Journal Minimum Intervention In Dentistry

JournalOfMinimum Intervention In Dentistry

J Minim Interv Dent 2008; 1 (2)

152



153

Abstract

The objective of this study wasto evaluate the incidence ofadverse effects related byadolescents following 14 days ofuse of a mouthrinse containing0.05% NaF+0.12%chlorhexidine. The adolescentsenrolled to the study wererandomly divided into twogroups to use either: 0.05%NaF+0.12% chlorhexidine (G1,n=85) or 0.05% NaF (G2, n=85).Both groups used a 10ml solutionof the mouthwash during 1minute daily for 2 weeks undersupervision. After that period,the subject’s acceptance of tastewas measured using a verbaldescriptive scale (LabeledMagnitude Scale - LMS).Participants were alsointerviewed regarding theoccurrence of possible adverseeffects during treatment(temporary palate disorders,tooth-staining or unpleasanttaste). The proportionaldifferences between the groupswere tested using the chi-squaretest. Palate changes werereported by 26% of participantsof each group; 17.7% of G1 and32% of G2 reported anunpleasant taste (p = 0.062),while staining was reported by55% of G1 and 68.9% of G2 (p =0.117). Absenteeism rates weresimilar in both groups (G1= 2.58± 2.69; G2=2.81 ± 2.39),p=0.362. Conclusion: adherencewas high in both groups and sideeffects reported by subjects werenot perceived by them as being

important. Since subjects’acceptance and compliance isfundamental to the success of anoral health program,chlorhexidine-fluoride could be auseful resource in a program ofplaque control. First published in JAppl Oral Sci 2006; 14: 291-6.

1 Department of Stomatology, FederalUniversity of Santa Catarina.

2 Department of Public Health, FederalUniversity of Santa Catarina.



Address of first author:Dr. Ana Rita Duarte Guimarães - Tv. MagnoValente, 68/403 - Loteamento Aquarius,Pituba 41810-770 Salvador, BA, Brazil. Tel+55 (71) 3358-3096 – e-mail:[email protected]

Introduction

The chemical control of plaque canbe a useful resource in a subgroup ofpatients whose mechanical controlbecomes difficult and ineffective1-4.An antimicrobial agent should inhibitthe adhesion stage of bacterialcolonization, and affect the growthand metabolic activity of dentalplaque, without, however, interferingwith any other biological process. Inaddition, its toxicity must be low,since such solutions could beinadvertently swallowed5. Theenhancement of the cariostatic effect

Self-perception of side effects by adolescents in achlorhexidine-fluoride-based preventive

oral health program

Guimaraes A R1, Peres M A2, Vieira R3, Ferreira R M4,Ramos-Jorge M L1, Apolinario S4, Debom A4.



154

of the fluoride by its combinationwith antimicrobial agents has beensuggested4 and this combination hasbeen shown to be effective inarresting caries lesions in irradiatedpatients with minimal salivarybuffering capacity due to lower salivaflow rates4

Chlorhexidine is the mostcommonly used antimicrobialsubstance because of its provenefficacy in altering membranefunction, controlling oral biofilm andinhibiting the metabolism ofmicroorganisms. In addition, itinterferes with the acid production ofdental plaque, reducing the pH levelduring cariogenic challenges6.

On the other hand,chlorhexidine is known to causecertain adverse effects directlyrelated to higher concentrations7,long-term regimens7,8, andundisturbed biofilm. Consumption ofsome chromogenic agents9, such ascoffee or tea, for example, may alsoincrease toothstaining9, which is oneof the most recognized problemsassociated with chlorhexidine.Cationic antiseptics, such aschlorhexidine, may activate anionicchromatic particles contained insome food and drinks, causinginteraction with tooth surfaces10. Invitro, these colored particles canproduce identically coloredcomplexes such as those caused bychlorhexidine and observed clinicallyin individuals who drink tea, coffee orred wine compared with those whodo not ingest these drinks9.Randomized controlled clinical trialshave shown that tea and coffeeassociated with the use ofchlorhexidine mouthrinses contributesignificantly to staining the teeth andtongue. On the other hand,abstaining from tea and coffeenotably reduces this effect9. Inaddition, the bitter taste ofchlorhexidine and the temporaryreduction in the subjects’ perceptionof bitterness and saltiness11,12 couldcompromise their adherence to a

program based on this antiseptic.Moreover, loss of taste could reducepatients’ capacity to distinguishpossible toxic foods, and maydecrease their appetite. However,no serious adverse effects associatedwith the use of chlorhexidinemouthrinse have been reported inclinical trials5. However, there is apaucity of data in the scientificliterature concerning the incidence ofadverse effects related by subjectsusing a mouthrinse containing 0.12%chlorhexidine and 0.05% sodiumfluoride in a single solution. Thisassociation has been used as anadjunct to oral hygiene3, in thecontrol of active carious infection inhigh-risk patients1, in handicappedchildren2, orthodontic patients13,14,irradiated patients4, lymphomapatients receiving cytostatic drugs15,persons with disabilities2,16 and in theelderly17-19. Therefore, the purpose ofthis study was to estimate theprevalence and intensity of adverseeffects in patients using amouthrinse containing 0.05% sodiumfluoride or the combination of 0.12%chlorhexidine solution and 0.05%sodium fluoride after fourteen daysof use.

Material and methods

This current study was part of alarger, therapeutical, randomized,double-blind, clinical trial of whichthe main objective was to comparethe effectiveness of 0.05% sodiumfluoride alone (NaF) and thecombination of 0.12% chlorhexidinesolution (CHX) and 0.05% sodiumfluoride in arresting active cariouslesions after 14 school days20.Carried out within the randomizedclinical trial, the objective of thisstudy was to evaluate the occurrenceof side effects during the use ofthese mouth-rinses. The study wascarried out in a public school inFlorianópolis, capital of the Brazilianstate of Santa Catarina.



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Individual selection and eligibilitycriteria

Children with at least one activewhite spot carious lesion in smoothenamel surfaces were enrolled to thestudy. Exclusion criteria comprisedschoolchildren who were taking somemedication, those in use oforthodontic brackets or dentalprosthesis, those who had undergoneaesthetic tooth restoration, andpregnant or breastfeeding girls. Asample size of 71 individuals, 11-15years of age, was required for eachgroup. An additional fifteen percentwas added to each group tocompensate for possible dropouts;therefore, 82 individuals wereenrolled to each group. The Epi Infosoftware program21 was used tocalculate sample size. The criterionfor statistical significance was set atP < 0.05.

Personnel and Training

Eight previously trained dentalstudents, supervised by a dental PhDstudent (MLRJ), provided bothgroups with mouth-rinses in identicalplastic cups. Three dental students,also previously trained, asked thechildren questions regarding theirperception of adverse effects. Dentalstudents and the children wereblinded with respect to the contentsof the solution.

Randomization and blinding

A double-blind study was carried outand subjects were randomlyallocated to one of two groups:Group 1 (G1 – 0.05% NaF + 0.12%CHX) or Group 2 (G2- 0.05% NaF). Arandomisation method was used toform the groups. A number wasgiven to each eligible child and thenput into a sealed opaque envelope.The envelopes were randomlyselected by the supervisor (MLRJ) toallocate the individuals to each groupof mouth rinsing solution, either0.05% fluoride or 0.05% plus 0.12%chlorhexidine. Two pure solutions

containing the same pharmacologicalformulation were used, the onlydifference being the presence orabsence of 0.12% chlorhexidine insolutions A and B, respectively20. Thesolutions were in identical,unlabeled, amber-colored bottles,bearing only the codes A or B.Neither the eligible children, themouthrinsing supervisors or theexaminers knew to which group thechildren belonged.

Dental examinations werecarried out at baseline and afterfourteen days of treatment. Prior tothe examinations, the children wereasked to brush their teeth under thesupervision of the dental studentsusing toothbrushes provided by thestudy.

Mouthrinsing

The children were instructed by theteam to rinse during 1 minute/dayfor 14 consecutive school days usingthe 10 ml solution provided in plasticcups. The components common tothe two solutions were 0.05%sodium fluoride, glycerin, non-cariogenic anise aroma, blue foodcolouring, preservative and vehicleqsp. The solutions were preparedexclusively for the study (Fórmula &Ação, São Paulo) and both solutionshad identical color, flavour andartificial taste. The toothbrushingwas performed without the use oftoothpaste since Brazilian dentifricescontain SLS (sodium laurylsulphate), which inactives CHX,thereby requiring a minimum intervalof 30 minutes between toothbrushingand rinsing22, which would be anunreasonable interruption of theschoolchildren’s routine. Although aneffect of fluoridated water,concentration of water fluoridatedand dentifrice in the arrestment ofdental caries was expected, bothgroups were randomly exposed tothese variables and any influenceshould therefore have beendistributed randomly.



156

Interviews

To evaluate subjects’ perception ofthe side-effects caused by eithertreatment, only one examiner (RMF),who was aware of the objectives ofthe study, carried out all theinterviews. After 14 days of rinses,the children were screened for theirability to assign a bitterness intensityrating to each solution, using asimplified scale based on the“Labeled Magnitude Scale” (LMS)23.The method used to estimate theimpact caused by side effects relatedto the solutions was subjective.However, the instrument used is anadaptation of the Labeled ScaleMeasurement (LSM) that has beenwidely used in physiologicalscience23. The instrument underwentprevious validation in the Portugueselanguage and was adapted to thelocal culture to ensure optimalcomprehension by the studypopulation (Figure 1).

This scale is a method used forobtaining estimates of intensity. Themethod consists of a line (usuallyvertical) with verbal descriptions ofintensity, using adjectives todescribe intensity that ranged fromweak, moderate, strong and verystrong to the strongest imaginablesensation. Afterwards, theadolescents stated whether theperceived intensity was acceptable ornot. They were also asked aboutpossible adverse effects occurringduring or after that period, such astransitory alterations in the patient’sperception of taste during orfollowing the test period, any changein the appearance of teeth perceivedby the subjects, as well as questionsrelated to weekly consumption ofstaining products such as tea, coffee,colored snacks, Coca-Cola , othersoft drinks, cigarettes andchocolates. Stain was evaluated in adichotomy way considering itspresence or not after the test period.All natural teeth in the dentition wereincluded.

Figure 1. (LMS) Labeled measurement scale



157

Data analysis

To test the methodology, a pre-testwas performed in a sample of 30adolescents, whose characteristicswere similar to those of the studypopulation. Absenteeism wasmeasured daily and was defined asbeing when a student failed to carryout the scheduled mouth-rinsing ordid not attend the final clinicalexamination.

Both dental examinationswere carried out by the sameexaminer (ARDG). After the seconddental examination, all new toothstaining that had not been registeredat the first examination wasrecorded. The examiner did not knowto which group the adolescentsbelonged.

The Mann-Whitney U and Chi-square tests were used to assessdifferences in variables between thetwo groups at baseline and at theend of the trial. The differencesbetween proportions were testedusing the chi-square test andcomparison in the perception oftooth-staining was analyzed usingFisher’s exact test.

Significance was established whenp<0.05. The SPSS software package(SPSS, Chicago, Illinois, USA) wasused for the data analysis.

Results

Eighty-five adolescents were enrolledin each group and participated in thestudy. There were no statisticallysignificant differences in gender orage between adolescents in the testgroup (0.05% sodium fluoridecombined with 0.12% chlorhexidine– G1) and those in the control group(0.05% sodium fluoride mouthrinsealone – G2), (Table 1). Absenteeism,which could have modified theresults, was almost identical in thetwo groups studied (Table 1).

Temporary taste disorderswere perceived by exactly 26% ofstudents in each group; unpleasanttaste by 17.7% of participants of G1and 32.3% of G2 (p = 0.062), andstaining by 55% of G1 and 68.9% ofG2 (p = 0.117), (Table 2). Thestaining was easily removed byprofessional dental prophylaxis.

Characteristics G1 (n=85)

(%)

G2 (n=85)

(%)

p

Female participants

Age (years) – mean (SD)

Absenteeism – mean (SD)

55.3

13.01 (1.34)

2.58 (2.69)

58.8

12.96 (1.38)

2.81(2.39)

0.64 *

0.88**

0.362**

Table 1. Differential aspects of both groups at baseline

SD = Standard deviation; * Chi-square test; ** Mann-Whitney U test



158

There was no difference in theconsumption of colored snacks,chocolates, juices, Coca-Cola , othersoft drinks, tea or colored flavoringbetween the two groups. However,coffee consumption was higher in thetest group (G1) than in the controlgroup (G2). The consumption of teawas slightly higher amongparticipants in the control groupcompared to the test group (Table3). None of the subjects reportedcurrent tobacco use.

Regarding patients’ perceptionof tooth-staining, there was adiscrepancy between the subject’sperception and that of the studydentist in ten cases, the dentistnoticing the tooth-staining morefrequently than the adolescent (Table4). Browning stain was usually foundon the cervical third of anteriorteeth.

Discussion

Considering the widespread use ofchlorhexidine in dentistry, there arefew reports of side effects, otherthan some local effects such asdiscoloration of teeth, tongue,restorations and dentures7,9,10,24, andtemporary taste disorders, principallyrelated to the 0.2% rinses11,17. It isdifficult to compare the results of thispresent study with results fromprevious randomized clinical trialsdue the variability of fluoride andchlorhexidine combinations,concentrations, pharmaceuticalpresentation (gels, varnishes orrinses), and the presence or not ofboth elements in the same product.

In a previous randomized clinical trial(RCT)4, chlorhexidine associated withfluoride in the same productachieved excellent patientacceptance and adherence in a dailymouthrinse program (0.05% NaF -0.2% CHX) and tooth staining wasnot reported by the users ofchlorhexidine. In another study,staining was intensified after 6months of use of 1% CHX-Ftoothpaste, but the programparticipants considered the local sideeffects acceptable7. The acceptabilityand tolerability of chlorhexidine andbenzydamine oral rinse agents usedin a protocol on oral hygiene inchildren receiving chemotherapy wasevaluated and both agents wereacceptable and well-tolerated bychildren over the age 6 years old25.However, these studies useddifferent regimes from those used inthe current trial.

In this study, subjectabsenteeism was very low and didnot differ between the two groups,indicating high adherence to theprogram. It is, therefore, reasonableto speculate that the use of CHX-Fcould be recommended as aprocedure for plaque control.

A similar number of subjectsin both groups (26%) reportedtemporary taste disorders, reflectingthe successful randomizationprocedure. A greater proportion ofsubjects using the fluoridatedsolution (G2), (32.3%), related anunpleasant taste when compared tothose in the CHX-F solution

Related Side Effect % G1 (n=85)

(%)

G2 (n=85)

(%)

p

Temporary taste disorders

Unpleasant taste

Staining

26

17.7

55

26

32.3

68.9

ns**

0.062*

0.117*

Table 2. Chi-square test for the perception of the side effects on both groups

*Statistical significance (p < 0.05) **ns = not significant



159

group (G1), (17.7%), indicating thatthe anise flavour contained in bothsolutions successfully masked anyunpleasant taste. Moreover, thesubjects reported the taste as beingstrong but refreshing and stated thatit gave them the sensation of oralcleanliness. In addition, theadolescents perceived the changes intooth color as being somethingpositive, probably associated withthe therapeutic effect of the twosubstances.

There was no statistically significantdifference between the two groupswith respect to the consumption ofany of the staining agentsinvestigated (Table 3),demonstrating the homogeneity ofthe two groups. Coffee consumptionwas higher than tea consumption inboth groups and there was adiscretely higher consumption in thechlorhexidine-fluoride group. Theseresults hindered the comparison withprevious studies in which coffee wasshown to stain teeth less than tea9.

Food /beverage G1

Mean (SD)

G2

Mean (SD)

p

Colored Snacks

Chocolate

Juices

Coca-Cola

Other soft drinks

Coffee

Tea

Colored seasoning

2.00 (0.30)

2.58 (0.30)

3.67 (0.32)

3.64 (0.27

3.00 (0.33)

3.69 (0.43)

1.03 (0.26)

2.67 (0.47)

2.57 (0.28)

2.89 (0.32)

3.40 (0.33)

3.37 (0.23)

2.80 (0.30)

4.77 (0.36)

0.46 (0.17)

3.34 (0.46)

0.194

0.499

0.623

0.264

0.477

0.037

0.075

0.233

Table 3. Mann Whitney U test for the consumption frequency of possible staining agents reported bythe adolescents

< 0.05)

Tooth-staining

Dentist’s perception

yes no

Total

Tooth-staining

Subject’s perception yes

n

% perceived

6

100%

6

100%

no

n

% perceived

10

34.5%

19

65.5%

29

100%

Total n

% perceived

16

45.7%

19

54.3%

35

100%

Table 4. Fisher’s exact test for the comparison of professional and subjects` tooth staining perception



160

Cigarette smoking was notmentioned by any subject in eithergroup.

To demonstrate whethertooth-staining was correlated withthe solution, the perception of thesubjects themselves was comparedwith the perception of the studydentist. All cases of tooth-stainingperceived by the dentist were causedby the chlorhexidine-rinse, and theseresults are in agreement withprevious reports3,9,10, confirmingchlorhexidine as a tooth-stainingagent. On the other hand, althoughthe adolescents reported theoccurrence of a few cases of tooth-staining, it did not seem important tothem and did not affect theirparticipation in the program.

Another aspect that should beconsidered is the possibility of theparticipants being psychologicallybiased in favor of the treatment.However, this possibility is minimalsince participants were just as likelyto be randomized to either treatmentgroup.

Therefore, the inherentcharacteristics of the study design,such as randomization and blinding(subjects, dental examiner andinterviewer), which avoided any biasin variables, confirm its suitabilityand validate our findings. For thesame reason, the occurrence oftooth-staining was recorded duringthe dental examinations in an effortto guarantee that only tooth-stainingrelative to the treatment wasanalyzed. Another positive feature ofthe study design is the adequatesample size that enables the resultsto be extrapolated to a largerpopulation and confers externalvalidity to the study. In addition, it isimportant to remember that theduration of the study was sufficientto detect possible side effects and toobserve the high rate of compliancein both groups.

Conclusions

Adherence was high in both groupsand side effects perceived bysubjects did not appear relevant tothem. Since patient compliance wasconsidered highly satisfactory andthe side effects perceived by thesubjects did not seem important tothem, the use of chlorhexidinecombined with fluoride may berecommended as an auxiliaryresource in plaque control.

Acknowledgments

This study was supported byFUNPESQUISA (337/2002, UFSC,Brazil). The authors would like tothank the dental students whohelped them during the fieldwork andAna Nere Santos for her technicalsupport. The authors would also liketo thank the local educationauthorities and teachers. Condor S.A.kindly provided the toothbrushesused in the study. As the solutionswere specifically prepared for thestudy, there was no conflict ofinterest that could influence theresults.

0.05%NaF+0.12%

142

0.05% NaF+0.12%(G1, n=85)

0.05% NaF (G2, n=85)10ml

1 2Labeled

Magnitude Scale -LMS

26%



161

G1 17.7% G232% p =

0.062 G1 55% G2 68.9%p = 0.117

G1= 2.58 ± 2.69;G2=2.81 ± 2.39 p=0.362

-

J Appl Oral Sci 2006; 14: 291-6

Resumen

El propósito de este estudio, fueevaluar la incidencia de efectosadversos relatados poradolescentes luego de haberutilizado durante 14 díasenjuague bucal con un contenidodel 0.05% de NaF+0.12% declorhexidina. Los adolescentesinscritos para el estudio, fuerondivididos al azar en dos grupospara usar ya sea 0.05%NaF+0.12% clorhexidina (G1,n=85) ó 0.05% NaF (G2, n=85).Ambos grupos usaron, bajosupervisión, 10ml de solución delenjuague bucal, por espacio de 1minuto diario y durante 2semanas. Luego de ese periodo,se midió la aceptación de sabordel individuo utilizando unaescala descriptiva verbal(Labeled Magnitude Scale - LMS).Asimismo, se entrevistó a losparticipantes con respecto a lapresencia de posibles efectosadversos durante el tratamiento(trastornos temporales delpaladar, decoloración del diente,o mal sabor). Se probaron lasdiferencias proporcionales entrelos grupos utilizando la pruebade X2 o ji-cuadrado. En cadagrupo, el 26% de losparticipantes reportó cambiospalatales; el 17.7% del G1 y 32%del G2 informó de mal sabor (p =0.062), mientras que el 55% delG1 y 68.9% del G2 (p = 0.117)informó de decoloración. Laproporción de absentismo fue

similar en ambos grupos (G1=2.58 ± 2.69; G2=2.81 ± 2.39),p=0.362. Conclusión: laadherencia fue alta en ambosgrupos, y los participantes nopercibieron como importantes losefectos secundarios que ellosmismos reportaron. Dado que laaceptación y conformidad de losindividuos es fundamental parael éxito de un programa de saludoral, la combinación declorhexidina y fluoruro podría serun recurso útil en un programade control de placa. Publicadoprimero en J Appl Oral Sci 2006; 14: 291-6.

Resumo

Objetivo: Este estudo se propôs acalcular taxa de efeitos adversosapós 14 dias de uso de soluçãode bochecho de NaF 0,05% +clorexidina 0,12% realizados poradolescentes. Métodos: Esteestudo duplo-cego foidesenvolvido como parte de umensaio clínico randomizado. Osadolescentes foram divididosaleatoriamente em dois grupos:NaF 0,05% + clorexidina 0,12%(G1) ou NaF 0,05%, (G2) de 85estudantes cada quebochecharam diariamente, 10mlde solução sob supervisão,durante 1 minuto, por 2semanas. Após esse período, aaceitação dos participantes aogosto das soluções foi avaliadaatravés de uma escala descritivaverbal - (LMS)11. Os participantesforam entrevistados tambémquanto a possíveis efeitosadversos acontecidos durantetratamentos (desordenstemporárias de paladar,manchamento dental e o gostode soluções desagradáveis). Asdiferenças entre proporções emambos os grupos foram testadaspelo teste do qui-quadrado.Resultados: Alteração de paladarfoi informada por 26% dosestudantes de cada grupo;



162

17,7% dos G1 e 32% do G2notaram o gosto desagradável (p= 0,062) e manchas por 55% dosG1 e 68,9% dos G2 (p = 0,117)taxas de absenteísmo foramsemelhantes (G1 = 2,58±2,69;G2=2,81(2,39), p=0,362.Conclusão: A aderência dosparticipantes foi alta e os efeitoscolaterais percebidos nãopareceram importantes pelosadolescentes nos dois grupos.Implicação pratica: A aceitaçãodos participantes aos agentespreventivos utilizados e suaaderência a qualquer programade saúde bucal contribuem parao seu êxito).

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