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J Periodontal March 2005
Efficacy of Chlorhexidine Mouth Rinses with and Without Alcohol: A Clinical Study Background: Plaque control is the main method for preventing periodontal diseases. Chlorhexidine digluconate mouth rinse is widely recognized as helping to maintain plaque control. Most of these mouth rinses contain alcohol, making them impractical for many patients, including those with oral mucosal hypersensitivity. Mouth rinses without alcohol might cause fewer side effects, but also be less efficient. In this study, we evaluated the efficacy of a 0.12% chlorhexidine mouth rinse without alcohol against one with 11 % ethanol and a placebo. Methods: This a double-blind, parallel group study with 96 patients who tested 3 mouth rinses containing 1) chlorhexidine digluconate 0.12% sodium fluoride 0.05%, and ethanol 11 % (group 1; CHX-A); 2) the same solution without alcohol (group 2; CHX-NA); and a placebo (group 3; P). Plaque and bleeding indexes were recorded in all patients prior to treatment and at 14 and 28 days. Results: There were significant differences in plaque, gingivitis, and papilla bleeding indexes in both chlorhexidine rinses compared to placebo, but no differences between the 2 CHX products. Conclusions: In this study, the alcohol-free rinse was as effective as one containing alcohol in controlling plaque and reducing gingival inflammation. Therefore, it would seem that its use can be recommended in all patients, but especially in patients for whom the use of alcohol is contraindicated. KEY WORDS Chlorhexidine/therapeutic use; dental plaque/prevention and control; comparison studies; gingivitis/prevention and control; ethanol/metabolism. Plaque control using mechanical means (tooth brushing and flossing) and chemical methods have been the primary preventive measures. Since mechanical means alone have limitations, attention has been given to chemical agents.1 Mouth rinses have been shown to be of considerable help in controlling plaque, particularly supragingival plaque, as adjuncts to mechanical means. Although there are a wide range of products recognized as efficacious in preventing plaque formation and gingivitis, it is widely accepted that the most effective are those containing chlorhexidine digluconate 0.12%.4-6 However, these mouth rinses produce undesirable side effects such as staining and taste distortion, which are not acceptable to many patients. A preliminary study reported that alcohol-free mouth rinses cause less patient pain than those containing alcohol.]2 It is accepted that tobacco and alcohol are 2 risk factors for oropharyngeal cancer; however, the association between cancer and the use of alcohol-containing mouth rinses is still being evaluated. Alcohol is used in mouth rinses as a dissolvent of other ingredients and as an antiseptic agent. Its presence in mouth rinses is detrimental to patients with mucositis, who are immunocompromised, or are sensitive to the ingredient. Its use is also contraindicated in patients undergoing radiation therapy for head and Neck cancer. The development and use of alcohol free mouth-rinses are relatively new. Certain studies have shown their efficacy and lack of side effects, 5 but there is no clear confirmation.21 The aim of the present study was to evaluate the efficacy of an alcohol-free CHX mouth rinse to the same preparation with 11 % ethanol and a placebo. MATERIALS AND METHODS Study Population: The study included 97 patients (37 men and 60 women; average age 35 years) who attended the periodontics clinic at the Faculty of Medicine and Dentistry at the University of Santiago de Compostela and 3 local private practices. More patients were placed in the placebo group because our experience indicated that participants in this group are more likely to exit a study; in this study, however, the only patient who failed to complete the study was in the CHX-NA group. The inclusion criteria were ages 25 to 50 years and a minimum of 22 teeth. Exclusion criteria were adverse reaction to chlorhexidine, antibiotic therapy, diabetes, pregnancy, tactation, or tooth brushing 4 times a day. Patients were informed of the nature of the study and gave informed consents. Medical histories, including current and past diseases and conditions, current medications and a dental history including tooth brushing frequency were taken. This was a double-blind study with 3 parallel groups using 3 different solutions from the same firm: 0.12% chlorhexidine digluconate, 0.05% sodium fluoride. and 11 % ethanol (group 1; CHX-A); the same CHX formulation without the ethanol (group 2; CHX-NA); and a placebo. Baseline plaque and papillary bleeding index26 were recorded and patients assigned to 1 of 3 groups balanced for age and gender; there were no differences between the initial mean values of the clinical indexes. Patients were instructed to rinse for 30 seconds with 10 ml of their undiluted mouth rinse once a day for 27 days and to refrain from eating or drinking for 1 hour afterward. They were also instructed to brush 3 times a day with the dentifrice and brush of their choice at least 30 minutes before using the mouth rinse to avoid possible pharmacological interactions. They were instructed not to use any other dental hygiene products during the study period. PI and PBI were recorded at 14 and 28 days; both examiners and patients were blinded to the mouthwash used. Statistical Analysis: Analysis of variance (ANOYA) with Scheffe and Games-Howell tests for independent variables and Student t test for related variables were used for PI (nor- . mal distribution: Z = 1.26; P = 0.082). Since the Kotmogorov-Smirnov test did not fit normal distribution (Z = 1.38; P = 0.082) for PBI, the Kruskal-Wallis, MannWhitney for 2 independent samples, and Friedman ANOYA for K-related samples were carried out for independent K samples. Cross-tabulation and chi square test of independence were used to examine relationships among the categorical variables. All tests were carried out using a statistical software program. P <0.05 was considered statistically significant unless otherwise indicated. RESULTS: The mean PI and PBI values were reduced in all groups; however, there were statistically significant differences. The difference in PI after 14 days in the CHX groups (1 and 2) compared to placebo was 0.5728 and 0.6639 (P = 0.001), indicting a greater plaque reduction with the CHX rinses. However, the difference (0.091]) between the CHX groups (] and 3) was not statistically significant. At 28 days, the difference between the CHX groups and placebo was significant (P= 0.011 and P= 0.001), while there were no differences between the 2 CHX solutions. In groups 1 (CHX-A) and 2 (CHX-NA), differences between the baseline and 28-day scores were significant (P= 0.021; P= 0.0001, respectively) while in the placebo group (3) there was no difference between the time points. Side Effects: All patients using chlorhexidine mouth rinses showed some degree of staining, which did not occur in the placebo group. The most frequently reported reactions were apthaes, burning sensation, and foaming. Except for staining, there was no correlation between the side effect and the mouth rinse. DISCUSSION: Several studies indicate that chlorhexidine has properties that make it a suitable anti plaque agent. However, it does have undesirable side effects, primarily staining and taste distortion which limits its long-term use. It should be noted that none of our CHX patients reported taste distortion as a problem. In this study, we tried to determine whether chlorhexidine maintains its beneficial effects without alcohol by comparing 2 CHX mouth rinses with and without alcohol and a placebo on patients with similar baseline PSI and PI values. Our results indicate that CHX mouth rinses, with or without alcohol, reduce plaque levels, which is similar to other studies. We should note that in our study, unlike that of Eldridge where all other oral hygiene was discontinued, our patients continued their normal tooth brushing habits. This is important as it has been suggested that the efficacy of CHX rinses may vary depending on whether or not they are used in conjunction with toothpaste. 3 groups was expected, due to the patients' motivation to maintain good oral hygiene. Since our patients were matched for age and gender, it is likely that the effects of tooth brushing were analogous; however, a randomized controlled trial is needed to eliminate differences in oral hygiene to account for our findings We noted no differences in clinical indexes in group 1 (CHX-A) between 14 and 28 days when, in theory, there might have been less motivation to maintain oral hygiene as initial enthusiasm in participating in a clinical trial waned and the effect of the mouth rinse became more obvious. However, we did notice continual changes in the CHX-NA group. This could be interpreted as meaning that mouth rinses with alcohol, itself an antiseptic agent, have a faster effect on PI and PSI than non-alcoholic solutions. However, it should be remembered that, although there was no statistically significant difference in baseline plaque levels, those of the CHX-NA group were slightly higher, which would favor a continual reduction. Gingival bleeding was reduced in all patients who use CHX, while it remained basically unchanged in the placebo group. These data coincide with previous studies. As with Eldridge et al., we observed no differences in the effects of mouth rinses, with or without ethanol, in reducing gingival inflammation. Staining problems with chlorhexidine have been published in a number of studies I and all our patients using CHX rinses reported this side effect on their teeth and/or tongues. Excluding discoloration, there were no differences in side effects among the 3 mouth rinses. CONCLUSIONS: The data in this study gathered from patients with gingival and periodontal disease at baseline confirm previous studies and indicate that the use of CHX mouth rinses is effective for plaque control and in reducing gingival bleeding. Within the limitations of this study, we have shown that alcohol-free chlorhexidine mouth rinses are as effective as those with alcohol for controlling microbial plaque and reducing gingival inflammation. For this reason, they should be recommended for patients for whom alcohol use is not acceptable or contraindicated, as well as patients with oral lesions where alcohol could cause pain. |
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