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The Effect of Four Mouth Rinses on Oral Malodor
Loretta C. Borden, MS Eros S. Chaves, DDS James P. Bowman Barbara M. Fath Consumer Products Testing Division Hill Top Research, Inc. Cincinnati, Ohio Garry L. Hollar Director of Regulatory Affairs Discus Dental, Inc. Culver City, California Abstract The purpose of the study was to compare the efficacy of four mouth rinses in clinical outcomes of changes in oral malodor measurements in a 4-week, randomized, double-blind, longitudinal clinical lariat in adults. The four rinses secret coded as Products 1, 2, 3, and 4 so that neither the examiners nor subjects had the knowledge of treatment. Of the four mouth rinses, two were commercially available mouth rinses with essential oils (EO) or chlorine dioxide plus zinc (CD/Zn) as active ingredients (Products 1 and 4), one mouth rinse was a formulation containing cetylpyridinium chloride (Product 2), and one seas a placebo (Product 3). A total of 99 subjects who met the study criteria were assigned randomly to one of the four groups. At three separate visits (0, 2, and 4 weeks), subjects received an examination of the oral soft tissues and were assessed for baseline oral malodor by two organoleptic judges and a laboratory instrument that measures oral malodor. Subjects were instructed to use the assigned rinse, and the measurements were performed again after 2 and 4 hours. Throughout the 4-week study period, each subject was asked to use the assigned rinse twice daily per the manufacturer's recommended directions. The results showed that the four mouth rinses reduced oral malodor within 4 hours after a single usage, with Product 2 being the most effective and the placebo being the least effective. Daily use of EO, CD/Zn, and placebo rinses for up to 4 weeks did not reduce oral malodor from week 0 baseline ethics, and the effects on oral malodor were comparable among these three mouth rinses. Product 2 was the only mouth rinse that reduced oral malodor from baseline values after 2 and 4 weeks of daily use. Oral malodor, or bad breath, is a generic descriptive term for foul smells emanating from the mouth. It includes ozostomia, stomaxlysodia, halitosis, and fetor odors or fetor, which denotes different sources of oral malodor. It has been estimated that 20% to 60% of the population suffers from chronic oral malodor, and in approximately half of these individuals, the problem becomes serious enough to create personal discomfort and social embarrassment. Oral malodor has also been reported in children 2 to 7 years old and 5 to 14 years old. Because of the potential impact of oral malodor on personal life, sufferers often make desperate attempts to mask their oral malodor with mints and chewing gum, compulsive brushing, and repeated use of mouth rinses. In most cases, the problem of oral malodor has been shown to originate in the oral cavity, where conditions that favor the retention of anaerobic, mainly gram-negative bacteria, lead to the development of bad breath. In addition to periodontal pockets, the most important retention site is the dorsurm of the tongue with its numerous papillae." Volatile sulfur compounds (VSCs), primarily hydrogen sulfide and methyl mercaptan, appear to be responsible for much of the malodor. A number of systemic diseases, such as diabetes mellitus, uremia, and hepatic diseases, may also induce malodor. The recommended initial treatment strategy is to identify the exact cause of the oral malodor, which can be difficult. Oral hygiene, particularly the daily use of a tongue cleaner, can be effective in reducing the risk of oral malodor. Introduction to etiologic therapy, oral care products, including mouth rinses, toothpastes, and chewing gums, may be used to mask the malodor. It has been suggested that products containing metal ions, especially zinc, are effective in inhibiting odor formation because of their neutralizing effect on sulfur compounds. Because of the implication of bacteria in producing malodor, there has been an increasing interest in using antibacterial mouth rinses to control oral malodor. Mouth rinses containing essential oils (EOs), chloride dioxide plus zinc (CD/Zn), or an oil-water-cetylpyriclinium chloride (CPC) combination have been shown to reduce the organoleptic scores of individuals with moderate levels of oral malodor. These results were found in the absence of tongue cleaning, although in several studies the findings are controversial and sometimes contradictory. The purpose of this study was to compare the effect of BreathRx mouth rinse (2) two to commercially available rinses on oral malodor in adults in a 4-week, randomized, double-blind, longitudinal clinical trial. A placebo rinse was also included in the study to serve as the negative control. Materials and Methods The study was conducted according to applicable Good Clinical Practices and Standard Operating Procedures of Hill Top Research, Inc. Before conducting the study, protocols and pertinent documents were submitted and approved by an Institutional Review Board (IRB) in accordance with Title 21 of the Code of Federal Regulations, Parts 50 and 56. An informed consent letter was pro-vided to and signed by each of the study participants before the initiation of the project. There was one amendment to the consent form, which was submitted and approved by the IRB before the recruitment of subjects. The amendment informed the subjects that they would be required to stay at the study site for approximately 6 hours instead of 5 hours. The four test mouth rinses were provided by the study sponsor in coded, identical packages as Product 1, 2, 3, and 4 so that neither the examiners nor the subjects had the knowledge of treatment. They were: 1. Listerine@ Antiseptic Rinse', a commercially available, EO-based rinse (Product 1). 2. BreathRx'" Mouth rinse, a formulation containing CPC (Batch # BTM-008A) (Product 2). 3. A placebo rinse (Batch c BTM-007P) (Product 3). 4. Oxygen' Mouthwash with Zinc`, a com- Commercially available, CD/Zn-based rinse (Product 4). The repackaging of the EO-based rinse was performed using good manufacturing practice procedures. The CD/Zn rinse was left in the original manufacturer's sealed bottle with the label covered over. To obtain a study population that represented typical users of the test mouth rinses, study subjects were recruited from local communities. Potential subjects were interviewed by phone and screened for their eligibility to participate in the study according to the following inclusion criteria: 1. In good general health based on medical history and oral soft tissue examination. 2. A man or woman between 18 and 65 years of age. 3. Willing to sign the informed consent form and comply with the protocol procedures. 4. Two-judge average intensity score of 4 on a scale of 5 and no single score of < 3. 5. Minimum of 16 natural teeth, including at least 4 molars. 6. Availability of the subject to complete the 4-week study. Any subject with one or more ok the following conditions were excluded: 1. Gross oral pathoses that the investigators thought may compromise the protocol. 2. Orthodontic devices. 3. Partial or complete dentures. 4. Any systemic disease that the investigators thought may interfere with the study. 5. History of irritation or sensitivity to oral products. 6. Pregnant or lactating women as determined by medical history. 7. Periodontal disease (pocket depth > 4 mm and/or bleeding on probing 6 sites but: nonadjacent) or gross neglect of oral hygiene. 8. Smokers. 9. Prophylactic antibiotic coverage for routine dental therapy. 10. Use of systemic antibiotics or prescription mouthwash 21 clays before the study. 11. Current participation in other dental or investigational trials. 12. Patients on concomitant drug therapy were not included in the study based on the discretion of the investigator/examiner. 13. Library = alcohol infuse. l4. Evidence of a recent history of bronchitis, tonsillitis, or sinusitis. In addition, subjects were excluded from the sturdy if they received emergency dental treatment or if loss of teeth placed them below the minimum teeth requirements. Any subject treated with antibiotics or antibacterial agents during the course of the study were also dropped. Subjects were instructed to refrain from routine dental treatments, except for emergencies, for the duration of the study. Qualified subjects were randomly assigned to one of the four groups, each with a minimumber of 20 subjects. The subjects were asked to use the assignee) mouth rinse twice daily following the supplied instructions for use. They were provided with standard fluoride toothpaste and standard soft toothbrushes, and were required to not use any other dental crevices or products during the study period. It was recognized that subject compliance was essential and imperative to the reliability and accuracy of the clinical data. To maximize the compliance, the investigators reviewed and emphasized the instructions with each subject. Compliance was also monitored by reviewing daily logs of each subject's mouth rinse use along with quantification of the remaining mouth rinse returned at each visit. A medical history was collected from each accepted subject. At each of the three visits (0, 2, and 4 weeks), subjects received an oral soft tissue examination and were assessed for base-line oral malodor by two organoleptic judges and a laboratory instrument that measures oral malodor (Halimeter). The oral soft tissue examination included observations of the lips, buccal mucosa, floor of the mouth, tongue, hard and soft palate, and gingiva. All findings were recorded as normal or abnormal. All abnormal findings, such as signs of sloughing, erythema, ulceration, or edema, were recorded and described on the evaluation form. Each parameter was scored as normal, mild, moderate, or marked. The subject was then instructed to use the assigned rinse, and the organoleptic measurements were performed after 15 minutes, 7. hours, and 4 hours, respectively. Halimeter measurements were performed after 2 and 4 hours. The organoleptic measurements were performed independently by two experienced, calibrated judges. The subjects were instructed to close their mouths for 2 minutes and to not swallow during that period. The subjects were then asked to breathe out gently, at a distance of 10 cm from the nose of the organoleptic judge, and the organoleptic odors were assessed according to a 5-point scale: 0 = No odor present. I = Barely noticeable odor. 2 = Slight but clearly noticeable odor. 3 = Moderate odor. 4 = Strong offensive odor. 5 = Extremely foul odor. The Halimeter (Model RF I-17K) was balanced with a zero reading and, to ensure the accuracy of each reading, the measurements follow. l the manufacturer's instructions. For the mouth reading, the short end of a flexible drinking straw was inserted approximately 1/2 inch into the subject's slightly parted lips, which were gently touching the straw. The subjects were instructed to hold their breath for 5 to 10 seconds until a peak in VSCs was reached. Readings for the VSCs were then recorded. For the throat and posterior tongue, the drinking straw was inserted approximately 3 inches into the subject's mouth near the throat. The subjects were instructed to hold their breath for 5 to 10 seconds, and the VSC reading was recorded. For the nasal passage/sinus, the straw was inserted 1/2 inch to 1/8 inch. Subjects were instructed to hold their breath 5 to 10 seconds, after which time the VSC value was recorded. For data analyses, mean organoleptic and Halimeter scores as well as the mean and percent changes from week 0 baseline to weeks Zinc 4 baselines were calculated. The within-treatment data were analyzed using the Wilcoxon signed rank test. For the between-treatment analyses, Kruskal-Wallis contingency table technique was used. When statistically significant differences were detected, multiple comparison tests were performed to determine differences among products. Results A total of 138 subjects were recruited anal signed the consent form. After screening examinations, 99 subjects who met the study criteria were enrolled and completed the first visit (week 0). Three subjects were disqualified as result of a low organoleptic score of 2 and one subject withdrew consent after completing the first visit. Therefore, data collected from 95 subjects, including 29 men and 66 women who ranged in age from 19 to 65 years, were included in the analysis. A total of 209 bottles of mouth rinses were distributed to the subjects, and four bottles (two for Product 1/EO and one each for Products 3/Placebo and 4/CD/Zn) were not returned. Two subjects inadvertently discarded three bottles. No specific reason was given for the other missing bottle. As indicated by subjects' diaries, all 95 subjects used the assigned mouth rinse according to instructions on the label and met the compliance criteria. The product usage was relatively even among subjects in the four product groups. Eleven subjects missed between one and five at-home rinses; however, it is the authors' opinion that these deviations did not affect the outcome of the study. There were 13 adverse events, including lip blisters, localized gingival edema, and canker sores, reported by 13 subjects during the course of the study. One subject was hospitalized with cellulitis, which was determined to be nonrelevant to the mouth rinse used. The subject was treated for her condition and was discontinued from the study. After careful evaluation, it was determined that these Organoleptic Measurements. The average baseline organoleptic scores at the initiation of the study were 4.14 for Product 1/EO, 4.22 for Product 2/CPC, 3.93 for Product 3/placebo, and 4.02 for Product 4/CD/Zn. The values are not statistically different, indicating that the initial average level of oral malodor was balanced among the four groups. The organoleptic scores from baseline, 15-minute, 2-hour, and 4-hour evaluations after a single rinse with four test mouth rinses at weeks 0, 2, and 4 are summarized in Tables 1 through 3, respectively. The within treatment analyses using Wilcoxon signed rank test evaluated the changes from baseline at each visit. Mean changes and percent changes from baseline at each visit were also calculated. The data showed significant decreases in oral malodor for all of the rinses at all post-treatment evaluations except the placebo at the +hour evaluation in weeks 0 and 4 (Tables 1 and 3). The baseline organoleptic data from weeks 0, 2, and 4, which were collected before the use of the rinses, were further analyzed and the results showed that Product 2/CPC was the only mouth rinse that significantly reduced oral malodor after twice daily use for 2 and 4 weeks. The other three mouth rinses did not have a significant effect on the baseline organoleptic data obtained from weeks 2 and 4 compared to week 0. Product 2/CPC was comparable to Product 4/CD/Zn in reducing the organoleptic score at the 15-minute and 2-hour evaluations; however, Product 2/CPC was significantly more effective than the placebo and Product 1/EO. At the 4-hour evaluation, the reduction of organoleptic scores observed in the subjects using Product 2/CPC was significantly higher (P < .05) than the subjects using the other three rinses. Further analysis of the baseline organoleptic data from weeks 0, 2, and 4, which were collected before the use of the rinses, showed that Product 2/CPC was the only mouth rinse that reduced oral malodor after twice daily use. Halimeter Measurements Tests for normality were conducted on the Halimeter data, and the results indicated that the data were not normally distributed. Therefore, nonparametric methods were used for data analyses. The average baseline Halimeter mouth readings at the initiation of the study were 89 for Product 1/EO) 8.8 for Product 2/CPC, 88.1 for Product 3/placebo, and 73.3 for Product 9/CD/Zn. For throat readings, the initial average baseline readings were 98.2 for Product 1/EO, 136 for Product 2/CPC, 106 for Product 3/placebo, and 99.7 for Product 4/CD/Zn. No attempts were made to balance the initial Halimeter baseline values, as the organoleptic score was the primary parameter for group balancing. While the Halimeter values, particularly those from throat, appeared to vary among the groups, they were not statistically different. Because of possible interference to the performance of the Halimeter immediately after the use of mouth rinses, these measurements were performed at 2 and 4-hour evaluation after the rinse. The within-treatment analysis of the Halimeter data from the front of the mouth found significant decreases in scores (P < .05) with all of the products at the 2- and 4-hour evaluations in week 0. In addition, Product 2/CPC showed significant decreases in Altimeter readings (P < .05) at the 4-hour evaluation in weeks 2 and 4, while Product 1/EO showed significant decreases (P < .05) at the 4-hour evaluation in week 2 and the 2-hour evaluation in week 4. The within-treatment analysis of the Halimeter data obtained from the throat inclicatec1 significant decreases with Product 1/EO at both evaluations in week 0 and in the 2-hour evaluation in week 4 (I < .05). Significant reduction (P < .05) was also observed in Product 2/( PC at both the 2- and 4-hour evaluations in weeks 0 and 2 and at the 4-hour evaluation in week 4. Product 4/CD/Zn rinse was found to significantly reduce (P < .05) the Halimeter readings at the 2- and 4-hour evaluations in week 0. There were no significant differences in Halimeter readings obtained from the mouth among the four rinses, regardless of the measurements taken at the 2- and 4-hour evaluations after a single rinse at each visit or the base-line values after 2 and 4 weeks of twice daily use. Significant differences were detected from the Halimeter data that was obtained from the throat at the 2-hour evaluation. Products 1/EO, 2/CPC, and 9/C L)/Zn resulted in significantly greater reductions from baseline Halimeter readings than the placebo rinse (P < .05) (Table 9). Numerically, Product 2/CPC induced the greatest reductions among the four rinses, although the differences were not significant with Products I/EO and 4/CD/Zn at the 2-hour evaluation and with the other three rinses at the 4-hour evaluation (Table 9 and Figure 3). Significant differences among products were also detected in the reduction of Halimeter measurements obtained from the throat at the week 2 evaluation. Product 4/CD/Zn showed significantly larger baseline differences from week 0 baseline than Product 3/placebo (Table 10). However, the greatest numerical reductions were again observed with Product 2/Chart both the 2- and 4-week evaluations (Table 10 and Figure 4). Discussion Oral malodor is a multi-etiological condition. While certain systemic diseases can cause oral malodor, the majority of sufferers may have a local cause in the oral cavity. An increasing volume of research has shown that certain oral flora, particularly gram-negative anaerobes from the tongue or periodontal areas, are the main microorganisms capable of releasing VSCs from their proteolytic activity of debris and other materials. VSCs are particles of gases that are considered primarily responsible for oral malodor. Mouth rinses have increasingly become an important option in the treatment of oral malodor. The use of mouth rinses was initially considered for cosmetic purposes, and their effects on oral hygiene were believed to be transitory. However, in 1986, the Council on Dental Therapeutics of the American Dental Association established guidelines for the acceptance of chemotherapeutic products for the control of dental plaque and gingivitis." Antimicrobial mouth rinses are now considered an integrated part of daily dental hygiene practice. EOs and CI3/Zn are the active ingredients commonly used in mouth rinses for the treatment of oral malodor. BreathRx'" mouth rinse (Product 2/CPC in the present study) is a formulation containing C:PC, EOs, and C'I)/Zn. The two commercial mouthrinses, which were included in the study for the purpose of comparison, contain either EOs or chloride dioxide and CD/Zn as active ingredients. Although oral malodor is a common problem, there is still a lack of reliable means for its objective measurement, The Halimeter is a specialized device available to measure VSCs in the mouth; however, its accuracy and reliability have been questioned. In addition, the correlation ( oral malodor may not he limited) to VSC's the measurements may not be completely reflective of clinical situations. There are, a number of investigators have suggests that in practice the objective assessment of malodor is still best judged by the human sense of smell (i.e., the organoleptic method). In the present study, both the organoleptic method and Halimeter measurements were used for the evaluation of oral malodor. The organoleptic evaluation was per-formed by two experienced, calibrated examiners and served as the primary parameter for the evaluation of oral malodor. With the secondary data obtained from the Halimeter measurement, the methods for evaluating oral malodor used in this particular study were appropriate and adequate. The data obtained at each of the three visits indicated that a single use of the mouth rinses was effective in significantly reducing oral malodor for up to 4 hours. This finding is in agreement with that reported by a previous study in which a single use of a CD/Zn mouth rinse significantly reduced mouth odor intensity for at least 4 hours. While possible therapeutic efficacy may not be completely ruled out, the reduction of oral malodor up to 4 hours after a single rinse may largely be a masking effect, as the placebo rinse was also effective. In addition, the mechanical cleansing of the oral cavity during the rinse may also help temporarily reduce the odor. However, the significant reductions of oral malodor over the course of 4 weeks in subjects using BreathRx mouth rinse may not be attributed to the masking effect. The most effective and the placebo rinse the least effective. The daily use of the two commercial mouth rinses EO or CD/Zn as active ingredient and the placebo rinse for up to 4 weeks did not reduce oral malodor from week 0 baseline scores. Product 2 with CPC (BreathRx) was more effective than the other three mouth rinses in reducing oral malodor. |
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