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ORIGINAL RESEARCH
Year : 2016  |  Volume : 7  |  Issue : 4  |  Page : 137-141

Comparison of the Efficacy and Side Effects of Chlorhexidine Mouthrinses with (Hexidine) and without (Epimax) Alcohol


1 Dental Implants Research Center and Department of Periodontics, School of Dentistry, Isfahan University of Medical Science, Isfahan, Iran
2 Department of Oral and Maxillofacial Radiology, School of Dentistry, Isfahan University of Medical Science, Isfahan, Iran
3 Department of Endodontics, School of Dentistry, Isfahan University of Medical Science, Isfahan, Iran

Date of Web Publication21-Dec-2016

Correspondence Address:
Jaber Yaghini
Dental Implants Research Center and Department of Periodontics, School of Dentistry, Isfahan University of Medical Sciences, Isfahan
Iran
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2155-8213.195971

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  Abstract 


Introduction: Chlorhexidine mouthrinses have widely been recognized for their contribution in maintaining plaque control. Most of them contain alcohol that makes them impractical for many patients. Alcohol-free mouthwashes may have fewer side effects but may be less efficient. The current study was aimed to compare the effectiveness and side effects of chlorhexidine mouthrinses with and without alcohol.
Materials and Methods: In this double-blind clinical trial, 32 patients with moderate and severe gingivitis were recruited. For all patients, full prophylactic procedures, such as removal of plaque, calculus, and stains on the teeth, were performed. Each patient was asked to use 15 mL of the mouthrinse for 60 s twice daily. The patients were divided into two groups, one group used Hexidine (0.12% chlorhexidine and 10% ethanol) mouthwash and the other group used Epimax (0.12% chlorhexidine and 0.05% sodium fluoride) mouthwash. After 14 days, plaque (PI), gingival (GI), and stain indices were analyzed. The obtained data were analyzed by using SPSS 16 using covariance [Analysis of covariance (ANCOVA)] and t-test.
Results: Both mouthwashes significantly reduced the mean scores of plaque (P < 0.0001) and gingival (P < 0.032) indices after 2 weeks; however, Hexidine mouthrinse was shown to be more effective. The extent of stain was the comparable in both groups. While Epimax mouthrinse caused severe stains on the teeth, Hexidine mouthrinse caused burning mouth.
Conclusion: Although Epimax mouthwash did not show any side effects, it was less suitable and caused more dental stain. Ethanol-free Hexidine mouthwash seems to be more proper for gingivitis, but its side effects are required to be taken into consideration.

Keywords: Chlorhexidine, Epimax, Hexidine, plaque index (PI), gingival index (GI), stain index


How to cite this article:
Mogharehabed A, Behfarnia P, Nasri N, Iranmanesh P, Gholami SA, Yaghini J. Comparison of the Efficacy and Side Effects of Chlorhexidine Mouthrinses with (Hexidine) and without (Epimax) Alcohol. Dent Hypotheses 2016;7:137-41

How to cite this URL:
Mogharehabed A, Behfarnia P, Nasri N, Iranmanesh P, Gholami SA, Yaghini J. Comparison of the Efficacy and Side Effects of Chlorhexidine Mouthrinses with (Hexidine) and without (Epimax) Alcohol. Dent Hypotheses [serial online] 2016 [cited 2017 Mar 24];7:137-41. Available from: http://www.dentalhypotheses.com/text.asp?2016/7/4/137/195971




  Introduction Top


Oral health has great impact on for prevention of oral diseases. Therefore, people have used different methods to promote their oral health, among which mechanical techniques such as flossing and brushing, are the most well-known ones. However, these methods are not able to eliminate all disease-causing factors alone, especially in interproximal areas.[1] On the other hand, many people with specific physical and psychological conditions are required to use an antiseptic in order to do away with many deficiencies of eliminating the mechanical plaque. Thus, using chemical materials (such as mouthrinse), are taken more into account. As an aid along with mechanical plaque control, mouthrinses play a pivotal role in supragingival plaque control and gingivitis control.[2] An appropriate mouthwash, in addition to antimicrobial spectrum, should have low pharmaceutical interaction and cause less damage to the normal microflora of oral cavity.[3]

Chlorhexidine (CHX), C22H30Cl2N10, is a basic guanidine-free antiseptic solution with long-lasting effect and bactericidal properties that has been approved by the American Dental Association as a mouthrinse. It is prescribed extensively in Iran to control microbial plaque[4] and its efficacy in prevention of periodontal diseases and chemotherapy-induced stomatitis has been indicated in many studies.[5],[6],[7],[8],[9]

Most mouthrinses in the market contain alcohol. Generally, alcohol is added to mouthrinses for two reasons:

  1. Dissolving other components and
  2. Adding antiseptic properties.[10]


However, adding alcohol to mouthrinses is accompanied by side effects, too. The mouthwashes containing >10% ethanol cause pain in oral mucosa.[11] It has been reported that daily use of mouthwashes with >25% ethanol increases the risk of oral cancer dramatically.[12] Some researchers have shown that alcohol increases the abrasion of composite and resin restorations.[13] Using mouthrinses containing ethanol is forbidden in the patients with mucositis, the patients with sensitive mucosa due to head and neck radiotherapy, the patients with immune deficiency, and the people with allergy to alcohol.[11],[12],[14],[15] Hence, given the side effects presented for the presence of alcohol in mouthwashes, the idea of using alcohol-free mouthrinses has been proposed.[16] Moreover, since ethanol plays a major role in mouthrinses, there exist concerns about the removal of alcohol from mouthwashes. Although some studies carried out in recent years have shown that the clinical and antimicrobial properties of chlorhexidine mouthrinses containing alcohol are not different than that of alcohol-free mouthrinses or are better than placebo mouthwashes.[1],[2],[17]

Eldridge et al. (1998) compared the efficacy of ethanol-free 0.12% chlorhexidine mouthwash, as an antimicrobial solution, with 0.12% chlorhexidine mouthrinse containing ethanol and essential oil. They reported that ethanol-free chlorhexidine was as effective as ethanol-based chlorhexidine mouthwash in reducing streptococcus mutans.[1] Also, Arweiler et al. (2001) compared the clinical and antibacterial properties of ethanol-free mouthwash with CHX and a placebo mouthwash. They concluded that ethanol-free mouthrinse reduced accumulation of plaque biofilm compared with placebo solutions.[17]

Further, Quirynen et al. (2001) compared the effect of four 0.12% chlorhexidine mouthrinses with different formulas on plaque. They reported ethanol-free 0.12% chlorhexidine containing 0.05% cetylpyridinium chloride (CPC) as an antiplaque and anti-inflammation mouthrinse with minimum side effects.[16] Moreover, Borrajo et al. (2002) performed a clinical trial and compared the antiplaque efficacy of two mouthwashes, 0.12% chlorhexidine with and without alcohol. Their results showed that alcohol-free mouthwash was as effective as ethanol-based mouthwash in controlling the plaque and reducing inflammation. Furthermore, Van Strydonck et al. (2005) analyzed the effect of two types of chlorhexidine, alcohol-free 0.12% chlorhexidine containing 0.05% CPC and ethanol-based 0.2% chlorhexidine, on plaque control. They indicated no significant difference between the two types of chlorhexidine; however, ethanol-free chlorhexidine was better in terms of taste but its taste remained longer in the mouth.[18]

Epimax is a new kind of mouthrinse with 0.12% chlorhexidine that has been distributed in Iranian market since several 2 years ago. The manufacturers of this solution have claimed that it has significant antimicrobial properties with minimum side effects. The present study was aimed to compare the plaque control, periodontal efficacy, and side effects of ethanol-free Epimax mouthwash, containing 0.12% chlorhexidine, and ethanol-based 0.12% chlorhexidine mouthrinse.


  Materials and Methods Top


Ethical approval

This randomized clinical trial was approved by the Ethical Committee of the Isfahan University of Medical Sciences (#392408) and Iranian Registry of Clinical Trials (#201402164877N18). Also, informed consent was taken from all patients.

Patient recruitment

In this double-blind clinical trial, 32 patients, coming to the Department of Periodontal diseases at the School of Dentistry, Isfahan University of Medical Sciences, were selected through convenience sampling method. The inclusion criteria were patients with moderate to severe gingivitis, lack of systemic diseases, pregnancy, allergy to mouthrinses, smoking, and using antibiotics or anti-inflammatory drugs in the past 6 months.

Study design

The study was carried out as a double-blind clinical trial. Therefore, the tubes were encoded by a third person such that the patient and researchers were blind to their contents. The coded tubes were then randomly given to the patients; one group (N = 16) received A mouthrinse (Epimax) and another group (N = 16) received B mouthrinse (chlorhexidine). The patients were explained how to use the mouthwashes according to the manufacturers’ instructions; 15 mL of each mouthwash for 60 s twice a day, with interval of 12 h for 2 weeks.

Interventions

After instruction, the patients in both groups were asked to use common plaque control techniques, such as brushing and flossing, during the use of mouthrinses. They were also recommended to use the mouthrinse 1 h after brushing in order to avoid interference with the use of the toothpastes containing sodium lauryl sulfate. After a 2-week period, the patients were visited again.

Materials

The materials used in this study included Epimax mouthrinse, ethanol-free 0.12% chlorhexidine (Emad pharmaceutical CO, Isfahan, Iran), and Hexidine mouthrinse, ethanol-based 0.12% chlorhexidine (Donyaye Behdasht Laboratories CO, Tehran, Iran).

Data collection

Before doing any treatment, the gingival index (GI) and plaque index (PI) were recorded by Loe index and O’leary index, respectively. Then, primary prophylaxis, scaling and root planning, was performed to remove the germs, debris, and external stains. After using both mouthrinses, the GI and PI were evaluated by Loe and O’leary indices, respectively. Lobene index was used to analyze the stain index. The side effects, including changes in taste, allergy, and burning mouth, and parotid swelling were recorded in a checklist.

Statistical analysis

The obtained data were analyzed by SPSS 16 (SPSS Inc. Released 2007. SPSS for Windows, Version 16.0. Chicago, SPSS Inc.) using covariance [Analysis of covariance (ANCOVA)] and t-test.


  Results Top


A total number of 32 patients with moderate-to-severe gingivitis, aged 20-35 years, were investigated in this study. The mean PI before using the mouthrinses in Epimax group (ethanol-free) was 25.36 and in Hexidine group (ethanol-based) it was 22.38. Also, the means of PI after using the mouthrinses in Epimax (ethanol-free) and Hexidine (ethanol-based) groups were reported to be 21.95 and 13.28, respectively. The results of ANCOVA indicated a significant difference between the mean PI before and after the use of mouthrinses (P-value <0.0001) [Table 1].
Table 1 Means ± Standard deviation of plaque and gingival indices before and after the use of mouthrinses

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The means of GI before the use of mouthwashes in Epimax (ethanol-free) and Hexidine (ethanol-based) groups were 16.98 and 22.11, respectively. Further, the means of GI following the use of mouthrinses in Epimax (ethanol-free) and Hexidine (ethanol-based) groups were 9.11 and 7.41, respectively. The findings of ANCOVA test showed a significant difference between mean GI before and after the use of mouthrinses (P-value 0.032) [Table 1].

The extent of stain, assessed by Lobene index, after using the mouthrinses in both Epimax and Hexidine groups was almost the comparable, equal to gingival one third. The results of t-test showed no significant difference between mean extent index before and after the use of mouthrinses (P-value =0.387). The means of stain intensity by Lobene index after using mouthrinses in Epimax and Hexidine groups were 0.62 and 0.39, respectively. There was a significant difference for mean intensity index after the use of both mouthwashes (P-value <0.0001) [Table 2].
Table 2 Means of Loben’s extent and intensity indices after the use of mouthrinses

Click here to view


Seven patients in Hexidine group were seen to have side effects such as discomfort and burning mouth. No side effects were reported in the patients in Epimax group.


  Discussion Top


Chlorhexidine is widely prescribed as a mouthwash for microbial plaque control.[4] Its efficacy in prevention of periodontal diseases and chemotherapy-induced stomatitis has been recognized by numerous studies.[5],[6],[7],[8],[9] However, the presence of alcohol in chlorhexidine mouthwash is accompanied by side effects, too. The present study was an attempt to compare the plaque control, periodontal effectiveness and side effects of ethanol-free 0.12% chlorhexidine (Epimax) and ethanol-based 0.12% chlorhexidine (Hexidine).

The results of this study showed that the mean PI in both Hexidine and Epimax groups was reduced after the use of mouthrinses. According to [Table 1], Epimax (ethanol-free) mouthwash reduced the PI, which is in line with the results of previous studies.[1],[2] Arweler et al. compared the effectiveness of four ethanol-free mouthrinses, amine fluoride/stannous fluoride (ASF) containing 250 ppm fluoride, ethanol-free 0.1% chlorhexidine, 0.02% triclosan, and 0.15% triclosan mouthrinses, with a placebo mouthrinse during 4 days. They reported that ethanol-free mouthrinses reduced the accumulation of plaque biofilm.[17] Further, Van Strydonck et al. compared the ethanol-free 0.12% chlorhexidine containing CPC with ethanol-based 0.2% chlorhexidine in a three-day period. Their results showed no significant difference for PI reduction in both groups.[18] Moreover, Quirynen et al. indicated that 0.12% chlorhexidine containing ethanol-free 0.5% CPC and ethanol-based 0.12% chlorhexidine prevented the formation of new plaque similar to ethanol-based 0.2% chlorhexidine and better than 0.12% chlorhexidine containing ethanol-free sodium fluoride.[16]

Ethanol-based chlorhexidine mouthrinses decreased PI. Various studies have confirmed the efficacy of ethanol-based chlorhexidine mouthwash in plaque reduction[2],[19],[20],[21] such that ethanol-based 11.6% chlorhexidine has been approved by the American Dental Association and the Food and Drug Administration.[18] The effect of ethanol-based chlorhexidine mouthrinse, was more than ethanol-free Epimax mouthrinse. The higher efficacy of ethanol-based Hexidine mouthwash can be associated with the objectives of adding alcohol to this solution. These objectives include prevention of dissolving other components of the mouthrinses, adding antiseptic property to the mouthrinses and significant role of alcohol in stabilizing the specific components of mouthrinses.[18]

In addition, the mean GI reduced significantly in both ethanol-based Hexidine and ethanol-free Epimax groups after the use of mouthrinses, which is compatible with the results of previous studies.[1],[2],[16],[21] However, the reduction of GI in Hexidine group was a little higher. The higher efficacy of ethanol-based Hexidine can be attributed to the objectives resulting from adding alcohol to these mouthrinses, as mentioned above.

Many studies have confirmed the effect of chlorhexidine mouthrinses on increasing the dental stains.[19],[21] According to [Table 2], the mean Lobene index in Hexidine group (ethanol-based 0.12% chlorhexidine) was similar to that of ethanol-based 0.12% chlorhexidine reported by Moghareh Abed et al. in terms of both intensity and extent.[22] The mean intensity of Lobene index after using the mouthrinses in ethanol-free Epimax group was significantly 1.5 times higher than that of ethanol-based Hexidine group. On the other hand, the stain intensity was lower in ethanol-based Hexidine group. This may be due to the pervention of alcohol on the formation of stain on the surface of the teeth. As a dication, chlorhexidine is bonded to the dye anions, thereby making them to sediment. The alcohol in mouthrinses competes with the dye anions to bond to dication (chlorhexidine) and makes the dye anions have less sediment.[23]

The patients in ethanol-free Epimax group did not show any side effects. Whereas seven patients in ethanol-based Hexidine group show side effects such as allergy and burning mouth. The side effects of ethanol-based chlorhexidine mouthwash have also been shown in previous studies[22] and ethanol-free mouthrinses have been reported as antiplaque and anti-inflammation mouthrinses with minimum side effects.[16]

According to the results of the current research, both ethanol-based Hexidine and ethanol-free Epimax mouthrinses reduced gingival and plaque indices. Ethanol-free Epimax mouthwash can be prescribed as an antiplaque and anti-inflammation mouthrinse with no side effects for the patients with contraindication due to alcohol consumption; however, the patients should be informed of discoloration of their anterior teeth in advance. Ethanol-based Hexidine mouthrinse, which has higher efficacy, can be prescribed for the patients, but its side effects should be taken into consideration. Therefore, decisions about prescription of mouthrinses based on the alcohol content should be made by considering the advantages and disadvantages of each of them, the patient’s conditions, and clinical judgments.

Similar studies are recommended to evaluate the microbiologic effects of these mouthrinses. Further studies are also suggested to compare the efficacy and side effects of different mouthrinses with and without alcohol, manufactured by different factories, with a placebo.


  Conclusion Top


Both mouthrinses significantly reduced PI; however, Hexidine mouthwash was reported to have higher efficacy. Also, the mean GI in both groups was significantly reduced, with more reduction ability on the part of Hexidine. Moreover, Hexidine mouthwash created less stain than Epimax mouthwash. Finally, the frequency of the side effects of both mouthrinses was very small. However, Epimax mouthrinse was shown to have fewer side effects.

Acknowledgments

The authors would like to extend their gratitude to the Vice Chancellery for Research of the School of Dentistry, the Isfahan University of Medical Sciences, for providing the financial support.

Financial support and sponsorship

This project was financially supported by Vice Chancellery for Research and Technology, Isfahan University of Medical Sciences, Isfahan, Iran (Grant #930393).

Conflicts of interest

Authors have no conflicts of interest.

 
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