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Efficacy of a Triclosan/Copolymer Dentifrice and a Toothbrush with Tongue Cleaner in the Treatment of Oral Malodor: a Monadic Clinical Trial

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Efficacy of a Triclosan/Copolymer Dentifrice and a Toothbrush with Tongue Cleaner in the Treatment of Oral Malodor: a Monadic Clinical Trial Open Journal of Stomatology, 2013, 3, 63-69 OJST http://dx.doi.org/10.4236/ojst.2013.31012 Published Online March 2013 (http://www.scirp.org/journal/ojst/) Efficacy of a triclosan/copolymer dentifrice and a toothbrush with tongue cleaner in the treatment of oral malodor: A monadic clinical trial Prem K. Sreenivasan1, Violet I. Haraszthy2, Joseph J. Zambon2*, William DeVizio1 1Colgate Palmolive Company, Piscataway, USA 2University at Buffalo, School of Dental Medicine, Buffalo, USA Email: *[email protected] Received 20 January 2013; revised 28 February 2013; accepted 9 March 2013 ABSTRACT 1. INTRODUCTION Aim: Oral malodor (halitosis) is a widespread condi- Oral malodor, also referred to as oral halitosis, is an un- tion caused by oral bacteria, particularly sulfur com- pleasant or offensive odor emanating for the oral cavity. pound-producing species. This study assessed the It is a common world-wide complaint and a significant effect of a triclosan/copolymer-containing dentifrice reason for professional consultation and referrals [1]. and a novel toothbrush with attached tongue cleaner Halitosis is frequently self-diagnosed and is a source of on oral malodor and on the bacteria colonizing the social embarrassment, psychological discomfort, and dorsal surface of the tongue. Materials and Methods: altered behavior and it can influence diet and habits [2,3]. 14 adult subjects with oral malodor defined as orga- It is estimated that 85% of oral malodor originates in the noleptic scores ≥ 3 (scale 0 - 5) and mouth air sulfur oral cavity with the remainder associated with a number levels ≥ 250 ppb participated in this study. Subjects of extra-oral sources including systemic diseases. Thus, were examined at baseline and after 28 days use of oral halitosis represents a multi-factorial problem strad- the triclosan dentifrice and toothbrush/tongue cleaner dling several clinical and scientific disciplines [1,4,5]. for: 1) organoleptic assessment; 2) mouth air sulfur Descriptions of oral halitosis and potential treatments levels; 3) tongue coating; and, 4) dorsal tongue sur- can be traced back to antiquity [6]. Despite a paucity of face microorganisms. Total bacterial numbers were epidemiological studies, halitosis has been reported in assayed by microscopy. Dot-blot hybridization was populations and cultures across the world such as China, used to assess a panel of 20 oral bacteria. Results: Brazil, Israel, Japan, Switzerland and the USA. Further- After 28 days, all subjects had significantly reduced more, it is estimated that approximately 50% of the organoleptic scores and mouth air sulfur levels com- population may suffer from recurring episodes of halito- pared to baseline (p < 0.0001). There was >70% re- sis with clinical symptoms in 75% of examined indi- duction in microbial numbers (p < 0.001) on the dor- viduals [5,7]. Halitosis was reported in approximately sal tongue and significant reductions in Enterococcus one-third of 419 subjects from a randomly selected po- faecalis (p < 0.003), Neisseria sp. (p < 0.008), Pepto- pulation [8]. The overall prevalence of halitosis has led streptococcus micros (p < 0.0007), Prevotella melanino- to its identification as an important social problem [4]. genica (p < 0.02), Porphyromonas gingivalis (p < Based on the effects of halitosis on patient health and 0.0001), Solobacterium moorei (p < 0.04), and Stre- well-being, research has examined the causes of oral ptococci sp. (p < 0.03). Conclusions: Oral malodor malodor. It is now widely accepted that tongue coating was successfully treated in all subjects following 28 represents an important factor with contributions from days use of the triclosan/copolymer-containing denti- other conditions such as periodontitis, gingivitis, caries, frice and toothbrush with a tongue cleaner as deter- oral ulceration and necrosis, and food debris [9]. Micro- mined by significant reductions in clinical measures biological studies indicate proteolytic and other meta- of halitosis and a corresponding reduction in micro- bolic features of some tongue surface microorganisms biological measures including sulfur compound-pro- that facilitate production of volatile sulfur compounds ducing oral bacteria. (VSC’s) resulting in halitosis. Recent clinical investiga- tions utilizing nucleic acid analysis of oral bacteria [10- Keywords: Halitosis; Oral Malodor; Triclosan; Tongue 12] have found distinct microorganisms amongst subjects *Corresponding author. with clinical halitosis. One microorganism, Solobacte- OPEN ACCESS 64 P. K. Sreenivasan et al. / Open Journal of Stomatology 3 (2013) 63-69 rium moorei, was isolated primarily from the dorsal ton- and the sample was placed in 3 ml of pre-reduced, gue surface of subjects with halitosis [10,11] suggesting anaerobically sterilized Ringer’s solution. that this bacterium is closely associated with the etiology Subjects were given a commercially available denti- of oral malodor [1,7]. frice formulated with triclosan/copolymer (Colgate Total) A recent review highlights the lack of clinical studies and a soft-bristled toothbrush with a tongue cleaner. Sub- evaluating the effects of antimicrobials in oral health care jects were instructed in oral hygiene using the sulcular products in conjunction with mechanical cleansing in method. Subjects were instructed to brush their teeth for mitigating halitosis [9]. Triclosan is a substituted phenol at least two minutes—once in the morning after breakfast with an extended history of safe and effective use in oral and once at night before bed—with the assigned tooth- hygiene formulations [13]. A toothpaste formulated with brush and dentifrice. After toothbrushing, they were triclosan/copolymer has been widely evaluated for cli- instructed to use the tongue cleaner on the dorsal and nical efficacy [13,14] and demonstrates significant in- lateral surfaces of their tongue for at least ten seconds. hibitory effects on the bacteria found in dental plaque, in Subjects were instructed to refrain from chewing gum or saliva and on the tongue [15]. The present clinical in- using any other oral hygiene products such as mouth- vestigation evaluated the effects of mechanical tongue wash during the course of the study. cleaning using a specially designed toothbrush with a Post-treatment clinical examinations and sample col- tongue cleaner in conjunction with a dentifrice formu- lections were conducted 28 days later. Dorsal tongue lated with triclosan/copolymer on clinical measures of samples were collected approximately 12 hours after halitosis and on the microbes colonizing the dorsal ton- final use of the assigned toothbrush and dentifrice. A gue surface. dentist conducted an evaluation of oral soft and hard tissue health for each enrolled subject at the conclusion 2. MATERIALS AND METHODS of the study. 2.1. Subjects 2.3. Microbiological Analysis Adult subjects from the Buffalo, NY, USA area were screened for study criteria. The nature of the study was The dorsal tongue bacterial samples were dispersed by explained to prospective subjects who completed and vortexing at maximal setting for 1 min. The number of signed an informed consent statement. Adults with 20 tongue surface bacteria was assayed by phase-contrast natural teeth including at least one molar and one bicus- microscopy as previously described [18]. Dot-blot hy- pid in each quadrant of the dentition, in good oral and bridization was used to enumerate a panel of 20 target general health and who were not undergoing medical oral microorganisms (Table 1) utilizing digoxigenin-11- treatment were scheduled for a baseline visit. Exclusion ddUTP labeled oligonucleotide probes (Genius 5, Boe- criteria included; subjects with dental prostheses, ram- hringer Mannheim, Indianapolis, IN). Dorsal tongue sur- pant caries or other conditions requiring immediate den- face samples were blotted onto charged nylon mem- tal care; subjects who required antibiotic pre-medication branes (Hybond-N, Amersham, Arlington Heights, IL) prior to dental treatment or who had taken antibiotics using 10× standard salt phosphate EDTA buffer (SSPE) within 3 months or who had received periodontal therapy and hybridized with the digoxigenin-labeled oligonucleo- within 6 months. All subjects indicated routine use of a tide probes at the appropriate temperature for each probe. toothbrush and toothpaste and were enrolled based on the Known amounts of each microorganism were included in following inclusion criteria: 1) organoleptic scores of ≥3 the dot blot assays as standards to determine the number on a 5-point scale assessed by a single trained examiner of target microorganisms in each sample with results [16]; 2) halimeter scores ≥ 250 ppb utilizing a portable reported as log counts per ml of sample. sulfide monitor (Halimeter®, Chatsworth, CA); and 3) All chemicals were analytical grade or better. Buffers assessments for tongue coating utilizing a 0 - 5 scale [2, and saline were obtained from Invitrogen, Carlsbad, CA. 17]. Reagents for nucleic acid blotting and labeling were ob- tained from Boehringer Mannheim, Indianapolis, IN and 2.2. Clinical Examinations and Treatments Amersham, Arlington Heights, IL, respectively. After screening, subjects were scheduled for baseline 2.4. Statistical Analysis clinical evaluations for halitosis that included organole- ptic, halimeter and tongue coat assessments. Following Clinical, microscopic and microbiological results from these evaluations, an approximately 2 cm2 area of the the study were each evaluated by paired t-tests with p
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