Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 


 
 Table of Contents  
ORIGINAL ARTICLE
Year : 2014  |  Volume : 12  |  Issue : 3  |  Page : 157-162

Efficacy of mouth rinses on dental plaque and gingivitis: A randomized, double-blind, placebo-controlled clinical trial


1 Department of Public Health Dentistry, Meghna Institute of Dental Sciences, Nizamabad, Telangana, India
2 Department of Public Health Dentistry, KVG Dental College and Hospital, Sullia, Karnataka, India

Date of Web Publication15-Nov-2014

Correspondence Address:
Arun Shyam
Department of Public Health Dentistry, Meghna Institute of Dental Sciences, Nizamabad 503 003, Telangana
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2319-5932.144785

Rights and Permissions
  Abstract 

Introduction: Over the years chlorhexidine (CHX), triclosan and sodium fluoride (NaF) mouth rinses are used alone or combined in the prevention of dental diseases. However, at present little is known about the combined effects of NaF + triclosan and CHX + NaF + triclosan mouth rinses on reducing dental plaque and gingivitis. Aim: The aim was to determine the efficacy of mouth rinses used as adjuncts to regular oral hygiene measures on reducing dental plaque and gingivitis. Materials and Methods: A randomized, placebo-controlled, double-blind, parallel-group study was conducted for 6-month, among 12-15 years old school children in Nellore, India. Eligible subjects (n = 210) with consent were randomly allocated to four groups and were provided with a mouth rinse (Group A = 0.2% CHX; Group B = 0.05% sodium fluoride + 0.03% triclosan; Group C = 0.2% CHX + 0.05% sodium fluoride + 0.03% triclosan; Group D = Placebo). All subjects used 10 ml of mouth rinse, once daily for 60 s. The clinical parameters evaluated were plaque index (PlI) and gingival Index (GI). Statistical significance within and between four groups was tested using one-way analysis of variance (ANOVA), repeated measures ANOVA with post-hoc and paired t-test. Results: At the end of clinical trial, the three test groups showed statistically significant (P < 0.001) reduction in PlI and GI scores compared with placebo group. Conclusion: The active agents demonstrated highly potent antiplaque and antigingivitis properties when compared to placebo.

Keywords: Chlorhexidine, dental plaque, gingivitis, sodium fluoride, triclosan


How to cite this article:
Shyam A, Fareed N. Efficacy of mouth rinses on dental plaque and gingivitis: A randomized, double-blind, placebo-controlled clinical trial. J Indian Assoc Public Health Dent 2014;12:157-62

How to cite this URL:
Shyam A, Fareed N. Efficacy of mouth rinses on dental plaque and gingivitis: A randomized, double-blind, placebo-controlled clinical trial. J Indian Assoc Public Health Dent [serial online] 2014 [cited 2019 Sep 23];12:157-62. Available from: http://www.jiaphd.org/text.asp?2014/12/3/157/144785


  Introduction Top


Early human dental plaque formation is initiated by the deposition of a thin biofilm mainly derived from salivary glycoproteins onto the tooth surface. When one or two layers of bacteria are present on the tooth surface in a healthy individual, the subject's immune system can cope with these microorganisms, and the subject can thus present a healthy gingiva. Therefore, disturbing plaque formation is of major importance. One approach in dental plaque control thus be to combine the use of chemical agents with the mechanical cleaning. [1] The rationale for the use of antiplaque agents as adjuncts to mechanical methods is based on two premises. First, plaque is the major etiological factor in gingivitis and studies of tooth cleaning suggest that mechanical cleaning methods are inadequate. [2]

The antiplaque agents (action through plaque effects) can be subdivided for possible modes of action against plaque: Prevent bacterial attachment (anti adhesive); inhibit bacterial division (antimicrobial agents); remove plaque ("chemical tooth brush"); and alter plaque ecology. Until date, antimicrobial agents have had the most success, with little or no achievements in the other areas. [3]

A number of antimicrobial agents have been studied in respect to the control of supra gingival plaque and they can be divided into bisguanide antiseptics, quaternary ammonium antiseptics, phenolic antiseptics, other antiseptics, oxygenating agents, metal ions and natural products. [4] The cationic bis-biguanide chlorhexidine (CHX) is the gold standard antimicrobial agent. [5] Several studies have proved the efficacy of CHX digluconate mouth rinse in reducing gingivitis and dental plaque accumulation. [6],[7] Triclosan, a broad-spectrum, lipid-soluble agent, is widely used in toothpastes and mouth rinses to reduce plaque formation and to improve gingival health. [7],[8],[9] It, has a double barrel effect both antibacterial and antiinflammatory. [9]

The efficacy of 0.05% sodium fluoride mouth rinse in caries control is well-established. [10] However, there is little evidence to suggest its effectiveness on dental plaque and gingivitis. One potentially useful combination of CHX in any oral hygiene product would be fluoride. [11] The results of a 2-year clinical trial involving the use of combined CHX (0.05%) and sodium fluoride (0.044%) mouth rinse showed a significant reduction in gingival bleeding as well as the least DMFS increment. [12] In studies conducted for 8 weeks and 6 weeks, combined CHX and sodium fluoride mouth rinse demonstrated a significant inhibitory effect on plaque and gingival bleeding. [11],[13] In a cross-over study, fluoride/triclosan/oil rinse failed to demonstrate any clinically significant advantage over the control rinse at 24 or 96 h in inhibiting dental plaque. [14]

Over the years CHX, triclosan and sodium fluoride (NaF) mouth rinses are used alone or combined in the prevention of dental diseases. However, at present, little is known about the combined effects of NaF + triclosan formulation and addition of CHX to NaF + triclosan mouth rinse on dental plaque and gingivitis. Therefore, this study was designed and carried out to assess the efficacy of CHX, sodium fluoride plus triclosan or CHX in combination with sodium fluoride and triclosan as mouth rinses for dental plaque accumulation and gingivitis using a protocol that satisfied the American dental association council on dental therapeutics (CDT-1986) guidelines for clinical trials.


  Materials and Methods Top


Ethical aspects

An institutional review board and Ethical Committee gave approval for the study (IEC/1091/04.01.2010). This study was performed in accordance with the guidelines of Good Clinical Practice and Declaration of Helsinki as revised in 2000. The investigator provided detailed information about the study procedure, the benefits and the possible side-effects associated with the trial to the parents, and written consent was obtained.

Study design

A randomized, placebo-controlled, double-blinded, parallel-group study was conducted for 6-month among 12-15 years old school children in Nellore, India. The inclusion criteria were: (1) Children with fully erupted permanent dentition; (2) baseline plaque index (PlI) and gingival index (GI) scores of 2-3 (3) apparently healthy and (4) an ability to use a mouth rinse. The exclusion criteria were: (1) Subjects undergoing orthodontic treatment (2) subjects with an intraoral prosthesis (3) medically compromised subjects.

Sample size

A pilot study was conducted on 50 subjects before the main study to standardize the methods. The sample size with the power of 80% and α error of 0.05% was estimated based on the pilot study data. Additional 5% of the subjects were added to the estimated sample of 200 to compensate for sampling loss, if any. Thus, the final sample accounted for 210 and the study subjects were selected from among 450 school children upon satisfying the inclusion and exclusion criteria.

Randomization and blinding

Manufacturing company M/S Group Pharmaceuticals was requested to provide the required quantity of mouth rinses in a precoded consignment of identical bottles that are color coded. Pharmaceutical company considered the request and provided samples free of cost. The children were drawn from three randomly selected schools of Nellore city. The eligible children from each school were randomly allocated into four groups (A, B, C and D) using computer-generated random numbers. The investigator and the participants were unaware of the group allocation and the composition of the mouth rinse received by the respective groups. Decoding was done by the manufacturing company after the analysis of results.

Calibration

Data recording was done by a recorder who had been trained and calibrated prior to the main study. To evaluate the intra-examiner reliability, duplicate examinations were conducted. The related kappa values were 0.84, 0.92 and 0.94 for clinical examinations at various phases of the study.

Study outcomes

Clinical examinations were performed over a period of 5 days each at baseline, 3-month and 6-month. At the baseline examination, personal information of the subjects was recorded in a specially prepared pro-forma. The children were examined on a chair by the investigator under good illumination using a mouth mirror and an explorer. At each intraoral examination, presence of plaque and gingivitis was determined using the criteria suggested by Loe. [15] PlI and GI scores were recorded on all surfaces (mesial, distal, buccal, palatal/lingual) of all the teeth. The scores from the four areas of the tooth were added and divided by four to give the PlI/GI for the tooth. PlI and GI for the individual is obtained by adding the indices for the teeth and dividing by the number of teeth examined. Reduction in PlI score was considered as the primary outcome and difference in GI scores between four groups was the secondary outcome.

Procedure

The investigator demonstrated and trained the subjects regarding a proper method of mouth rinsing. Ten milliliters of mouth rinse from the respective bottles was measured using a graduated plastic jar and dispensed to the subjects. They were made to rinse thoroughly once daily for 60 s and spit out the solution. After this procedure, the children were instructed not to eat or drink anything for about 30 min. The above procedure was repeated on each school day during morning hours for a period of 6-month, starting October 2010. The subjects were instructed to report any adverse events such as sickness, change in taste perception, soreness of the tongue, edema, redness, sensitivity, burning sensation of the oral mucosa and visible staining during the course of the study, to the class teacher or investigator. Such a finding was duly recorded in the pro-forma.

Statistical analysis

Statistical analysis was performed on an intention-to-treat basis, with missing data being imputed as the same as data from the inclusion period. The alpha (α) level of significance was taken as 0.05, and the confidence intervals were set at 95%. Statistical significance within and between four groups was tested using one-way analysis of variance (ANOVA), repeated measures ANOVA with post-hoc and paired t-test, using the program SPSS for Windows (version 17.0; SPSS Inc., Chicago, IL, USA).


  Results Top


A consort flow chart of study design and number of subjects at each phase of the study has been described [Figure 1]. [Table 1] shows basic demographic characteristics of the study subjects. The overall dropout rate was remarkably small (2.85%) and it has had negligible influence on the results. During the entire study period, differences in dietary habits or oral hygiene practices were slight and not significant among the four groups.
Figure 1: Consort flow chart

Click here to view
Table 1: Participant's characteristics


Click here to view


[Table 2] and [Table 3] shows the mean PlI and GI scores of each group at 3 times points. It indicates that within and between group difference at baseline is not significant for PlI and GI, thus at baseline all four groups are similar. At 3-month and 6-month time interval, PlI and GI scores were highly significant in all the groups, revealing existing difference between the groups. Mean PlI scores from baseline to 6-month was calculated among four groups. It was found that 67% of C group subjects had a significant reduction in mean PlI, followed by A (56%) and B groups (45%). However, D group subjects showed a slight increase in mean PlI score from baseline (2.51 ± 0.32) to 6-month (2.68 ± 0.34).
Table 2: Mean values of PlI among all treatment groups


Click here to view
Table 3: Mean values of GI among all treatment groups


Click here to view


Repeated measures ANOVA was carried out for both PlI and GI scores. The Greenhouse geisser was highly significant for both PlI and GI scores and thereby showed the difference in scores over a period of time. A multiple comparisons was done using the bonferroni post-hoc test to compare PlI and GI scores between the groups and the results demonstrate that the difference in mean scores is significant between the groups. Group C has highly significant difference in mean scores as compared to other groups with the P < 0.001 [Table 4] and [Table 5].
Table 4: Comparison of PlI scores between the groups


Click here to view
Table 5: Comparison of GI scores between the groups


Click here to view


Comparison of baseline to 6-month mean GI scores revealed that 64% of C group subjects had a significant reduction in mean GI, followed by A (53%) and B groups (45%). A slight increase in mean GI score was observed among D group subjects from baseline (2.49 ± 0.31) to 6-month (2.65 ± 0.35).


  Discussion Top


The present trial determines the efficacy of three mouth rinses on reducing dental plaque and gingivitis. In this study, school children aged 12-15 years were included since 12-year is the global monitoring age for dental caries and 15-year age for the assessment of periodontal disease indicators in adolescents. [16] Mouth rinses with active agents, alone or combined, in the treatment of dental plaque and gingivitis, were tested among school children in previous studies. [12],[17],[18] This study was intended to find the cumulative effect of mouth rinsing and hence a standard protocol of clinical examination was done within 30 min after rinsing. Further, no precautions were taken to change subjects normal oral hygiene methods.

After completion of statistical analysis, the pharmaceutical company revealed the content of the mouth rinses to be as follows: Group A = 0.2% CHX; Group B = 0.05% sodium fluoride + 0.03% triclosan; Group C = 0.2% CHX + 0.05% sodium fluoride + 0.03% triclosan; Group D = Placebo.

This study was conducted in accordance with the American dental association CDT-1986 guidelines for clinical trials. These guidelines require that clinical trials: Be cross-over or parallel-designed, study subjects should represent typical product users, active agent should be compared with a placebo or active control, dental plaque and gingivitis scoring be conducted at baseline, 6-month and an intermediate interval. [19]

The results of this study conducted over a period of 3-month demonstrated a significant reduction in the mean PlI and GI scores compared with baseline in A, B and C groups (P < 0.001). It was found that there was a slight reduction in mean PlI and GI among D group subjects who used a placebo rinse. This can be explained on the basis of the Hawthorne effect or Participation effect, which can be an important confounding variable in clinical therapeutic trials. [19] At 6-month again there were statistically significant differences in mean PlI and GI scores between the A, B and C groups compared with baseline. However, a slight increase in mean PlI and GI scores were observed among the D group, indicating that the Hawthorne effect was possibly nullified. The other potential bias if any was eliminated through randomization and blinding.

Use of 0.05% NaF + 0.03% triclosan mouth rinse produced a significant reduction in mean PlI and GI scores (P < 0.001). In fact, 0.05% NaF + 0.03% Triclosan mouth rinse provided better mean reduction compared with placebo. However, the reduction achieved was less than that of using plain 0.2% CHX and 0.2% CHX + 0.05% NaF + 0.03% Triclosan mouth rinse. This lesser reduction in PlI and GI scores when compared to the other two active agents could be attributed to the facts that NaF does not exhibit any significant substantivity, so categorized as first-generation antimicrobial agent [1] and effectiveness of triclosan is dose dependent. [20]

Significant reduction in mean PlI and GI scores on use of 0.05% NaF + 0.03% Triclosan mouth rinse could be due to the use of a solution which possesses antibacterial, antiplaque and antiinflammatory effects. Triclosan has both antibacterial and antiinflammatory effects. This unique feature is not provided so far by any other antibacterial and antiplaque agents. [9] The safety, antiplaque and antigingivitis properties of triclosan have been reported in the literature. [6],[7],[8],[21] The results obtained in this study on use of fluoride/triclosan mouth rinse are in contrary to the findings of a cross-over study in which fluoride/triclosan/oil rinse failed to demonstrate any clinically significant advantage over the control rinse at 24 or 96 h in inhibiting dental plaque. [14]

Over the decades, a number of clinical trials have clearly documented the beneficial effects of CHX in the control of plaque and gingivitis. [5],[6] Lang et al. [18] tested the effects of supervised rinsing with CHX in 158 school children, aged 10-12 years. After 6-month, it was concluded that gingivitis can be controlled successfully by regularly using 0.1% or 0.2% CHX mouth rinses. The results of this study on the use of 0.2% CHX are in agreement with the study of Lang et al. [18] In this study, 0.2% CHX was chosen as one of the active agent as it is considered the gold standard against which other antiplaque agents are measured. [5] The reduction in PlI and GI scores on using CHX could be attributed to the prolonged antibacterial activity and dual antibacterial effect of CHX at the tooth surface, as a result of its di-cationic nature as described by Jones. [5]

Results of this study showed that mouth rinse with combined agents of 0.2% CHX + 0.05% NaF + 0.03% Triclosan is superior in reducing mean PlI and GI scores. This finding was in agreement with those of other studies, which tested combined active agents of CHX and NaF on caries/dental plaque/gingivitis. [11],[12],[13],[17] In this study, one possible reason for the superior effect of CHX + NaF + Triclosan in reducing plaque and gingivitis, when compared to other two mouth rinses could be attributed to the synergetic effect when the three agents are used together. In a clinical trial Luoma et al. [12] suggested that there would be a possible synergistic effect when the two agents (CHX, NaF) are used together.

Local side-effects such as staining of teeth and disturbance in taste were reported between 60% of subjects who rinsed with 0.2% CHX + 0.05% NaF + 0.03% Triclosan solution and plain 0.2% CHX. The role of CHX in causing these side-effects are reported in the literature. [1],[22] However, the role of triclosan and sodium fluoride in causing these effects needs to be studied further. The external validity of this study can be considered to be good may be because the study design is randomized controlled trial, and it is done under natural conditions. This study has not taken into consideration the financial implications upon the subjects in case the procedure has to be implemented at the community level daily. We do not have any conflict of interest.


  Conclusion Top


Within the limitations of the present trial, it can be concluded that the active agents used in this study demonstrated highly potent antiplaque and antigingivitis properties when compared to placebo. The adjunctive use of these active agents in daily oral hygiene practices is warranted.


  Acknowledgments Top


We gratefully acknowledge the support and assistance of the Group Pharmaceuticals, Bangalore, India. We thank Mr. John Michael (Bio-statistician) for his help in statistical analysis.

 
  References Top

1.
Brecx M. Strategies and agents in supragingival chemical plaque control. Periodontol 2000 1997;15:100-8.  Back to cited text no. 1
    
2.
Moran JM. Chemical plaque control - Prevention for the masses. Periodontol 2000 1997;15:109-17.  Back to cited text no. 2
    
3.
Addy M, Moran JM. Evaluation of oral hygiene products: Science is true; don't be misled by the facts. Periodontol 2000 1997;15:40-51.  Back to cited text no. 3
    
4.
Eley BM. Antibacterial agents in the control of supragingival plaque - A review. Br Dent J 1999;186:286-96.  Back to cited text no. 4
[PUBMED]    
5.
Jones CG. Chlorhexidine: Is it still the gold standard? Periodontol 2000 1997;15:55-62.  Back to cited text no. 5
    
6.
Santos A. Evidence-based control of plaque and gingivitis. J Clin Periodontol 2003;30 Suppl 5:13-6.  Back to cited text no. 6
[PUBMED]    
7.
Paraskevas S. Randomized controlled clinical trials on agents used for chemical plaque control. Int J Dent Hyg 2005;3:162-78.  Back to cited text no. 7
[PUBMED]    
8.
Kjaerheim V, Waaler SM. Experiments with triclosan-containing mouthrinses: Dose response - and an attempt to locate the receptor site(s) of triclosan in the mouth. J Adv Dent Res 1994;8:302-6.  Back to cited text no. 8
    
9.
Gaffar A, Afflitto J, Nabi N. Chemical agents for the control of plaque and plaque microflora: An overview. Eur J Oral Sci 1997;105:502-7.  Back to cited text no. 9
    
10.
Stephen KW. Fluoride toothpastes, rinses, and tablets. Adv Dent Res 1994;8:185-9.  Back to cited text no. 10
[PUBMED]    
11.
Jenkins S, Addy M, Newcombe R. Evaluation of a mouthrinse containing chlorhexidine and fluoride as an adjunct to oral hygiene. J Clin Periodontol 1993;20:20-5.  Back to cited text no. 11
    
12.
Luoma H, Murtomaa H, Nuuja T, Nyman A, Nummikoski P, Ainamo J, et al. A simultaneous reduction of caries and gingivitis in a group of schoolchildren receiving chlorhexidine-fluoride applications. Results after 2 years. Caries Res 1978;12:290-8.  Back to cited text no. 12
[PUBMED]    
13.
Joyston-Bechal S, Hernaman N. The effect of a mouthrinse containing chlorhexidine and fluoride on plaque and gingival bleeding. J Clin Periodontol 1993;20:49-53.  Back to cited text no. 13
    
14.
Moran J, Addy M, Newcombe RG, Marlow I. A study to assess the plaque inhibitory activity of a new triclosan mouthrinse formulation. J Clin Periodontol 2000;27:806-9.  Back to cited text no. 14
    
15.
Loe H. The gingival index, the plaque index and the retention index systems. J Periodontol 1967;38:610-6.  Back to cited text no. 15
    
16.
WHO. Oral Health Surveys, Basic Methods. 4 th ed. India: AITBS publishers; 1997. p. 7.  Back to cited text no. 16
    
17.
Jayaprakash K, Veeresha KL, Hiremath SS. 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;25:126-9.  Back to cited text no. 17
[PUBMED]  Medknow Journal  
18.
Lang NP, Hotz P, Graf H, Geering AH, Saxer UP, Sturzenberger OP, et al. Effects of supervised chlorhexidine mouthrinses in children. A longitudinal clinical trial. J Periodontal Res 1982;17:101-11.  Back to cited text no. 18
[PUBMED]    
19.
Barnett ML. The role of therapeutic antimicrobial mouthrinses in clinical practice: Control of supragingival plaque and gingivitis. J Am Dent Assoc 2003;134:699-704.  Back to cited text no. 19
[PUBMED]    
20.
Jenkins S, Addy M, Newcombe RJ. A dose-response study of triclosan mouthrinses on plaque regrowth. J Clin Periodontol 1993;20:609-12.  Back to cited text no. 20
    
21.
Gaffar A, Scherl D, Afflitto J, Coleman EJ. The effect of triclosan on mediators of gingival inflammation. J Clin Periodontol 1995;22:480-4.  Back to cited text no. 21
    
22.
Lang NP, Brecx MC. Chlorhexidine digluconate-An agent for chemical plaque control and prevention of gingival inflammation. J Periodontal Res 1986;21 Suppl s16:74-89.  Back to cited text no. 22
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

Top
 
 
  Search
 
Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
Access Statistics
Email Alert *
Add to My List *
* Registration required (free)

 
  In this article
Abstract
Introduction
Materials and Me...
Results
Discussion
Conclusion
Acknowledgments
References
Article Figures
Article Tables

 Article Access Statistics
    Viewed2048    
    Printed30    
    Emailed0    
    PDF Downloaded332    
    Comments [Add]    

Recommend this journal


[TAG2]
[TAG3]
[TAG4]