materials and Methods|| |
A central office was set up in Chembur, Mumbai, for coordinating the study with a central team comprised the authors. The central office planned to recruit at least 20 dental institutions distributed in four zones of India: North, South, West, and Central. A preliminary meeting was held in Chennai in September 2015 where heads of 36 dental institutions were invited. The entire project was explained at the meeting, and 24 institutions were signed up for the study. Each study institution appointed a study supervisor who then appointed two postgraduate dentists as the “dentists” in charge of recruiting participants and conducting study evaluations. Each dentist was asked to recruit 50 participants based on study inclusion criteria. In total, the study aimed to recruit 2400 participants.
Participants were recruited from each university dental clinic. Participants were required to be adults (18–60 years), in good general health, having at least 20 natural teeth, and a maximum of five implants. Participants were excluded if they were not using any form of oral hygiene, or if they had a negligible number of teeth, a severe infection, or any potential problems that could interfere with study participation. Throughout the course of the study, participants were not allowed to receive elective dentistry (including prophylaxis), use oral hygiene products other than the assigned toothbrush and their usual toothpaste or participate in any other oral/dental studies. Participants violating any of these criteria were removed from study participation or excluded from the data analyses.
Each institution was sent study booklets for recording all study data and manual toothbrushes for the 100 participants they were asked to recruit. Before the start of the study, each participant was asked to respond to a baseline questionnaire that consisted of six questions: toothbrush brand currently used; gender; smoking habits; betel leaf (paan/gutka) or tobacco chewing habits; left or right handed; and use of medication. The dentist then carried out a baseline assessment of participants for oral hygiene status, gingival health, and tooth stain. All responses were subjective, qualitative assessments not based on any formal index. For oral hygiene status and gingival health assessments, responses were made according to one of five categories: “excellent,” “very good,” “good,” “fair” or “poor.” For the stain assessment, responses were made to one of the four categories: “none,” “light,” “medium” or “heavy.”
Participants were then given a new CrossAction toothbrush and asked to use it in place of their current toothbrush for 12 weeks. No specific brushing or oral hygiene instructions were given to participants who were requested simply to use the new brush in their customary manner and observe any effects it had on their oral health. Participants were then recalled to the study institution after 12 weeks and asked to respond to the following multiple-choice questions:
- What was your satisfaction level with the Oral-B CrossAction toothbrush?
- Does the Oral-B CrossAction toothbrush help improve brushing?
- How much has the Oral-B toothbrush affected your oral health?
- Does the Oral-B CrossAction toothbrush provide the feeling of a better whole mouth clean compared to your previous manual toothbrush?
- Would you recommend the Oral-B toothbrush to your friends?
Response categories for question (a) were “excellent,” “very good,” “good,” “fair,” or “poor;” for questions (b) and (d) were “strongly agree,” “agree,” “neither agree or disagree,” “disagree” or “strongly disagree;” for (c) were “major improvement,” “improvement,” “unchanged,” “slight deterioration” or “major deterioration;” and for (e) were “yes” or “no.”
Follow-up examinations after 12 weeks were conducted by the same dentist who conducted the baseline examinations, and hygiene status, gingival health, and staining were reassessed. In addition, the dentists recorded the change in oral health of the participant (recorded as “major improvement,” “small improvement,” “unchanged,” “small deterioration,” or “deterioration”) and the physical state of the toothbrush (recorded as “excellent,” “slightly flared,” “worn,” “completely worn,” or “poor”).
Responses by participants and dentists were recorded by the dentist in the study booklet and returned to the central office. Given the design of this study and the absence of control data, all data analyses were descriptive and graphical presentations were used to show percentages of participants within each response category.
| Results|| |
Twenty-four dental teaching institutions participated in the study. The distribution of participating institutions in the four Indian zones reflected the greater number of institutions found in the southern states: South nine, West six, North five, and Central four. Across all institutions, 2304 participants were enrolled, and 2157 completed the study.
Sixty-four percent of the total sample size was female, and the majority of participants (94%) were right handed. Only 5% of participants were smokers, only 4% had betel leaf/tobacco chewing habits, and only 1% used medication. With these small sample sizes, no analyses were carried out for these attributes.
[Figure 2] shows the distribution of the toothbrush brand used by participants before the study. Colgate was the most commonly used brush (57%) followed by Oral-B (22%).
|Figure 2: Percentage of participants using each brush type before the start of the study|
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Baseline oral hygiene status as assessed by the dentists is summarized in [Figure 3]a, which shows that the majority of participants (61%) had good-to-excellent oral hygiene. The oral hygiene status after 12 weeks, also shown in [Figure 3]a, revealed a shift toward a better status, with an enhanced percentage of participants (85%) having good-to-excellent oral hygiene. Gingival health status at baseline and after 12 weeks as assessed by the dentists is summarized in [Figure 3]b. Results showed a pattern similar to changes in oral hygiene. The percentage of participants with good-to-excellent gingival health (86%) after 12 weeks was numerically higher than the percentage of participants (62%) in the same categories at baseline. Together the results indicate that by the end of the study participants experienced an improvement in their oral hygiene and gingival health.
|Figure 3: Percentage of participants in each status category at baseline and at 12 weeks: (a) oral hygiene; (b) gingival health|
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Tooth staining, as assessed by dentists, at baseline and after 12 weeks is illustrated in [Figure 4]a and [Figure 4]b, respectively. Almost one-third of the participants (30%) showed no staining at baseline; this rose to 40% at 12 weeks. Participants with light staining remained the same (~43%) at both baseline and after 12 weeks whereas there were fewer participants with medium to heavy staining after 12 weeks (16%) versus baseline (25%).
|Figure 4: Percentage of participants in each staining category: (a) at baseline; (b) at 12 weeks|
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At the 12-week examination, the change in oral health status was assessed by the dentists and was also self-assessed by the participants. The results obtained from the dentists' evaluation and from the participants' self-assessment are shown in [Figure 5]a and [Figure 5]b, respectively. Results were similar for both types of assessment: improvements (small to major) were seen in 75% of participants when assessed by the dentists and in 81% of participants when self-assessed.
|Figure 5: Percentage of participants in each oral health category: (a) by dentist evaluation, (b) by participant evaluation|
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Participants' satisfaction with the brush after 12 weeks of use is illustrated in [Figure 6]a. Satisfaction was expressed as good to excellent in 85% of participants. When asked after 12 weeks whether the CrossAction brush improved the brushing of their teeth, the majority of participants (82%) agreed or strongly agreed that their brushing was improved [Figure 6]b. When asked whether they felt they had a cleaner mouth a similar pattern emerged, with the majority of participants (81%) expressing that they agreed or strongly agreed [Figure 6]c.
|Figure 6: Percentage of participants in each category: (a) satisfaction levels with the brush; (b) improvement in brushing; (c) feeling of a cleaner mouth|
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The dentists assessed brush status after 12 weeks and results are shown in [Figure 7]. More than half of the brushes (57%) demonstrated a slight flaring of the bristles; 19% of the brushes were in excellent condition.
|Figure 7: Percentage of participants in each brush status category after 12 weeks of use|
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When asked about their willingness to recommend the brush to a friend, the majority of participants (90%) gave a positive response.
The 12-week data for change in oral health status as assessed by dentists and the willingness of participants to recommend the CrossAction brush to a friend were evaluated across institutions to examine the consistency of the findings. Results for the percentage of participants showing major and small improvements in their oral health are displayed in [Figure 8]a and the results for the percentage of participants willing to recommend the brush are shown in [Figure 8]b. For both assessments, the pattern that emerged was consistently favorable across institutions, with only a small number of centers showing less favorable results.
|Figure 8: Percentage of participants at 12 weeks showing (a) major and smaller improvements in oral health according to dentist evaluation; (b) willingness to recommend Oral-B CrossAction to a friend|
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| Discussion|| |
Well-designed, randomized, blinded, and comparative clinical studies are important for evaluating the effectiveness of novel dental hygiene devices and innovations to brush head design. Results of such studies guide product development and help consumers make informed choices when deciding between marketed models. Since its introduction in 1999, the efficacy of the CrossAction manual toothbrush has been examined in many comparative clinical trials, and the results have consistently proven its advantages for effective plaque removal and improved gingival health.,, In addition, a systematic review by Slot et al. showed the angled bristle manual toothbrush design had the highest numerical mean plaque reduction compared with multilevel and bi-level configurations. The unique CrissCross bristle arrangement appears to be a major factor accounting for the superiority of the CrossAction brush, but other features of the brush may contribute. For example, the handle has been designed to achieve maximum ergonomic benefit and could be expected to give a positive brushing experience, which is important for promoting compliance.
Assessing the safety of innovative product designs is another important function of clinical trials including soft and hard oral tissue assessments. No safety concerns have been identified in clinical studies of the Oral-B CrossAction toothbrush. An example of a feature that contributes to the safe and positive experience of using the CrossAction brush is bristle end rounding. In a study of manual toothbrushes with different bristle stiffness, Zimmer et al. reported that even though a stiffer straight cut bristle might be more effective in plaque removal, it could cause soft-tissue laceration and damage. End-rounded bristles continue to be incorporated into the CrossAction design to ensure its safety.
While there has been a plethora of clinical research on the brush, less is known about everyday experience with CrossAction from dental professionals or users. Real-world, practice-based investigations can be of value when results are considered alongside findings from experimental studies. Warren et al. assessed the effectiveness and acceptability of an Oral-B power toothbrush in a general practice study in the United States with over 16,000 patients over 8 months. Subjective evaluations of dental professionals were categorized to assess changes in oral health status and a survey was used to assess the attitude of professionals and patients toward the brush. That practice-based study confirmed the oral health benefits of the power toothbrush demonstrated in controlled clinical studies. A similar, practice-based, approach was used in a study in Mexico with 200 adult participants to evaluate the efficacy of an oral hygiene regimen, consisting of an advanced Oral-B CrossAction manual toothbrush with a CrissCross bristle pattern and a stabilized stannous fluoride dentifrice. Categorical scales were used by dental professionals to evaluate plaque coverage and gingivitis after 4 weeks of treatment and supporting well-established clinical trial data, improvements were observed in reducing overnight plaque coverage and gingival inflammation.
Categorical scales were also used in the present real-world, multicenter, long-term study. Dentists assessed participants for their oral hygiene, gingival health, and staining, and based on their subjective evaluations, results were grouped into categories. Dentists reported that both oral hygiene and gingival health were categorized as good to excellent in more participants (85%) after 12 weeks of using the CrossAction toothbrush than at the start of the study (61%–62%), and more participants showed no staining at 12 weeks (40%) than at the start of the study (30%). At 12 weeks, improved oral health was seen in 75% of participants when assessed by dentists, and this result corroborated the finding that, when self-assessed, 81% of participants reported improved oral health. Regarding their brushing experience, the majority of participants responded positively, reporting that the brush gave them good to excellent satisfaction (85%), improved brushing (82%), and a cleaner mouth (81%). Nearly 90% of participants replied that they would recommend the brush to a friend.
Also observed was the consistency between participating institutions across India in their reporting of improved oral health and participant willingness to recommend the brush, with only a small number of centers showing more modest responses compared to the rest.
| Conclusions|| |
Brushing with the Oral-B CrossAction toothbrush, with its innovative brush head design for effective cleaning of hard-to-access areas, was observed to improve oral health and gingival health, reduce staining, and give a positive brushing experience in a large number of participants. These results cannot independently be interpreted to demonstrate the clinical effectiveness of this toothbrush, as the study was not a randomized, blinded, and controlled clinical trial. Mainly, the data were subjective, and with no control sample, there were no statistical comparisons of efficacy. However, the effectiveness of the brush has been proven previously in numerous well-designed clinical trials, and this study was not intended to serve that purpose. Instead, results should be seen as providing real-life, normal use observations of the oral health benefits of CrossAction in a large population to complement clinical data.
The authors wish to thank all the 24 Dental Colleges, Deans, and postgraduate dentists who took part in the program, the staff of Procter and Gamble India who provided all the materials and funded the program, and Dr. Jane Mitchell and Ms. Lisa Sagel for their help in the production of this paper.
Financial support and sponsorship
This study was funded by Procter and Gamble.
Conflicts of interest
Dr. Saurabh Saraf is an empolyee of Procter & Gambel UK. Dr. Ajay Kakar and Dr. Smruti Nair were commissioned by Procter & Gamble to advise, plan and oversee the program.
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