Randomized clinical controlled trial on the effectiveness of conventional and orthodontic manual toothbrushes

Orthodontics Orthodontics Randomized clinical controlled trial on the effectiveness of conventional and orthodontic manual toothbrushes Lisiane Krieger Gomes(a) Carlos Frederico Sarmento(b) Flávio Roberto Guerra Seabra(b) Patrícia Bittencourt Dutra dos Santos(c) Fábio Henrique de Sa Leitão Pinheiro(d) (a) Master’s degree program in Dentistry, Potiguar University (Laureate International Universities), Natal, RN, Brazil. (b) Department of Periodontics, Potiguar University (Laureate International Universities), Natal, RN, Brazil. (c) Department of Orthodontics, State University of Rio Grande do Norte, Caicó, RN, Brazil. (d) Department of Orthodontics, Potiguar University (Laureate International Universities), Natal, RN, Brazil. Abstract: The objective of this study was to compare the effectiveness of two manual toothbrushes (conventional and orthodontic). The following clinical parameters were used: VPI (visible plaque index) and GBI (gingival bleeding index). Patients, 64 total (30 males and 34 females), in the permanent dentition, with a mean age of 17.8 years, were randomly selected from a practice specializing in orthodontics. Each participant received audio-visual instructions on oral hygiene as well as a kit of materials containing two manual toothbrushes (orthodontic and conventional). Each toothbrush was randomly allocated to one side of the mouth (splitmouth design) and used for a period of approximately 4 weeks. The VPI and GBI were measured by a single calibrated examiner before (T0) and after (T1) the implementation of interventions. The Mann-Whitney test was used to compare the VPI values between the groups, and the Student t-test for independent samples was used to compare GBI values. The level of significance was set at 5%. No statistically significant difference was observed between the groups at T0 for both VPI and GBI, and at T1 for the GBI. The manual orthodontic toothbrush produced a statistically lower VPI (P ≤ 0.05) at T1, but this did not seem to be of clinical importance. Descriptors: Orthodontics; Biofilms; Oral Hygiene. Introduction Declaration of Interests: The authors certify that they have no commercial or associative interest that represents a conflict of interest in connection with the manuscript. Corresponding Author: Fábio Henrique de Sa Leitão Pinheiro E-mail: Received for publication on Nov 16, 2011 Accepted for publication on May 09, 2012 360 Preventing dental demineralization requires, among other things, frequent removal of the biofilm that accumulates on the surface of teeth. Simple as it may sound, brushing teeth regularly is a task frequently neglected by some individuals, not to mention the occasions when brushing is not done appropriately. In orthodontics, this problem takes on bigger dimensions as those wearing fixed orthodontic appliances are more susceptible to the accumulation of biofilm than the rest of the population. For these patients, the industry has manufactured a series of hygiene aids ranging from easy-to-use dental floss to orthodontic and interproximal toothbrushes1 as well as electric2,3 and ultrasonic toothbrushes.3-5 There has been quite substantial interest in testing the effectiveness of powered hygiene devices for orthodontic patients. Although part of the positive results must be attributed to the psychological impact of using a relatively sophisticated device, some studies have reported a reduction in Braz Oral Res., (São Paulo) 2012 Jul-Aug;26(4):360-5 Gomes LK, Sarmento CF, Seabra FRG, Santos PBD, Pinheiro FHSL gingival bleeding index (GBI), 2 visible plaque index (VPI), and in the number of Streptococcus mutans in patients using such devices.6 In the midst of the allure of high-tech toothbrushes, studies on the effectiveness of orthodontic manual toothbrushes have had mixed results. A systematic PubMed search of the literature prior to June 17, 2010, combining the descriptors “orthod” and “toothbrush”, produced a total of 68 publications. Among the ones written in English, only five had been designed to compare the performance of conventional and orthodontic manual toothbrushes. None of these studies were split-mouth randomized controlled trials, and two of them had relatively small sample sizes (between 10 and 14 patients). In addition, the comparisons were based on an intraindividual experimental design, thus requiring even larger samples. Of the five selected studies, only one7 observed improved outcomes with the orthodontic manual toothbrush. Considering that this study was published in the 1980’s, and the fact that orthodontic toothbrushes have gone through advancements in bristle design and material, there appeared to be a need for updated, evidence-based studies using more stringent methods. Manual orthodontic toothbrushes are still recommended by practitioners all over the world, primarily because of active marketing by the industry. Unbiased well-conducted trials are necessary to assess the effectiveness, and even the risks, of common brands of orthodontic toothbrushes during orthodontic treatment. This split-mouth randomized clinical controlled trial compared the effectiveness of an orthodontic manual toothbrush (Orthodontic, Oral-B) in relation to a conventional homologous design (Sensitive, Oral-B). This study tested the null hypothesis (H0) that there would be no statistically significant reduction in VPI or GBI with either type of intervention after a follow-up time of 1 month. Methodology This split-mouth, parallel, randomized clinical trial was approved by the research ethical board at Potiguar University according to approval protocol number 297/2009. This study conformed to 2001 CONSORT statement requirements. Patient samples were obtained from a local practice specialized in orthodontic training for postgraduate students. A total of 720 orthodontic records were available for the study. Because 430 patients were already wearing retainers, they were excluded. Of the 290 remaining records, 64 were randomly selected for this study. The inclusion criteria were permanent dentition, no more than 4 mm anterior crowding, fixed orthodontic (multibracket) appliances until the 2nd premolars or beyond, maximum age of 35 years, no remarkable periodontal problems, same type of orthodontic mechanics (modified Tweed-Merrifield technique), and same bracket type (.022 × .028 slot, Roth prescription, Morelli, Sorocaba, Brazil), no enamel defects or restorations involving the buccal surface, no prostheses and good general health. All patients were non-smoking and had not received dental prophylaxis or used oral mouthwashes in the previous 4 weeks. Those being treated with asymmetric extractions were excluded. After initially selecting 56 patients (30 females, 26 males) who fulfilled all of the aforementioned criteria, 8 patients were still needed to comply with the sample size calculation of 64 subjects, based on the statistical parameters (minimal difference between plaque index m (...truncated)