|Year : 2012 | Volume
| Issue : 3 | Page : 375-380
Efficacy of a new interdental cleaning aid
Fouzia Tarannum1, Mohamed Faizuddin1, Shanmukha Swamy2, M Hemalata1
1 Department of Periodontics, M. R. Ambedkar Dental College and Hospital, Bangalore, Karnataka, India
2 Department of Periodontics, K.L.E Institute of Dental Sciences, Bangalore, Karnataka, India
|Date of Submission||26-Mar-2011|
|Date of Acceptance||11-Apr-2012|
|Date of Web Publication||12-Sep-2012|
79/13, 5th cross, Pillanna Garden, 1st stage, Bangalore 560 084, Karnataka, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: It is now well established that removal of bacterial plaque can reduce the severity of chronic inflammatory periodontal disease. Periodontal disease is seen to progress faster interdentally and plaque control in these areas is of great importance. Various types of interdental cleaning aids have been developed in recent years. This study was aimed at evaluating the efficacy of a newly developed interdental cleaning aid, BrushPick, in a split mouth randomized clinical trial. Materials and Methods: This was a split mouth design study where the quadrant on one side of the oral cavity served as the control while another quadrant on the opposite side served as the test sample. Fifty-seven patients with mild-to-moderate periodontitis, presenting with open interdental embrasures, were selected for the study. After non-surgical periodontal therapy, they were asked to use the BrushPick in the embrasures on one side of the arch in a spilt mouth design study and the embrasures on the other side acted as controls. The Rustogi et al. modified Navy plaque index (RMNPI) and interdental bleeding index (IBI) were recorded at baseline, seven days, 14 days, and 28 days. Statistical analysis: The mean differences between test and control sites were compared using the student " t" test. The mean difference was compared between different durations using analysis of variance (ANOVA). Results: The mean RMNPI was significantly different between the test and control sites at P<0.001 on both days 14 and 28. At 28 days the mean IBI was 0.08 (SD=0.02) for the experimental sites and 0.28 (SD=0.11) for the control sites. The difference was statistically significant at P<0.001. ANOVA showed that the mean RMNPI scores and mean IBI scores showed a statistically significant difference when compared at different durations at the test sites (P<0.0001). But, at the control sites there was no significant change. Conclusion: This study suggested that BrushPick reduces plaque and gingival bleeding in open interdental embrasures. Further large sampled clinical trials and comparative studies using gold standard interdental cleaning aids are required to establish the efficacy of this device.
Keywords: BrushPick, efficacy, interdental bleeding index, interdental embrasures, modified navy plaque index, periodontal disease
|How to cite this article:|
Tarannum F, Faizuddin M, Swamy S, Hemalata M. Efficacy of a new interdental cleaning aid. J Indian Soc Periodontol 2012;16:375-80
| Introduction|| |
The bacterial plaque that forms on all hard and soft oral tissues is considered to be the principal etiological agent in periodontal diseases. The accumulation of plaque facilitated by poor oral health maintenance predisposes to gingivitis, leading to the onset of periodontal inflammation. The role of bacterial plaque as an etiological factor in the development of chronic inflammatory periodontal disease is well-documented. ,,, Mechanical plaque control is the most widely accepted preventive measure for periodontal disease. It is now well-established that removal of bacterial plaque, both mechanically and/or chemically can reduce the severity of chronic inflammatory periodontal disease. There is substantial evidence to suggest that improvement in oral hygiene will lead to reduction in the prevalence and severity of gingival inflammation. , It has also been convincingly demonstrated that periodontal disease is most frequent and severe in the interproximal areas. In addition periodontal disease is recognized to progress faster interdentally.  Subsequently, achieving adequate plaque control in these areas is of great importance.
Various types of toothbrushes have been designed to achieve maximum plaque removal.  Although the toothbrush is successful in removing plaque at the buccal, lingual, and occlusal surfaces, it cannot completely remove plaque from the interproximal surfaces. Thus, maintaining oral hygiene at the interproximal areas call for special devices.  Different types of interdental cleaning aids that have been developed for this purpose include dental floss, toothpicks, and interdental brushes. , This wide range of commercially available interdental cleaning aids make various claims for their beneficial effects in terms of reduction in plaque scores and gingival inflammation. In recent years, the market is flooded with an array of oral hygiene devices each one claiming superiority over the other. One such newly introduced product is the BrushPick (Dental Concepts, Paramus NJ, USA). This polythene plastic product has two cleaning ends: One has a scored triangular-shaped tip and the other end has a flexible stem with three rows of lateral bristles in one plane. It is shown in [Figure 1]. These new interdental cleaners on one end resemble the interdental brushes, but do not have metal or fiber bristles, instead they have small elastomeric fingers protruding perpendicularly from a plastic core. The other end is designed like a tooth pick which is circular in cross section.
The purpose of this study was to evaluate the role of the BrushPick (test product) in reducing plaque accumulation and gingival inflammation at the open interdental embrasures in a split mouth randomized clinical trial.
| Materials and Methods|| |
Subjects aged between 32 and 55 years, were enrolled for the study. A total of 154 subjects were screened, among whom 47 did not meet the study inclusion criteria and 50 refused to participate, with only 57 meeting all the study criteria to be enrolled.
Each subject was to have a minimum of 18 scorable teeth (excluding third molars, teeth with orthodontic appliances, bridges, crowns or implants). To be included in the study, the subjects were required to have at least five interproximal open embrasures (complete loss of interdental papilla) with the adjacent teeth being the natural dentition. The subjects were required to have at least two embrasures on one side of the oral cavity and the remaining on the other. The interdental embrasures presenting with marginal gingival recession were excluded from the study.
In addition, the subjects were to be current manual toothbrush users. Reasons The reasons for exclusion were; presence of aggressive periodontitis, presence of severe periodontitis, that is, clinical attachment loss of ≥ 5 mm,  any physical limitations that might compromise the normal tooth brushing technique, evidence of neglected oral hygiene or major hard or soft tissue lesions or trauma, gross caries or the other hard tissue pathology, heavy calculus, orthodontics, prosthodontics, and oral piercings, a medical condition with a requirement of prophylactic antibiotic coverage before dental treatment, use of antibiotic therapy or anti-inflammatory medications in the previous 28 days, use of anticoagulants, steroid therapy, and smoking status. Diabetes, rheumatic fever, hepatic or renal disease and other transmissible diseases, were each also a basis for exclusion.
After selection, the patients were informed about the purpose and duration of the study. Upon their decision to participate all the subjects gave a written informed consent, and the protocol was approved by the Institutional Review Board.
This was a split mouth design study, conducted using the body part randomization method. 'Body-part randomization' is a randomized controlled clinical trial method in which different parts of a person are randomized to be treated differently. The quadrant on one side of the oral cavity served as the control, while the quadrant on the opposite side served as the test. The quadrants were allotted to test or control using simple random sampling, employing the toss of a coin.
At the baseline visit, oral examinations were performed, which included plaque level and interdental bleeding index at the designated sites. The same were repeated at one (7 days), two (14 days), and four (28 days) weeks. The indices were recorded by two examiners, each examiner recording one of the two indices and the examiners were blinded about the test and the control sites. The third examiner conducted the randomization procedure.
Plaque was recorded in the interproximal areas of the teeth using the Rustogi et al. modification of the modified navy plaque index (RMNPI).  Gingival bleeding in the interdental embrasure was recorded using the interdental bleeding index. 
All the subjects were given a thorough periodontal therapy for four weeks (wash period), prior to the start of the trial. The subjects had to refrain from any elective, non-emergency dental care including prophylaxis, during the study. The subjects were given a prophylaxis to remove all supragingival calculus and plaque; periodontal therapy included oral hygiene instructions (brushing the teeth with a toothbrush twice daily using the modified Bass technique) and scaling and root planning performed under local anesthesia. Full-mouth scaling and root planning were performed by the periodontist over one or two appointments, with a one-week interval between each appointment. During the wash-out period only maintenance therapy was performed. Maintenance therapy included oral prophylaxis and reinforcement of oral hygiene instructions. If there was a difference in the baseline level of plaque or gingivitis, the subjects should had to be stratified based on the baseline values, hence, oral prophylaxis was done before recording the baseline values, to get a uniform plaque index of 0.
Patients were instructed to use the test product for embrasures on one side (test side) and the quadrant on the opposite side served as the control side. The test product was used twice daily along with the conventional brushing technique from day 0 (baseline). The patients were instructed to gently slide the pick end into the interdental embrasure and move back and forth and up and down within the embrasure, to remove gross food debris and massage the gums. The brush end had to be inserted and moved similarly over the interdental area to remove the plaque.
The product use by the subjects was supervised by the authors at the baseline visit, to ensure that the product was used correctly. The subject was informed of the designated interdental sites to be treated with the assigned product once daily. The subjects returned at one, two, and four weeks for a dental history update, recording of the parameters and compliance review, and additional product as needed. Between the baseline and 28 days examination, each subject was instructed to clean his/her teeth daily, using a standard brushing technique and dentifrice. The test product was to be used alongside, as instructed. As an aid to establish compliance, the patients were instructed to return the test product at the end of the study.
Sample size determination and power analysis
The sample size was estimated to be 86 inter-dental spaces in each group to detect a difference of 25% plaque reduction between the test and control site, with anticipated effect size of 0.8, desired statistical power of 80%, and an a level of 0.05.
According to the guidelines for conducting plaque and gingivitis clinical trials, where possible, the same examiner had to examine the same patients throughout the study and the examiners had to be self-calibrated to reduce intra-examiner error.  Hence, five subjects not involved in the study and presenting with open interdental embrasures were used to calibrate the examiners. The examiners recorded RMNPI and IBI for these subjects on two occasions, 24 hours apart. Kappa coefficient for intra-examiner agreement was 0.743 for RMNPI and 0.701 for IBI.
The preferred statistical analysis when two treatments are being compared is a comparison of mean scores by the independent sample t-test. An analysis of covariance, using the baseline scores as the covariate, must be done whenever the comparison between more than two values is required.
The means were calculated for the plaque and gingival index scores at 0, 7, 14, and 28 days, both for the test sites and control sites. The mean values of the individual sites were pooled for the test sites and for the control sites, because pooling of individual patient data would end up with only a few observations and we would end up with fewer data, and hence, less statistical power. Second, not all patients here had the same number of interdental embrasures and individual patient mean comparisons would bias the results.
Mean differences between test and control sites were compared using student " t" test. The mean difference was compared between different durations using ANOVA (analysis of variance). The results were considered statistically significant at P<0.05.
| Results|| |
[Figure 2] shows a consort flow chart depicting the selection of the study population and allocation of sites. Not all sites in the subjects' mouths were considered suitable for the study, as the interproximal areas needed to be accessible to the interdental aid being tested. As would be expected, sufficiently accessible sites were more frequently found toward the back of the mouth.
A total of 258 interproximal embrasures were selected for the study among the 57 patients, among which 122 were randomly allotted for the control sites and the remaining 136 for the experimental sites. Eight patients (five males and three females) were lost to follow up of whom five patients discontinued the initial periodontal therapy and three patients did not comply with the oral hygiene instructions given. Hence, only 49 patients (29 males and 20 females) and 189 embrasures were available for statistical analysis, among whom 98 were experimental sites and 91 were control sites. The statistical analysis conducted was per-protocol analysis, as the data from patients lost to follow up was not utilized. [Table 1] shows the demographic factors and the number of sites among the different genders as recorded at the baseline. Mean age of the study population was 42.35 years (SD=12.4)
[Table 2] shows the means of the plaque index (RMNPI) at the test and control sites. The mean RMNPI index at baseline was 0 for both the test and the control sites. At days 7, 14, and 28, the mean PI was higher for the control sites compared to the test site. On day seven, the mean RMNPI was 0.19 (SD=0.04) at the test sites and 0.43 (SD=0.15) at the control sites, and the difference was statistically significant at P=0.003. Similarly, the mean RMNPI was significantly different between the test and control sites at P<0.001, on both days 14 and 28.
[Table 3] shows the means of the interdental bleeding index (IBI) at the test and control sites. The mean IBI was higher for the control sites than for the test sites at all times of examination, starting from the baseline. However, the difference was not statistically significant on days 0 and 14. At 28 days the mean IBI was 0.08 (SD=0.02) for the test sites and 0.28 (SD=0.11) for the control sites. The difference was statistically significant at P<0.001.
|Table 3: Means of interdental bleeding index at the test and control sites|
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[Table 4] shows the ANOVA and p-value for the statistical significance, for the difference between the mean values at different durations among the test and control sites. ANOVA showed that the mean RMNPI scores showed a statistically significant difference when compared at different durations, at the test sites (P<0.0001). However, at the control sites there was no significant change. Similarly, the mean IBI scores also showed a significant difference at the test sites (P<0.0001), but at the control sites there was no significant difference.
|Table 4: Statistical significance using ANOVA for difference between mean values at different durations among the test and control sites|
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[Table 5] shows the Pearson's r values for the correlation between the plaque index and interdental bleeding index. There was a positive correlation between the plaque index and the interdental bleeding index. This suggested that there was an increase in values of the plaque index, with increase in the values of the bleeding index.
|Table 5: Correlation between plaque index and interdental bleeding index|
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Post hoc power analysis
There was an average 50% reduction in the plaque and gingival inflammation at sites where the test device was used as compared to a 10% reduction at the control sites. Post hoc power analysis was conducted considering the final sample size of 98 for the test group and 91 for the control group. Cohen's d for the effect size of the study was 2.52, with a power of 100% at a a significance of 0.001.
| Discussion|| |
Destructive periodontitis leads to denudation of the root surfaces and wide open inter-proximal spaces. The cementoenamel junction and root concavities are thought to be important anatomical factors favoring plaque retention interdentally. A primary means of personal oral hygiene is the removal, or at least the disturbance of dental plaque, as a result of which there is reduction in the gingival inflammation. This study has sought to assess the effect of a new interdental cleaning aid in the prevention of inter-proximal plaque accumulation and gingival inflammation.
Earlier studies have evaluated the plaque removal effect of various interdental cleaning devices as measured by plaque indices. However, literature in the recent years has suggested that reduction in gingival inflammation and bleeding is more acceptable than plaque reduction alone in testing the efficacy of oral hygiene aids. An increase in efficiency of the patients in removing plaque is reflected by the improvement in gingival inflammation and bleeding. Our results have suggested that there is a positive correlation between the plaque index and bleeding index.
It has been well-documented that a combination of flossing and brushing is more effective than brushing alone, particularly in the gingival responses and bleeding at the inter-proximal sites. Studies by Gjermo and Flotra,  Wolffe  and Maureillo et al.  have attempted to compare the effect of floss and interdental brushes in the removal of proximal plaque. Wolffe attempted to compare the proximal plaque removal of these devices in a clinical trial lasting one week, which would allow only minimal orientation of the aid being used. Interdental brushes have been proposed as superior devices for cleaning larger inter-proximal spaces, as the brush can conform to the space.
A study that compared the interdental plaque removal capacity of dental floss, cylindrical, and conical interdental brushes, for individuals in periodontal maintenance care, suggested that interdental toothbrushes, regardless of their shape, were more efficacious in interdental supragingival plaque removal than dental floss. This study recorded the Loe and Silness plaque index in the interdental embrasures. 
Currently, the most accepted evidence-based scientific reports are the systematic reviews of randomized controlled clinical trials. The efficacy of dental floss, in addition to a toothbrush, on plaque and parameters of gingival inflammation was evaluated in a systematic review.  A meta-analysis was performed for the plaque index and gingival index. A greater part of the studies did not show a benefit for floss on plaque or the clinical parameters of gingivitis. In the light of the results of this comprehensive literature search and critical analysis, it is concluded that a routine instruction to use floss is not supported by scientific evidence.
A systematic review  was conducted to assess the effect of the use of interdental brushes in patients, as an adjunct to tooth brushing, compared to tooth brushing alone, or the other interdental oral hygiene devices on plaque and the clinical parameters of periodontal inflammation. It was a systematic review of nine randomized controlled trials with a meta-analysis of some included studies. The clinical parameters of periodontal inflammation, such as, plaque, gingivitis, and bleeding were selected as the outcome variables. The results concluded that as an adjunct to brushing, the interdental brush removes more dental plaque than brushing alone. A significant improvement in plaque scores was observed for the groups using interdental brushes in all but one study. In those studies that assessed bleeding scores a significant improvement was also observed. Among the studies that assessed gingival health according to the Loe and Silness Gingival Index, two of the three showed a significant reduction, while one study showed no change. The studies showed a positive significant difference using an interdental brush with respect to the plaque scores and bleeding scores. The majority of the studies presented a positive significant difference in the plaque index, when using the interdental brush compared with floss.
Recently introduced into the market, BrushPicks are double-ended, interdental cleaners with similarities to the interdental brush and toothpick. Samuel et al.  compared the BrushPicks and glide floss, in improving plaque, gingivitis, and bleeding on probing, over a period of four weeks. At the end of four weeks, the use of the BrushPick significantly improved both gingivitis and bleeding on probing compared to glide floss.
Whenever a new device is designed for a therapeutic purpose it has to undergo an efficacy trial before being launched into the market for patient use. To date, there are no published reports that deal with the efficacy of this newly designed interdental cleaning aid. Hence, this efficacy trial was conducted.
Our study was a case control study, with a split mouth design, where one-half of the oral cavity served as the test side and the other as the control side. Fifty-seven (34 males and 23 females) subjects, aged between 32 and 55 years, were recruited in this study. This age range was selected because signs of chronic periodontitis were more prevalent in subjects of age above 30 years, however, above 55 years there was increased prevalence of missing teeth. Patients had to have moderate periodontitis, because patients presenting with severe periodontitis would have deep periodontal pockets and severe recession, which would demand the use of advanced interdental cleaning methods like interdental miniature bottle brushes or unitufted brushes.
All the patients received non-surgical periodontal therapy and the test product was used after the clinical signs showed periodontal health. This helped in better evaluation of the effectiveness of the device. In our study only open inter-proximal areas large enough to receive the test product were included. It was suggested that where the inter-proximal tissues were intact damage could result from the use of such devices.  Furthermore, it was also necessary to allow sufficient space to be present between the teeth, in order to facilitate the visualization and scoring of proximal surface plaque. However, interdental embrasures with gingival recession were excluded, because, as a consequence of gingival recession there was exposure of the root surfaces and the root concavities. Root concavities and root grooves would not be sufficiently cleaned with such a simple device; they needed a more sophisticated inter-dental aid.
The indices recorded in our study were the inter-proximal scores of RMNPI  and the interdental bleeding index. The clinical measurement of dental plaque was a fundamental necessity in clinical trials of plaque removal interventions. The plaque indices remained the principle assessment of the clinical outcome in such clinical trials. Weight was recently assessed as an objective measure of plaque formation. Although it was suggested that there appeared to be no significant advantage in using plaque weight in the periodontal clinical trials. 
The new plaque index  used in our study assesses the amount of plaque in the tooth area bounded by the tooth contact, the free gingival margin, and mesial or distal line angles. The use of this new index enables the examiner to evaluate and record both the gumline (marginal) and inter-proximal areas of the tooth, thus giving these anatomical areas increased importance. Gingival bleeding after a defined method of inter-proximal stimulation is a valid indicator for the presence of inflammation in the mid inter-proximal gingival tissues. The inter dental bleeding index  is a simple procedure for monitoring the gingival health of a patient.
The results of our study showed that there was reduction in the plaque and gingivitis score in the areas where the test product was used. The reasons for the significant differences in oral health for the group using the test product were attributed to the flexibility and the unique design of the device and the ease of use. Lower plaque scores and bleeding scores might have occurred had the subjects used the device for more than four weeks. In fact, few patients mentioned that four weeks was insufficient time to become accustomed to using the device. The effects of a single session of oral hygiene education were discussed in an article by Elliot et al.  They showed, as part of their study, that instruction and motivation of subjects produced a significant lowering of plaque scores after a two-week period. When changes in the mean plaque score and bleeding score were assessed, both sites exhibited decreasing mean scores over time. The decrease was statistically significant in the test site. There was a dramatic decrease in the scores at two weeks. The reasons for the significant difference in oral health were attributed to the flexibility and the unique design of the device, and the ease of use. The results of our study further established the necessity for use of interdental cleaning aids in open embrasures.
A previous study  that compared the use of a tooth pick (wooden interdental stimulator), single tufted brush, and waxed dental floss, in proximal surface cleaning, suggested that a majority of the patients preferred the tooth pick in place of the floss or the single tufted brush. The reason given was that they were convenient to carry and quick and simple to use. Several patients mentioned that the bristles of the tufted brush readily sprayed and the problem with dental floss was manual dexterity.
The BrushPick appears to be a modification of the most commonly used and preferred interdental aid, the hand-held wooden toothpick. Recently, a systematic review was conducted to review the literature on whether a hand-held triangular wood-stick, as compared to no adjunct or other interdental cleaning device in addition to daily tooth brushing, could improve the clinical parameters of gingival inflammation. Evidence from the controlled trials, most of which were also randomized, showed that wood-sticks did not have an additional effect on visible interdental plaque or the gingival index, but did however, provide an improvement in interdental gingival inflammation by reducing the bleeding tendency. 
Nevertheless, it appears that in our study, the patients removed plaque consistently when using the BrushPick. It could be suggested that patients found the use of the BrushPick easier to carry and simple to use. The BrushPick showed better results in controlling plaque and gingival inflammation compared to the control sites, suggesting that it played a role in the maintenance of oral hygiene. As only open embrasures without gingival recession were included in the study, the results of this study could be cautiously applied only to specific type of embrasures. However, with only a couple of studies published, the role of the BrushPick in interdental hygiene did not provide any evidence-based conclusions.
The results of the present split mouth, randomized, controlled clinical trial suggest that in open interdental embrasures, the BrushPick significantly reduces plaque accumulation and gingival inflammation, as measured by RMNPI and IBI, respectively. The results must be cautiously interpreted and applied with consideration given to the limitations of the study.
There is a great need to conduct proper large-scale studies on the usefulness of this simple interdental cleaning aid, to maintain or improve oral health. However, trials to evaluate its efficacy in comparing with time-tested interdental aids is also necessary. It is yet to be hoped that improved toothpastes or other inexpensive approaches may eventually control gingivitis, without the need for interdental cleaning.
| Acknowledgments|| |
The authors thank Dr. Jayanthi D, Professor, Department of Periodontics, M. R. Ambedkar Dental College and Hospital, for her cooperation in conducting the study. Statistical assistance was provided by Mr. K.P. Suresh, statistician, National Institute of Animal Nutrition and Physiology, Bangalore, Karnataka, India.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]