Year : 2007 | Volume
: 25 | Issue : 3 | Page : 126--129
A comparative study of two mouthrinses on plaque and gingivitis in school children in the age group of 13-16 years in Bangalore city
K Jayaprakash1, KL Veeresha2, SS Hiremath3,
1 Department of Preventive and Community Dentistry, Rama Dental College and Hospital, Kanpur - 208 024, India
2 Department of Preventive and Community Dentistry, MM Dental College and Research Centre, Ambala - 133203, India
3 Department of Preventive and Community Dentistry, Governmental Dental College, Bangalore - 560002, India
Department of Preventive and Community Dentistry, Rama Dental College and Hospital, Kanpur - 208024
Research and clinical evidence indicate that most forms of plaque associated periodontal disease start as inflammatory lesions of the gingiva which if left untreated, may progress and eventually involve and compromise the entire periodontal attachment apparatus of the affected teeth. A study was conducted to assess the effect of a mouthrinse containing chlorhexidine and sodium fluoride on plaque accumulation and gingivitis in comparison with a chlorhexidine mouthrinse alone in a group of school children aged 13-16 years in Bangalore city. This combination alongwith the well established effect of fluoride in the prevention of caries presents an important contribution to dental public health. The results suggest that the chlorhexidine-sodium fluoride mouthrinse potentially possesses a significant effect on inhibition of plaque accumulation and gingivitis. This combination along with the well-established effect of fluoride in the prevention of caries, presents an important contribution to dental public health.
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Jayaprakash K, Veeresha K L, Hiremath S S. A comparative study of two mouthrinses on plaque and gingivitis in school children in the age group of 13-16 years in Bangalore city.J Indian Soc Pedod Prev Dent 2007;25:126-129
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Jayaprakash K, Veeresha K L, Hiremath S S. A comparative study of two mouthrinses on plaque and gingivitis in school children in the age group of 13-16 years in Bangalore city. J Indian Soc Pedod Prev Dent [serial online] 2007 [cited 2020 Feb 17 ];25:126-129
Available from: http://www.jisppd.com/text.asp?2007/25/3/126/36562
Periodontal diseases frequently begin in childhood and often have lifelong sequelae; hence, primary preventive care must begin early in life before the onset of this problem. The maintenance of proper oral hygiene over prolonged periods of time by mechanical tooth-cleaning methods is, however, laborious and difficult. Consequently, efforts have been made to utilize chemical agents in conjunction with or even instead of mechanical plaque control and have been tested by incorporating them into mouthwashes. Over the years, a number of enzyme preparations, antiseptics and surface active agents have been used as supplements to regular tooth cleaning. , Chlorhexidine digluconate is the most effective antimicrobial used in the prevention and resolution of gingivitis, ,, although it causes the staining of the teeth. 
Fluoride has been primarily utilized as an anticaries agent. The use of fluoride mouthrinses are probably one of the most commonly used methods for caries prevention. The antigingivitis potential of sodium fluoride in combination with chlorhexidine has rarely been evaluated. , At present, no chlorhexidine-sodium fluoride products are commercially available and there is limited literature available on the synergetic effect of chlorhexidine and sodium fluoride on plaque accumulation and gingivitis in the form of a mouthrinse among teenagers who are particularly prone to gingivitis.  Hence, a study was planned to assess the effect of a mouthrinse containing chlorhexidine and sodium fluoride on plaque accumulation and gingivitis in comparison with a mouthrinse containing chlorhexidine alone in a group of school children aged 13-16 years in Bangalore City.
The aim of the study was to assess and compare the clinical effect of a mouthrinse containing chlorhexidine (0.05%) and sodium fluoride (0.05%) on plaque accumulation and gingivitis.
Materials and Methods
A double-blind study was designed and the study design was approved by the Ethical committee of the Government Dental College, Bangalore. Since this study was a clinical trial spread over a period of 6 months, maintaining the interest of proximity and feasibility, Sri Laksmi Narasimha High School, Fort road, Bangalore, was selected. The permission of the school authorities was obtained for the continuous cooperation and support during the study period.
Since the study age group was 13-16 years, students from VIII, IX, and X standard were included in the study. Informed written consent was obtained from the parents/guardians after explaining the methodology of the clinical trial and the possible adverse effects.
Inclusion criteria involved written informed consent from parents, good general health of children, a minimum of 12 gradable teeth, agreement to delay any elective dental treatment, including oral prophylaxis during the course of the study, and the agreement to comply with the study visits and procedures. Exclusion criteria involved antibiotic therapy, history of early-onset periodontitis, acute necrotizing ulcerative gingivitis, gross oral pathology, treatment for cancer or seizure disorders and conditions that interfered with the examination procedures. Before the examination was started, personal information regarding the subject were recorded in specially prepared proforma. The subjects were examined on a straight chair under natural light using the diagnostic instruments. The plaque index (Silness and Loe)  and the gingival index (Loe and Silness)  were used to assess the plaque accumulation and gingivitis. The teeth were dried and examined under natural light using a mouth mirror, probe and explorer. Wherever the plaque was not visible, the explorer was passed across the tooth surface in the cervical third. The probe was made to run along the soft tissue wall near the gingival sulcus to evaluate the bleeding for the gingival index. The examinations were conducted at baseline, after 1 month, 3 months and 6 months. The students were randomly numbered 1-150 and the mouthwash samples were numbered randomly 1-150 by the mouthrinse manufacturer. The coding was done by the manufacturer and the three different solutions were known only to him. It was later deciphered to the investigator at the end of the study. The students who were assigned with particular numbers were provided with the mouthwash with the same number. The investigator himself supervised the mouth rinsing performed by the students daily. Ten milliliters of mouthwash samples from their respective bottles were measured and administered to the students and they were instructed not to eat or drink anything for an hour after using the mouthwash. The concentrations of chlorhexidine and sodium fluoride were 0.05%, which was used in most of the previous studies.  A plastic measuring jar was used to measure the quantity of mouthrinse to be administered. The students were also instructed to report any spells of sickness, change in taste perception or visible staining of teeth during the course of the study. Once the study was completed, the manufacturer in the factory did the decoding of the three mouthwash groups. The variables were all nonparametric and warranted Kruskal Wallis test, Mann-Whitney test, Median test and Wilcoxson sign rank test. A P value less than 0.05 was considered to be statistically significant.
Results and Discussion
The combination of fluoride and chlorhexidine has been known to be very effective against both dental caries and gingivitis. , The teenage population was chosen as these subjects are known to often practice inadequate oral hygiene measures, experience gingivitis, but rarely demonstrate symptoms of periodontal diseases. 
The design was intended to represent the conditions of the general public, particularly teenage school children as far as possible; therefore, no oral prophylaxis and oral hygiene instructions were given. The three groups were randomly divided as follows:
A = placebo; B = chlorhexidine; C = chlorhexidine + sodium fluoride.
Plaque: A general improvement in plaque scores was noticed among all the participants at the time of examination at 1 month. This can be attributed mainly to Hawthorne effect.  During the examination performed at 3 months, there was no significant difference between the groups A, B and C, but the mean plaque scores showed an increase in all the groups in comparison to the scores at 1 month, which might be due to the weaning of the interest of the study population in maintaining the oral hygiene. There was a statistically significant difference at 6 months in the mean plaque score in the A and C and B and C groups [Table 1]. Similarly, when the groups were individually compared, the result showed that group C was having the least mean plaque score ( P = 0.04) followed by group B [Figure 1].
Undoubtedly, this re-establishes the fact that the combination of chlorhexidine and sodium fluoride is superior to the chlorhexidine mouthrinse with regard to the inhibition of the plaque accumulation. This result is similar to the result obtained by Jenkins  and Joysten.  Furthermore, it supports the previous work, proving that chlorhexidine alone does not completely eliminate plaque accumulation. 
Gingivitis: The gingival scores showed a trend similar to that of the plaque scores in relation to examinations done at 1 month and 3 months. However, at the end of 6 months, a decrease in the mean gingival scores was observed only in group C, whereas there was an increase in group A and B. There was a significant difference between the group A and C ( P = 0.016) and no significant difference between A and B group [Table 2], [Figure 2]. This does not necessarily rule out the therapeutic effect of chlorhexidine but clearly demonstrates that when individual agents are used in clinical trials on gingivitis, different results may be obtained. In the present study, the reasons are not immediately clear as to why considerable difference was not obtained between the group A and group B (placebo and chlorhexidine, respectively).
The possible reasons for the effect of placebo in gingivitis reduction are debatable. However, it appears that in a clinical setting, a suggestion is made to the patient that a prescribed product is an effective treatment that leads to considerable improvement, irrespective of the therapeutic potential of the formulation. Many other studies have had placebos to either provide a competitive result with the therapeutic agent or to exert a better effect than the therapeutic agent being tested as in the case of drug trials for other conditions such as recurrent oral aphthous ulceration. , However, in a study such as the present one, this would almost certainly require that the nature of the investigation be hidden from the participants. This would be not only difficult or impossible to achieve but, with today's guidelines for clinical trials, has significant ethical implications.
All the above findings suggested that chlorhexidine-sodium fluoride mouthrinse was more effective in reducing plaque accumulation and gingivitis when compared to the mouthrinse that contained only chlorhexidine or placebo.
Summary and Conclusion
This study showed that a combination of mechanical cleaning and supervised mouthrinse program is more beneficial for plaque control than the use of the mechanical method alone. Furthermore, it also demonstrates that in a short duration, mouthrinse with the chlorhexidine-sodium fluoride combination possesses a better action on plaque accumulation and gingivitis in comparison to chlorhexidine alone, and further investigations are needed to confirm the findings of this study. To conclude the results of the present study, it suggests that the chlorhexidine-sodium fluoride mouthrinse potentially possesses a significant effect on reducing plaque accumulation and gingivitis. This combination along with the well-established effect of fluoride in the prevention of caries presents an important contribution to the dental public health.
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