Chlorhexidine spray as an adjunct in the control of dental biofilm in children with special needs

C H L O R H E X I D I N E S P R A Y I N S P E C I A L N E E D S

286 Spec Care Dent is t 34(6 ) 2014 © 2014 Special Care Dentistry Association and Wiley Periodicals, Inc. DOI: 10.1111/scd.12069

A R T I C L E

The aim of this study was to evaluate the clinical effectiveness of .12% chlorhexidine applied via spray and the acceptance. A total of 26 individuals with mental health issues, aged 7–14, were included into two groups: placebo (control, n = 13) and chlorhexidine (experimental, n = 13). Both groups received two daily applications of spray during 2 months. The periodontal condi-tions were evaluated by the simplified oral hygiene index (OHI-S) and gingival index (GI). The evaluation of acceptance of the application method (spray) was assessed by questionnaire. Data were analyzed with nonparametric tests, with a significance level of 5%. Regarding the OHI-S index, only the experimental group showed significant change during the evaluations (p < 0.001). Regarding the GI, both groups showed significant changes during the evaluations. The method of application was well accepted by patients and caregivers, and .12% chlorhexidine solution applied via spray significantly reduced the rates of dental and gingival biofilm.

A B S T R A C T Chlorhexidine spray as an adjunct in the control of dental biofilm in children with special needsGilberg Resende Viana, DDS;1 Ana Paula Teiltelbaum, PhD;1 Fábio André dos Santos, PhD;1 Aida Sabbagh-Haddad, PhD;2 Renata Oliveira Guaré, PhD3*

1Department of Dentistry, School of Dentistry, Ponta Grossa State University, Ponta Grossa,

Paraná, Brazil; 2Persons with Disabilities Division, NAPODONTO (Núcleo de Aperfeiçoamento

Profissional em Odontologia), São Paulo, São Paulo, Brazil; 3Persons with Disabilities Division,

Universidade Cruzeiro do Sul, São Paulo, São Paulo, Brazil.

*Corresponding author e-mail: [email protected]

Spec Care Dentist 34(6): 286-290, 2014

Despite the great commitment of caregivers, oral hygiene in patients with special needs has proved inadequate and ineffective in many cases using conven-tional methods, bringing with it serious consequences for oral health and making the dental treatment of these patients increasingly difficult and expensive. Thus, the complementation of oral hygiene is very important, and the use of chemical agents to control biofilm, applied through a simple and practical method, is a necessity for these individuals.3-6

Chlorhexidine has been shown to be the preferred antiseptic, as an adjunct to oral hygiene in patients with special needs, when the aim is the chemical con-trol of dental biofilm, and application through spray has received attention due to its good clinical results.7-13

In view of reports in the literature, and the need to control biofilm, we con-sidered that it was timely to carry out a clinical investigation of the effects of chlorhexidine applied via spray as an adjunct to oral hygiene in patients with mental health issues, and to evaluate the acceptance of patients and caregivers regarding the method of application.

Mate r i a l s and me thodsThis clinical investigation was conducted according to the principles expressed in the Declaration of Helsinki. This project was reviewed by the Human Research Ethics Committee and approved by Cruzeiro do Sul University Institutional Review Board. The inclusion criteria were: diagnosis of mental health issues,

I n t r oduc t i onThe social inclusion of patients with special needs is a worldwide necessity nowadays. It is estimated that 10% of the world population consists of individuals with special needs and that 50% of them have mental health issues. This population is characterized by intellectual functioning that is significantly below average, accompanied by significant limitations in adaptive functioning in at least two of the following areas: communication, daily living activities, personal care, social/interpersonal skills, com-munity living, self-sufficiency, academic skills, work, leisure, and health and safety.1 Approximately 45.6 million Brazilians (23.9%) have some type of disability and 2.6 million (1.36%) have mental health issues.2

KEY WORDS: plaque control, gingivitis, oral hygiene, special care

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regardless of level, aged 7 to 14, and those responsible should sign a written informed consent form. The exclusion criteria were: mental health issues associ-ated with syndromes, extensive caries, dentoalveolar and/or periodontal abscess, patients treated with antibiotics or those with systemic diseases such as diabetes, cancer, heart disease, and chronic kidney disease. Thirty individuals were selected and they were divided into two groups of 15 volunteers each. The experimental group used 0.12% chlorhexidine applied via spray and the control group used a spray containing a placebo.

Both groups received two daily appli-cations of spray: one application during the period in which they were in school, applied by a previously trained caregiver, and the other application at home, applied by someone responsible for the volunteer. Participants were unaware of which substance was being used (“blind” study). All assessments were performed by a single calibrated examiner (kappa = 0.88).

One squirt was applied to each right/left teeth group (right molars; incisors; left molars), amounting to three squirts in the maxilla/mandible on the buccal region and three squirts in the in the maxilla/mandible on the lingual/palate of the same teeth group totaling six squirts in each arc, for 60 days. The total volume of application was 12 squirts (1.5 mL).

All the participants received lectures on oral hygiene instruction with demon-stration, supervised tooth brushing, and the distribution of two hygiene kits per patient (one for school use and the other to be used at home). All caregivers were instructed how to use the spray.

All participants received nonsurgical periodontal treatment, the subgingival and supragingival calculus was removed with an ultrasonic device, and oral hygiene instruction was performed. After obtaining the parameters (Basal: before periodontal treatment and postinstruc-tion: after periodontal treatment and instructions), oral prophylaxis was performed with pumice and water with the aid of a low speed brush, so that all the patients could initiate testing under

the same conditions. The use of chlo-rhexidine and placebo was initiated immediately after the end of this step.

Throughout the experimental period, brushing was performed without the use of toothpaste. The assessment of oral hygiene was performed following the criteria used in the simplified oral hygiene index (OHI-S) proposed by Greene and Vermillion.14 The OHI-S is a combination of visible plaque and oral calculus. The labial surfaces of teeth 16/55, 11/51, 31/71, and 26/65 were examined and the lingual surfaces of teeth 36/75 and 46/85 after plaque dis-closing with fuchsin solution applied to cotton swabs, whose scores ranged from 0 to 3. To assess the degree of gingival inflammation the gingival index (GI) proposed by Löe and Silness was used.15 One tooth from each dental sextant was evaluated: 16/55, 11/51, 26/65, 36/75, 31/71, and 46/85. The degree of gingival inflammation was checked, according to the presence or absence of bleeding on probing, and assigned scores from 0 to 3. The OHI-S and GI were obtained before the onset of the experiment and compared to 7, 15, 30, and 60 days.

Analysis of the distribution of gender and age between the groups was performed using Fisher’s exact test and unpaired t-test. A comparison of the scores of OHI-S and GI in both groups at each time of evaluation was performed with the Mann-Whitney test. To compare the time points in each group the Friedman test was used. The significance level used for the tests was 5% (p < 0.05).

Resu l t sThe group that was initially evaluated was composed of 30 individuals; how-ever, when the study started, each group lost two members due to nonattendance for examination, making a final sample of 26 volunteers. Considering the varia-bles of gender and age, there was no statistical difference between groups. There were no differences between the OHI-S and GI after the oral hygiene instruction prior to the start of the experiment (Tables 1 and 2).

The groups showed no significant differences (Mann-Whitney test) at base-line (p = 0.801) and postoral hygiene instruction period (p = 0.840). However, the group that used chlorhexidine showed lower average OHI-S scores with significant differences compared to the placebo group at 7 days (p < 0.001), 15 days (p = 0.004), 30 days (p < 0.001), and 60 days (p = 0.001) (Table 2).

Comparison of mean OHI-S scores at different periods for the chlorhexidine group showed significant differences, considering the postinstruction evalua-tion and at 7 days (p < 0.05). However, comparisons between the postinstruction periods showed no significant differences after 15, 30, and 60 days (Friedman test and Wilcoxon test). The placebo group showed no significant differences between the evaluation periods (p = 0.659) (Table 2).

For the GI, there were no significant differences between groups in any of the postinstruction periods. Considering the evaluation of each of the groups in different periods, there were also no significant differences (p > 0.05) in rela-tion to postoral hygiene instruction (Table 2).

Those responsible for the volunteers at home reported that they observed no difficulty in using the spray; the patients offered no resistance to the treatment; 30% of patients in the chlorhexidine group complained about the taste of the solution; the treatment did not alter the routine of the family and the parents said that they would accept the use of the spray for long periods of time. There were no adverse effects on the oral mucosa and only two cases (15%) of staining of teeth through using the chlorhexidine (Table 3).

D i s cus s i onThe results of this study show that the 0.12% chlorhexidine solution, applied via spray significantly, reduced the rates of dental and gingival biofilm.

Similar conditions were established between groups, postinstruction. The placebo group remained with a high

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OHI-S level and no significant change during evaluations (p = 0.659). The experimental group (with chlorhexidine spray) showed a sharp drop in OHI-S, which was already observed in the evaluation after 7 days of product use (p < 0.05) and remained at stable OHI-S levels until the end of the evaluations, demonstrating the efficacy of .12% chlorhexidine applied via spray.

In the experimental group, 60 days after the application of .12% chlorhex-idine spray twice a day there was a 38% reduction in OHI-S. Considering the methodological differences in relation to the plaque index, the administration of the spray (performed by trained personnel or not) and the patients’ insti-tutionalised systems, it can be observed that regarding efficiency in controlling biofilm there was a 56% reduction,9 42% reduction,12 35% reduction,10 34% reduction,13 and 28% reduction.5 Thus, we found that our results were similar to those reported in the literature and that they were highly relevant.

Because chlorhexidine is a cationic substance that can have its effectiveness reduced by anionic substances (sulfates, phosphates, and anionic detergents) pre-sent in toothpaste during brushing, the whole experiment was carried out only with the use of a toothbrush without toothpaste.16

Some researchers consider that chlorhexidine is effective in controlling biofilm even in small volumes and they claim that there is no difference in the effectiveness of treatment with .2% chlorhexidine mouthwash administered via mouthwash and via spray.9,17 Consequently, the literature reports volumes administered via spray ranging from 1.20 to 1.40 mL, applied twice a day.9,10,13 It should be noted that this volume using the spray (1.5 mL) is smaller than the volume used in mouthwash, which would be difficult to administer to many of these patients.

The present study used a spray with a protractor, which featured a jet directed at the targeted teeth, avoiding pulveriza-tion, and having a higher safety level, among other advantages.8,10,12,13,18

Table 1. Subject demographic features.‡

Variables Groups

Placebo Chlorhexidine

Gender*

Female (%) 8 (62) 5 (38)

Male (%) 5 (38) 8 (62)

Total 13 13

Age (mean ± SD)† 10.7 ± 1.8 10.3 ± 2.4‡Four subjects discontinued the study.*Fisher’s exact test.†Unpaired t-test.

Table 2. Mean and standard deviation of OHI-S and GI values for the different evaluation periods.Periods OHI-S GI

Placebo Chlorhexidine Placebo Chlorhexidine

Basal 1.95 ± 0.61Aa 1.86 ± 0.65Aa 1.25 ± 1.01Aa 0.37 ± 0.54Ba

Postinstruction 1.83 ± 0.56Aa 1.75 ± 0.61Ab 0.69 ± 0.81Aab 0.22 ± 0.34Aab

7 days 1.97 ± 0.46Aa 0.98 ± 0.64Bc 0.34 ± 0.46Ab 0.16 ± 0.28Aab

15 days 1.92 ± 0.68Aa 1.23 ± 0.59Bbc 0.41 ± 0.56Ab 0.08 ± 0.19Ab

30 days 2.05 ± 0.53Aa 1.16 ± 0.47Bbc 0.66 ± 0.70Aab 0.13 ± 0.28Aab

60 days 1.87 ± 0.56Aa 1.16 ± 0.42Bbc 0.55 ± 0.56Ab 0.13 ± 0.17Aab

Horizontal different capital letters represent statistical differences between groups— Mann-Whitney test.Vertical lowercase letters represent significant differences in the same group at different periods of time—Friedman test with Dunn posttest.

Table 3. Responses to the questionnaire by those responsible for the volunteers at home regarding the acceptance and rejection to treatment of each studied group.Question Placebo (%) Chlorhexidine (%) p-Value

Did you have difficulty using the spray?

Yes 0 (0) 0 (0) –

No 13 (100) 13 (100)

Did your child resist using the spray?

Yes 0 (0) 0 (0) –

No 13 (100) 13 (100)

Did your child complain about the taste of the product?

Yes 0 (0) 4 (31) 0.096

No 13 (100) 9 (69)

Did you notice staining of the teeth?

Yes 0 (0) 2 (15) 0.480

No 13 (100) 11 (85)

Did the treatment alter the routine of the family?

Yes 0 (0) 0 (0) –

No 13 (100) 13 (100)

Would you use the spray over long periods?

Yes 9 (69) 0 (0) 0.001*

No 4 (31) 13 (100)

*Significant difference by Fisher’s exact test.

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Despite the fact that the use of chlorhexidine is considered by some researchers to be a temporary replace-ment for the mechanical removal of biofilm, supragingival biofilm is rather complex when analyzed by laser micros-copy. Through observation of the biofilm in situ and without rupture, there is a complex spatial and functional organiza-tion of these bacteria, penetrated by flow channels which connect the surface of the biofilm to the enamel and thus allow the diffusion of nutrients and oxygen, and the removal of dead cells, revealing a truly primitive circulation system.8,19

In this aspect, chlorhexidine remains restricted to the more superficial layers and does not provoke a disruption of this structure. Chlorhexidine will have its action hampered in relation to the deeper microorganisms in the biofilm, close to the surface of the teeth. Consequently, the mechanical disruption of plaque enhances the antigingivitis and anti-plaque effect of the chlorhexidine; therefore, it should be considered as an adjunct in the control of biofilm, associated with mechanical removal.6,19

To characterized periodontal conditions, numerous sites throughout both arches require a summary of the periodontal status over individual sites in the mouth. In this way, clinical examina-tions performed with a conventional periodontal probe could lead to limita-tions arising as a consequence of both the use of the instrument and the examiner regarding experience and repeatability measurements. It is also important to emphasize that the perio-dontal examiner was calibrated and trained to increase the reliability of the clinical findings observed in this study (kappa = .88).

Although some researchers work with patient groups with very different age groups, there is a consensus in the literature that there is a direct relation-ship between the severity of periodontal disease and age. Thus, there is a ten-dency toward the worsening of periodontal disease as the individual gets older. The present study evaluated patients aged 7 to 14, also carefully observed in other reports in the

literature, so that the experimental group did not differ from the control group in terms of age, thus ruling out the interfer-ence of this variable on the results.5,13,20

The studied sample had previously received basic periodontal treatment, which consisted of removing sub and supragingival calculus via ultrasound. In patients with poor oral hygiene, the presence of calculus is common and this certainly interferes with the performance of the treatments to which groups would be submitted. Thus, in the basal exami-nation of the GI in the present study it was observed that the levels were quite reasonable, in view of the patient population with mental health issues.

After the evaluated period, an improvement in the periodontal health of both groups was observed. As noted in Table 2, both groups showed significant changes during the evaluations.

Twenty-four gingival sites were examined for each patient in the experimental stages, so at the end of all the stages (basal index, postinstruction hygiene index, index at 7 days, index at 15 days, index at 30 days, and index at 60 days) 1,872 gingival sites in each group (chlorhexidine and placebo) were examined, totaling 3,744 sites examined during the whole experiment.

The experimental group (chlorhex-idine) showed an improvement of 90% in sites with gingival bleeding on probing, very close to the figure of 85%20 men-tioned in the literature. Other researchers found an improvement of 41.70%18 in bleeding sites and 50%21 improvement in gingival bleeding; such differences may be due to the use of professional prophy-laxis in the postbasal index phase and the posthygiene instruction index phase.

Despite the large methodological variation in the many studies in the literature, there is a consensus that chlo-rhexidine administered through spray is able to provide periodontal improvement and that such an outcome can be measured by gingival indices, or by a reduction in sites that bleed on prob-ing,5,8-10,12,13 a fact that was also observed in the present study by the reduction in bleeding sites. The effects of .2% chlorhexidine spray applied once a day

proved to be as effective as the twice daily application on the accumulation of plaque and gingival inflammation.22

Many researchers still report that a major side effect of chlorhexidine is its bitter taste, which means that treatment has to be restricted to short periods, which often leads to abandonment.2,7,11 The authors also evaluated at intervals of 7, 14, 30, and 60 days to monitor the progress of spray applications and to determine whether there were complica-tions resulting from staining and taste alterations, which might cause the patient to interrupt the procedure. However, when parents were asked whether their children complained about the taste of the product, only 30% con-firmed that this was the case, and 100% of this sample did not show resistance to the use of the product applied by spray and they also claimed to be willing to use the product for a long period. Another side effect of chlorhexidine discussed in the literature is brownish staining of the teeth. However, in the present study only two cases showed these characteristics, i.e., 15% reported small areas of staining that appeared after 30 days of using the spray, which was removed easily by dental prophylaxis.7,18,19

Thus, the side effects were mild and temporary; during the 60 days of the experiment no parent/caregiver discon-tinued treatment. The dropouts from the experiment were due to failure or breakage of the spray bottle, and given the impossibility of a quick replacement these patients had to leave the experi-ments. The side effects of chlorhexidine were avoided by the low concentration that was used and the small volume of solution dispersed by the spray.9,10,12

Anxious to present caregivers and those responsible for the volunteers at home with a proposal to supplement oral hygiene practice that would not alter the family routine, we questioned parents about the difficulty of applying the spray and 100% of them stated that they did not find it difficult to follow instructions and that they did not need to change their routine. These data were very important to meet the needs of those who care for patients with special

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needs,11-13,16 especially those with mental health issues.

Chlorhexidine has shown its effec-tiveness in controlling biofilm and gingival inflammation. The use of chlo-rhexidine spray is practical and effective, and it minimizes the side effects of chlorhexidine. Nevertheless, small accumulations of biofilm still persist, especially in cervical one-third of tooth surface, and they continue to contribute to gingival inflammation, a fact that requires a major incentive for mechanical removal in combination with chemical control of plaque.13,18

Conc l u s i onThe use of .12% chlorhexidine applied via spray reduced the rates of dental and gingival plaque (biofilm) compared to a placebo in individuals with mental health issues. Both caregivers and those respon-sible for the volunteers at home were prepared to use solution in spray form for a long period and the patients did not show resistance to the method used.

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Chlorhexidine spray as an adjunct in the control of dental biofilm in children with special needs