Penodontics

The effect of salt-containing dentifriceson gingivai infiammation

Linda Watermann, DMDVChristiane Gleissner, MD, DMDVMichel ThulVBrita Willershausen, DMD'

Objective: This study examined the effect of an alkaline, salt-confaining toothpaste, a tocthgel of simiiarcontents, and a conventionai toothpaste on gingival infiammaticn. Method and materials: One hundredfifteen patients suffenng from mild to moderate chronic gingivitis were enrolied in a doubie-biind clinicaiStudy. Ail subjects had at least 20 teeth, probing depths of iess than 6 mm, and a suicular blgeding indexof 50% or moro, Af the beginning of fhe study period, the subjeots were randomly assigned to 3 studygroups. The baseline examination recorded the number ct decayed, missing, and fiiied teeth, an approxi-mal piaque index, a suicuiar bleeding index, and the gingival índex. Results: After an 8-week study pe-riod, statistically significant reductions in the piaque and bleeding indexes were observed in ali 3 groups.There were no significanf differences among fhe 3 dentifrices examined. Conclusion: The effectivenessof salt-containing denfifrices in patients with gingivitis was comparabie to that of a conventional tcoth-paste, (Quintessence Int 2000;31:117-124)

Key words: dentifrice, Emser Sait, gingivai inflammation

CLINICAL RELEVANCE: Salt-containing dental productsseem to be another apprcpnate means of daily prophy-lactic care for patients with pericdontal diseases.

Gingivitis is a widely distributed, very commonform of periodontal disease. The prevalence of

gingivitis in children and adults varies between 6O°/oand 100"o, As demonstrated by the human gingivitismodel introduced by Loe et aL' the role of bacterialpiaque in inflammatory gingival reactions is well es-tablished, A large number of animal and human stud-ies have proved that a thorough mechanical tooth-cleaning can inhibit plaque accumulation and calculusformation as well as exert a positive influence on thebacterial oral microflora.-

Several authors have demonstrated a lack ofknowledge concerning the etiology and prevention ofgingivitis' among Europeans and Americans,Because prophylactic denta! measures alone do notproduce a desirable standard of oral hygiene, itseems reasonable to search for alternative means andfo provide patients with supplementary tools for

'Department of Restorative Dentistry, Johannes Gutenberg Universily.Main:, Germany.

Reprint requests: Dr Línüa Watermann, Department of RestorativeDentistry, Johannes Gutenberg tjniversitat t^ilainz, Augjstuspiatz 2, D-5513f Mainz, Germany, Fax' 49-06t3t-t 73406,

daily denta! care. Mechanical and chemical methodsare available to inhibit plaque formation," Dentifricesand mouthrinses are important adjuvant means ofplaque control, useful in the prevention of caries andperiodontal disease. Toothpastes have been used formore than 2,000 years. Today, high-technology for-mulas provide maximal cleaning efficiency and toothprotection.

Important reasons for using a dentifrice are theimprovement of the mechanical brushing process,the restoration of the natural shimmer of the toothsurface, and the application of therapeutically or pro-phylacticaliy effective substances,*^ Chiorhexidinedigluconatc has been shown to produce substantialreductions in microbial plaque in numerous clinicalstudies,' Several well-documented side effects, suchas denta! and mucosal discoloration, mucosal desqua-mation, and disturbance of the sense of taste, haverestricted the indications for and the long-term use ofchiorhexidine. Alternative chemical means of plaquecontrol have been sought.

Apart from herbal substances, the effectiveness ofwhich is controversial, a new substance, triclosan,which has shown effective plaque-Inhibiting proper-ties, has recently been introduced to the market,*""Although it exerts a broad antimicrobial effect, tri-closan has rather low antiplaque activity, necessitatingits combination with adjuvants such as polyvinylmethylcther-maleic acid copolymers to improve thebonding of the substance to oral surfaces and thus

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TABLE 1 Composition of dentifrices used in thestudy

Dentifrice

Emsertoothpaste

Emser gel

Dentagard(control)

PEG = poiyethy

Saltconcentration Composition

5% Emser Salf Water, xylitol.Emser Salt, silica,1,2 propandiol.glycerin, cellulosegum, natural aroma.sodium iauryl sulfatedisodium nionofluoro-phosphate, titaniumfluoride

10% Emser Salt' Water, xylitol, EmserSalt, silica, 1,2propandiol, glycerin.PEG-8, cellulose gum.natural aroma.sodium lauryl sulfatedisodium monofluoro-phosptiate, CI 75810Water, sorbitol.tiydrated silica.glycerin. PEG-12.cellulose gum, aroma.sodium lauryl sulfate.bisabolol. commiptioramyrma, saliva offici-nalis, sodium fluoride.CI 74260, CI 7789

ene glycol. Cl ^ color identity•Oations: Na* (300 g/kg). K" (S g/t(g¡. Mg**, L i^ Ca*^ Rb*. Fe * \

(120g/kg¡.

increase the antibacterial effect,' Several authors havedemonstrated a positive effect of triclosan-containingdentifrices on gingival inflammation.'^'' However,clitiical reports of skin reactions followitig exposure totriclosan-containing toothpastes, those which alsocontain sodium lauryl sulfate and propylene glycol,have recently been published.'^

In the search for alternative substances, it should beemphasized that dentifrices used by patients with peri-odontal diseases should be alkaline, to disrupt the spe-cific pathogenic microflora in deep periodontal pock-ets.'* In the therapy of upper respiratory tractinfections, alkaline salt solutions have been provenvery effective, simple to manufacture, and inexpen-sive." Reports mentioning salts as therapeutic agentsin dentistry date back to antiquity: Hippocrates rec-ommended a mixture of salt, alum, and vinegar forpatients with oral diseases, wbereas Plinius used anaqueous saline solution.'* The therapeutic use of saltwater in the management of gingivitis duringpregnancy is an old household remedy. Folio andcoworkers" recommended the use of inorganic salts.

in combination wifh systemic tetracycline, durtngorthodontic therapy for patients with juvenile pert-odontitis.'** Recently, the regular use uf an isotonicsaline mouthrinse has been shown to reduce gingtvalinflammation and plaque accumulation in patientswith gingivitis, "

Only a few salt-containing dentifrices are availablein Germany. The leading brand among these mostlysea salt-containing dentifrices is Merfluan (ColgatePalmolive), which is put on the toothbrush in the formof a powder. A positive clinical effect of Meriluan inthe prevention of gingival inflammation has beendemonstrated.^'

The present study compared the anti-inflammatoryeffect of a dentifrice containing an alkaline salt to thatof a well-known, commonly used toothpaste.Although to date no difference in the cleaning effi-ciency of toothpastes and toothgels has been demon-strated,^^ a toothgel that contains alkaline salt wasalso included in the present study, because some pa-tients prefer gel dentifrices to paste dentifrices, citing asensation of oral freshness and cleanliness.

METHOD AND MATERIALS

Dentifrices

The salt-containing toothpaste and the saline toothgelwere each manufactured from a tnixfure of naturalsalt, originating from the thennal well in Bad Ems,Germany, and of synthetic Emser Salt (NRF, DAB 6).Natural and synthetic Emser Salt are considered phar-macologically effective substances. Natural Emser Saltis available on the German market as Emser Salt, It iswell known for its positive effect on inflammatory dis-eases of the upper respiratory tract. Synthetic EmserSah is manufactured by the pharmaceutical industry.The alkaline salt is a salt in the chemical sense of theword, but in contrast to sodium chloride or sea salt, itcontains fewer chloride ions and more sodium and hy-drogen carbonate ions.

The salt-containing dentifrice has a salt concentra-tion of 10''/o, and the dental gel has a salt concentra-tion of 5%. The pH values of these dentifrices are alka-line, between 8.5 and 9.0. The toothpaste and the gelwere compared to a standard, commercially availabledentifrice (Dentagard, Colgate Palmolive). The com-positions of all 3 dentifrices are reported in Table 1.

Patients

The aim of the study was to evaluate and compare theeffectiveness of home use of 3 dentifrices on gingivalinflammation and plaque accumulation in patients

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with gingivitis. To obtain a patient group showing awide range of clinical data, subjects were recruitedfrom patients visiting the Department of RestorativeDentistry at Mainz University for routine dental care,from patients attending a private practice for routinedental care, and by means of a notice displayed at theuniversity dental school. All probands presented withmild to moderate gingivitis, whieh was definedby means of a modified sulcular bleeding index (SBI)by Lange" (SBI > 500'b) and tbe gingival index (GI)according to Loe and Silness '' (GI > 1).

Patients with systemic illnesses and those receivingimmunosuppressive or antibiotic therapy wereexcluded from the study protocol, as were patientswith reduced dentition (fewer than 20 teeth), pro-found periodontal diseases (probing depths greaterthan 5 mm), orthodontic anomalies, or medicationinfluencing periodontal health (eg. nifedipine. cyclo-sporine, or diphenylhydantoin). Pregnaney was anadditional exclusion criterion for female patients.

The subjects were divided into 3 groups of similarsize. Neither the probands nor the examiner knew towhich group the proband belonged. Within groups,probands were elassified according to age and approx-imal plaque index (API) at the beginning of the studyperiod (modified API by Lange") to obtain compara-ble proband groups.

Experimental design

The probands received a leaflet with information onthe etiology of and the therapy for gingival diseasesand an explanation of the study protocol. Theysigned an agreement to use the materials given tothem throughout the study. They also agreed to par-ticipate in the reexaminations, scheduled for 2, 4,and 8 weeks after basehne. Within the study period,they were required to refrain from any other dentaltreatment.

The examination of the subjects at baseline eon-sisted of a general and specific patient bistory. includ-ing smoking bistory, tbe use of medication (nifedipine,cyclosporine, or bydantoin derivatives), and a thor-ough dental examination including the evaluation ofperiodontal conditions. All subjects received a profes-sional toothcleaning. including removal of calculusand polishing of all teeth, in addition to oral hygieneinstructions (3 times a day, modified Bass technique,"for 3 minutes). Identical toothbrushes [Ora!-B Indica-tor 35, medium soft) were given to all probands at thebeginning of the experimental period.

A double-blind design for tbe toothpaste tubes facil-itated the objective evaluation of the 3 dentifrices. Thedistribution of the dentifrices to the prohands was per-formed in a randomized manner.

Beyond the instruction of the patients on the studydesign and causes of periodontal disease, clinical andpatient-suppiied information was obtained from atotal of 4 examinations (baseline examination andcontrol examinations after 2, 4, and 8 weeks):

1. Baseline examination: Questionnaire (patient'shealth history, cigarette eonsumption, oral healthhabits), modified approximal plaque index, modi-fied sulcular bleeding index, gingival index, probingdeptbs, and mobility of the Ramfjord teeth

2. Control examinations after 2, 4, and 8 weeks:Modified API, modified SBI, and GI

At the 8-week examination, the patients were askedto eomplete a questionnaire on their acceptance of thetoothpaste or gel.

Clinical data collection

All of the clinical examinations were performed by thesame calibrated examiner. Tbe dental examination atbaseline included evaluation of the number ofdecayed, missing, and filled teeth,^^ tbe restorativematerials used, and possible prosthetie restorations.Furtbermore, probing depths and dental mobility wererecorded at the Ramfjord teeth.-' If a tooth was miss-ing, neighboring teeth of equal status were taken intoaecount. At every examination, the following clinicalparameters were monitored:

L A modified suleular bleeding index was deter-mined by gently probing tbe distal gingival sulcusof each tooth except the third molars with aWorld Health Organization probe. The preseneeor absence of gingival bleeding was recorded. Themeasurements were taken at the buccal approxi-mal sites in the maxillary right and the mandibularleft and at the palatal or lingual approximal sitesin the maxiilary left and the mandibular right halfof the dentition. The SBI was expressed as a per-centage of the number of measured sites that bledafter probing in relation to the total number ofsites measured.

2. To determine the approximal plaque index aplaque-diselosing agent (Oral-B 2-color plaque in-dicator) was used to distinguish fresh (pink) fromold (bitte) approximal plaque. The presence or ab-sence of plaque was recorded. The positions of tbemeasuring sites were tbe same as for the SBI. TheAPI was expressed as a percentage of the numberof measured sites with plaque in relation to thetotai number of sites measured.

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The gingival index, following the criteria describedby Loe and Silness, -' was determined at 6 points(buccal: mesial, midpoint, and distal; palatal/lin-gual: mesial, midpoint, and distal) on the Ramfjordteeth.-' Means were calculated for each tooth andeach proband at each exatnination and used in thestatistical analysis.

Statistical analysis

Means and the differences of the means were calcu-lated for the bleeding of the marginal gingiva (SBI).gingival inflammation (GI), and plaque accumulation(API) for each group at each examination. The datawere tested for significance by means of the Mann-Whitney (Wilcoxon) test, the chi-square test, or theICruskal-Wallis test. The significance level was 5%.

RESULTS

Of the 120 subjects enrolled in the study, 115 weremonitored over the entire study period. Four patientsquit without giving reasons, and 1 patient complainedabout increasing thermal sensitivity. The mean ageof the female probands was 31.ö years, and themale probands averaged 31.8 years. No statisticallysignificant differences among the groups were foundat baseline.

Plaque

All 3 dentifrices reduced plaque accumulation. Plaqueformation, as measured by the API at baseline, wascomparable in all 3 groups. The highest plaque reduc-tion over the 8-week period of ihe study was observedin the patients who used the dentifrice containing 10%Emser Salt. However, the differences among thegroups were not statistically significant (Fig 1).

Gingivitis

Similar effects were observed by monitoring of gingivalbleeding (SBI and GI), which showed a significant re-duction in all 3 groups. Again, the differences amongthe 3 dentifrices were not statistically significant. Thesalt-containing gei was just as effective as the conven-tional toothpaste in reducing gingival bleeding (Fig 2).The conventional toothpaste showed the best results inthe reduction of the gingival index (Fig 3).

In all 3 groups, the SBI and GI values showed thegreatest reduction during the first half of the study.During the last 4 weeks of the study, a slower reduc-tion of gingival inflammation was noted. For the salt-

Fig 1 Reduotion in apprcximai piaque index (API), Emser tooth-paste group demonstrated the greatest tendency tor piaque re-duction over the 8 weeks of the study; however, no statisticaiiysignificant ditferenoe among the groups was established.

containing gel and dentifrice, a slight increase in theSBI and GI values was demonstrated.

Acceptance of the dentifrices

The conventional dentifrice had slightly better ratingsfor taste than did the salt-containing gel [Fig 4). ThelO /o salt-containing toothpaste received the worst rat-ings, probably because of the salty taste.

The subjects gave similar ratings for the cleaning ef-ficiency of all the dentifrices [Fig 4). However, thedental gel received slightly lower values. This observa-tion was confirmed by several probands who com-plained of low foam development, which they assumedwas an indication of lower cleaning efficiency.

In smokers, the positive effect of the 3 dentifriceson plaque accumulation and gingival conditions wasreduced. However, the most significant API reductionin smokers was found in the group using the salt-con-taining toothpaste (Fig 5).

DISCUSSION

The causal relationship between the accumulation ofplaque and the development of gingivitis is undis-puted, Frandsen^'' was able to show that regular me-chanical toothcleaning results in a reduction of plaqueaccumulation, Willershausen et aF' showed, in a com-parative study of recruits to the German army, that thesupplementary use of a mouthdnse has positive effectson gingiva! inflammation. The use of dentifrices, withtheir classic effects, such as toothcleaning and preser-vation, should intensify this effect, Gjermo andSaxton^" demonstrated that plaque and inflammationvalues can generally be reduced from 10% to 30% by

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Fig 2 Reduction in sulcuiar bieeding index (SBi). Emser tooth-paste produced the weakest resuits in tfie reductior) ot the ten-dency to bleed; the ettioiency ot Emser gel was abojt equal to thatot the controi (placebo] toothpaste.

Fig 3 Reduction in the gingival rndex (GI] The use of the controlIpiacebo] toothpaste (Dentagarfl) produced better ciinicai resultsfor the conditions of the gingiva than did either of the 2 salt-con-taining preparations It remains a matter of speculation whetherdeciinmg compliance on the part of the patients produced a re-newed increase in the Gi vaiues in the tinai weeks ot the study.

Taste of the salt-containing ge[Cleaning efficiency ot the

salt-containing gei

Taste ot thesalt-ccntaining toothpaste

Taste of thecontroi toothpaste

I Grade 1Grade 2

Cieaning efficiency of thesalt-containing toothpaste

Cleaning etticiency of thecontrol toothpaste

rade 3rade 4

• Grade 5• Grade 6

Fig 4 Acceptance of the products by the patients. The salt con-tent ot the Emser products significantly affected the patients' re-mariis on taste. The conttoi toothpaste received the best evaiua-lions on a scale from 1 (very good] to six {bad]. The Emser Saltpreparation, wilh a concentration ot 10%, was the saltiest denti-irice and received the worst ratings. The efficiency of cieaning wasjudged to be about the same for all 3 preparations.

40 -

30 -

:5- 20 •;

5: 10 - r

" 0 ^

-10

-20 i i

ilGel

1I 1

Paste

IPI rediiction |

1m_•_Placeb

11

Fig 5 Reiationship between smoking and reduction in approximalpiaque index (APi]. Consumption ot cigarettes had a negative ef-tect or) API reduction. Emser toothpaste was especially heipfui losmokers in reducing piaque accumulation.

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Fig 6a Initiai situation of a 21-year-oid patient with mild gingivitisiHard and sott piaque accumuiations, a consequence of poor oralhygiene, have produced inflammation of fhe gingiva The firstsfeps will be a professionai prophylaxis and instruction in oraliiygiene. Home oral hygiene afterward wiil be conducted evoiu-sively with 5% Emser Sait Gei.

Fig 6b Same patient after 2 months. The signs of gingivalintiammation have oieariy diminished, and oral hygiene is visiblyimproved

the use of toothpastes. Similar reductions in bleeding(22.6f'/o for the salt-containing toothpaste and 26,80/0for the conventiona! toothpaste) and plaque accumu-lation (13,60/b and llö^/o, respectively) were found inthe present study (Figs 6a and 6b),

Dentifrices contain various chetnical additives thatpromote them from a cosmetic tool to a means of pro-phylaxis and therapy. To guarantee maximum effi-ciency, these chemical ingredients should not haveconflicting actions.^ Addy et aP' found, for example,that detergents in toothpastes may diminish the wel!-lmown antimicrobial effect of chiorhexidine.

Because there appears to be a market for alterna-tive products in daily home plaque control, and therealso seems to be a demand for natural products, thepresent study tested products made of natural salts,which have been claimed to have anti-inflammatoryeffects, Gleissner et aP" used these natural salts in astudy on mouthrinses and was able to demonstratethat the regular use of salt solutions results in a reduc-tion of plaque accumulation and bleeding values inpatients with gingivitis.

The present study compared the salt-containingdentifrices to a conventional toothpaste lacking anyparticular antiplaque agents. The examination of aheterogenous patient group, as regards age and socialstatus, ensured realistic testing conditions. The use ofa control toothpaste containing chiorhexidine did notseem useful, because of chlorhexidlne's reduced effec-tiveness in toothpastes, A comparison with triclosanwas not performed because Moran et al" have alreadyshown similar effects of triclosan and fluoride-con-taining dentifrices.

The present study demonstrated that dentifricescontaining various chemical agents are appropriatesupplements to normal daily oral hygiene measures,especially for patients with periodontal diseases. Theingredients of the toothpaste are less important,because conventional toothpaste, which contains noparticular antiplaque agents, and the salt-containingdentifrices reduced plaque accumulation and gingi-val bleeding by a similar amount. This is in accor-dance with observations by Moran et a l " andMullally et al." who were unable to demonstrate sig-nificant differences between toothpastes containingactive agents and conventional fluoride-containingdentifrices.

It seems possible that the positive effect was duenot only to the ingredients of the products testedbut also to the test situation of the probands: Severalstudies have shown that the motivation of patientsduring clinical trials is high (Hawthorne effect) andmight even be amplified by oral hygiene instructions atthe beginning of the study or by the regular distribu-tion of new toothbrushes. Furthermore, Jeffcoat ^ sug-gested that the Hawthorne effect might contributernore to the positive results of clinical trials than thetherapeutic effect of the plaque-inhibiting agents.

Another factor that appears to have influenced theresults of the present study is the taste of the majoringredient. The poor ratings for the salt-containingproducts and the weaker results during the last 4weeks of the trial in both groups may have beencaused by a decline of oral hygiene measures in thisperiod of the trial, when no control examinationswere scheduled.

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This last possibility emphasizes one problem ofstudies involving oral hygiene measures at home: thelack of patient control by the examiner. Other factorsinfluencing the resuits of such studies include the timespan in which the toothpaste covers the tooth and theindividual's oral hygiene behavior. The margin of errorin measurements could be diminished by examining alarge nutnber of probands, and the oral hygiene be-havior might be standardized by instruction in brush-ing technique and oral hygiene at the beginning of thestudy period. However, the undeterminable variable ofthe mecbanical cleaning effect of the toothbrush, thelack of control of the probands. and the parallel studydesign may have contributed to the minimal effectsobser\'ed in this study. These well-known deficits ofhome oral hygiene studies cannot be compensated forby enlarging the number of probands.'•'

Because the effective exposure of the teeth to thetoothpaste is rather brief and dependent on the mixingprocess \v\lh saliva, the salt concentrations selected forthe toothpaste (lO -'o) and the gel (S /o) were relativelyhigh. A study by Gleissner et aP" showed a significantreduction of gingival bleeding when subjects used amouthrinse containing Po Emser Salt. A mouthrinsemade of 3''/b Emser Salt achieved an even higherplaque reduction.

The present study demonstrated no clear differencesamong the effects of the 3 dentifrices. Plaquereduction and the reduction of gingival bleedingachieved by means of the salt-containing productswere not significantly better than the results achievedwith the conventional dentifrice. The use of a crossoverstudy design might provide more significant results.Chilton and Fleiss" recommended a study period of atleast 6 months for examinations of plaque or gingivitis.This is all the more necessary to observe and classifythe patients' oral hygiene behavior patterns.

The gingival index was selected for evaluation ofgingival health since Hirt and Mühlemann^*" hadalready demonstrated the inadequacy of visual exami-nation alone in the evaluation of gingival disease.However, it is well documented that this index has itsweaknesses in the lower rating scale.-^

Regarding the patients' compliance, it is difficult togo beyond supposition. The patients returned onlysmall amounts of dentifrices with the tubes, and theyattended their appointments reliably. However, a bet-ter balancing of the proband groups, a shorter timespan between the recall examinations, the use of apatient diary, and more intensive oral hygiene instruc-tions might have achieved better, more statisticallysignificant results.

Overall, it can be said that the results are in agree-ment with those in most studies of the reduction ofplaque and gingival bleeding by the use of toothpastes:

After the initial prophylaxis, a Havi'thorne effect canbe observed, leading to an improvement in theprobands' oral hygiene behavior. This tTiost probablyobscures the effects of the medical agcnt. ^

CONCLUSION

1. The results of tbis study showed that the salt-con-taining dental products as well as a conventionaltoothpaste are appropriate means of at-homeplaque control and gingivitis prophyiaxis.

2. The contents of the dentifrices are secondaryand less important than is the regularity of tooth-brushing.

3. Patients with periodontal problems, especially withgingivitis, should be made aware that the composi-tion of their dentifrice is no substitute for the me-chanical cleansing of the teeth and that the denti-frice achieves its best results in combination witbregular brushing.

4. Dental products made of natural ingredients havepositive effects on gingival health that are compara-ble to those of dentifrices containing chemicalagents and thus provide an appropriate alternativeto conventional dentifrices.

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