J Clin Periodontol 2002: 29: 1086–1091 Copyright C Blackwell Munksgaard 2002Printed in Denmark . All rights reserved

0303-6979

Michael Rosin1,6, Axel Kramer2,The effect of a SCN–/H2O2 Detlef Bradtke3, Gerrit Richter4 andThomas Kocher5

1Department of Operative Dentistry,toothpaste compared to a Periodontology, and Paediatric Dentistry,2Institute of Hygiene and EnvironmentalMedicine, 3Private Practice, Greifswald,4Private Practice, Seebad Ahlbeck, 5Unit ofcommercially available triclosan- Periodontology, University of Greifswald,Germany, 6Department of Periodontology,Eastman Dental Institute, University CollegeLondon, London, UKcontaining toothpaste on oral

hygiene and gingival health –a 6-month home-use studyRosin M, Kramer A, Bradtke D, Richter G, Kocher T: The effect of a SCN–/H2O2

toothpaste compared to a commercially available triclosan-containing toothpasteon oral hygiene and gingival health – a 6-month home-use study. J Clin Periodontol2002; 29: 1086–1091. C Blackwell Munksgaard 2002.

AbstractObjectives: The aim of the study was to compare the gingival health benefits ofa thiocyanate/carbamide peroxide toothpaste to that of a triclosan toothpaste inhome use.Materials and methods: The study was a two-centre, randomised, double-blind,parallel-group clinical trial, and consisted of a 2-week pre-experimental phase,followed by an experimental period of 6months. A total of 140 healthy male andfemale volunteers (70 per group) who had at least 20 natural teeth with noprobing depths greater than 5mm and a mean gingival index (GI) of 1 or moreat screening were admitted to the study. The two products were the test tooth-paste (RCP) containing 0.5% SCN– (rhodanide), carbamide peroxide (equivalent0.1% H2O2), and 1450p.p.m. fluoride, and a control toothpaste (Colgate TotalA)containing 0.3% triclosan, 2.0% polyvinyl methyl ether maleic acid (PVM/MA),and 1450p.p.m. fluoride (Triclosan). In the pre-experimental phase, all subjectsused a fluoride toothpaste. Plaque (Turesky et al. 1970) and gingivitis (Löe &Silness 1963) were scored prior to beginning the pre-experimental phase, at base-line, and after 6weeks and 3 and 6months.Results: In both the RCP and the Triclosan group, gingival health improvedsignificantly between baseline and the following examinations. Plaque scores de-creased significantly between baseline and 6months in both groups. There were,however, no significant differences between the groups for either gingival index orplaque index.Conclusion: To conclude, this study seems to verify that in normal home use, a

Key words: thiocyanate; carbamide peroxide;toothpaste containing a combination of thiocyanate and carbamide peroxide istoothpaste; gingivitisas effective in reducing gingival inflammation and supragingival plaque forma-

tion as a benchmark control product. Accepted for publication 2 January 2002

SCN–/H2O2 peroxide toothpaste 1087

It is no longer accepted that gingival in-flammation, if present over a suffi-ciently long period of time, inevitablyleads to periodontitis (Attström & vander Velden 1994). However, currentopinion supports the concept thatchronic periodontitis is always precededby chronic gingivitis (Attström & vander Velden 1994, Löe et al. 1986, Sheih-am 1997). Unfortunately, no reliable,cost-effective tests are currently avail-able to identify subjects who are at riskfor the occurrence of periodontalbreakdown (Attström & van der Velden1994, Jeffcoat 1994). Therefore, preven-tive and therapeutic programmes forperiodontal disease are directed at largeproportions of the community. This ap-proach supports the need to search fororal hygiene products that reducechronic gingivitis in the population(Jeffcoat 1994, Robinson 1995).

Recently, we screened different testdentifrices consisting of a gel base with-out any detergents or abrasives but con-taining various thiocyanate (SCN–)/car-bamide peroxide (CP) combinations fortheir oral health benefits (Rosin et al.2001). In this 10-week clinical trial,0.5% SCN– in combination with CPequivalent to 0.1% hydrogen peroxide(H2O2) significantly reduced plaque andgingivitis as compared to baselinevalues and a placebo, respectively(Rosin et al. 2001). The main idea be-hind this active ingredient concept wasto apply SCN– at concentrations far inexcess of that in normal saliva. In themammalian organism, SCN– acts as aubiquitous vitaminoid (for review, seeKramer & Böhland 1996). SCN– pro-motes unspecific and specific resistancemechanisms (Apitzsch et al. 1985,Jülich et al. 1973, Jülich et al. 1997,Pollock et al. 1983) and regenerativeprocesses (Koch 1989, Kramer 1985)and has important protective functionsunder toxic and mutagenic influences,in processes of ageing, and in inflam-mations (, Kramer & Weuffen 1996Na-gasawa et al. 1980, Whitehouse &Rainsford 1983). The application ofSCN– was thus expected to exert nu-merous effects with benefits for gingivalhealth and was only partly aimed at theknown effects (Tenovuo & Pruitt 1984)in the salivary peroxidase system. Like-wise, the CP component not only sup-ports the peroxidase system by promot-ing the bioavailability of H2O2 (Pruittet al. 1982), but the urea which is gener-ated also facilitates SCN– penetrationinto the oral mucosa (Wohlrab 1989),

thus supporting the efficacy of SCN– inthe gingival tissues.

As a next step in the evaluation of theSCN–/CP active-ingredient concept, itappears to be reasonable to include it ina normal toothpaste formulation andto compare this product to a bench-mark control (Addy et al. 1992). Theaim of the study was to compare anewly formulated toothpaste contain-ing 0.5% SCN– and CP equivalent to0.1% H2O2 under home-use conditionsto a commercially available productwith proven oral hygiene and gingivalhealth benefits.

Materials and methodsSubjects

The study was performed in two gen-eral dental practices in the region ofGreifswald (Germany). In each prac-tice, 70 subjects were recruited. In orderto participate in the study, the subjectshad to meet the following criteria:

O age between 18 and 45yearsO a minimum of 20 uncrowned perma-

nent natural teethO no intraoral appliances or partial

denturesO a mean gingivitis score (GI) at

screening of 1.0 according to theTalbot et al. (1977) modification ofthe Löe & Silness (1963) gingivalindex

O no probing depths 5mm.

All subjects had a negative history ofantibiotic treatment 3months prior tothe examination. None of the subjectshad a systemic illness known to affectoral health, and female subjects wereneither pregnant nor nursing. Ethicalapproval for the study was obtainedfrom the Ethics Committee of theMedical School of Greifswald Univer-sity. All subjects gave signed and wit-nessed consent to participate after re-ceiving a thorough verbal and writtenexplanation as to the nature and con-duct of the study.

Study design

The study was a double-blind, parallel-group comparison of two toothpastes(described below) and consisted of a 2-week pre-experimental phase, followedby an experimental period of 6months(Fig.1). Subjects were assigned to oneof the two groups according to a ran-

domised schedule. Allocation, produc-tion and/or packaging of the test prod-ucts was done by the manufacturer(Henkel KgaA, Dusseldorf, Germany),which also kept sealed code breakersfor each subject. During the pre-experi-mental phase, about the details ofwhich neither the two investigators northe subjects were informed, bothgroups used the same fluoride tooth-paste (described below) (Fig.1). At thestart of the pre-experimental phase, thetoothpastes and toothbrushes (Oral-BA 35, Oral-B laboratories, Frankfurt,Germany) were distributed to the sub-jects. They were asked to brush theirteeth two times per day, in the morningand in the evening, and to refrain fromusing any other oral hygiene productsfor the duration of the trial. No attemptwas made to change the subjects’ brush-ing technique.

Following the pre-experimentalperiod, the subjects attended the base-line examination, where they returnedthe used toothpaste tubes. They werethen provided with their allocatedtoothpastes and new toothbrushes, andbegan the experimental period (Fig.1).In an attempt to monitor compliance,return of used products was also re-quested at the end of the trial.

Test toothpastes

A toothpaste (RCP) containing SCN–

(rhodanide) and carbamide peroxide(CP) was tested against a commerciallyavailable triclosan-containing tooth-paste (Colgate TotalA, Colgate Palmol-ive, Hamburg, Germany), referred to asTriclosan. During the pre-experimentalphase, both test groups used a fluoridetoothpaste (Fluoride) with the sameformulation as RCP, but without theSCN–/CP combination. The concen-trations of the active ingredients were:

O Group A (RCP): Fluoride (NaFequivalent 1450p.p.m. F–), 0.5%SCN–, carbamide peroxide (equiva-lent 0.1% H2O2)

O Group B (Triclosan): Fluoride (NaFequivalent 1450p.p.m. F–), 0.3%triclosan, 2% copolymer (PVM/MA)

O Fluoride: Fluoride (NaF equivalent1450p.p.m. F–)

For reasons of product stability, theSCN– and H2O2 components of theRCP toothpaste had to be separated. Inorder to avoid technically difficult pro-cedures and extravagant double-

1088 Rosin et al.

chamber tubes, the test toothpastegiven to participants consisted of twotubes. To ensure that the double-blindnature of the study was upheld, thefluoride and triclosan toothpastes werealso distributed in two tubes. Each sub-ject thus received two plain white tubes,one with a white and one with a greenlabel containing a white and a greenpaste, respectively. The labels displayedthe subject number, the name of thestudy and the responsible institution,and instructions to use the contentsonly in conjunction with the corre-sponding tube. The subjects were in-structed to apply equal amounts (1.5cm) from each tube onto the tooth-brush so that mixing of the two compo-nents of the respective product tookplace during toothbrushing. Instruc-tions on how to apply the toothpasteswere reinforced at both baseline and the3-month visit.

Clinical examination

In each of the two practices, screeningand patient selection were carried out bya single investigator who also performedall clinical examinations of the partici-pating subjects. At the screening exami-nation (Fig.1), a medical history was ob-tained, and the GI and pocket depthswere recorded using CP-15UNC probes(HU-Friedy Europe, Leimen, Ger-many). All teeth, except 3rd molars, wereexamined at six sites: distobuccal, buc-cal, mesiobuccal, distolingual, lingual,mesiolingual. At the start of the pre-ex-perimental phase (ª2weeks) and of theexperimental period (baseline), theplaque index (QHI) and the GI were as-sessed (Fig.1). Plaque was disclosed witha disclosing solution (MIRA-2-TON,Hager & Werken, Duisburg, Germany)and scored using the Turesky et al.(1970) modification of the Quigley &

Fig. 1. Outline of the clinical trial.

Hein (1962) plaque index. The scoreswere taken at six surfaces per tooth: me-sio-, mid-, distobuccal, mesio-, mid- anddistolingual tooth surfaces, correspond-ing to the sites for GI scoring. Safety wasassessed via an oral soft tissue examina-tion performed at ª2weeks, at baselineand at each recall visit. Recall visits wereat 6 weeks and 3 and 6 months afterbaseline, when plaque and gingivitiswere recorded according to the criteriaused at baseline (Fig.1).

Reproducibility of clinical examinations

The two clinical investigators (DB andGR) were given intensive clinical train-ing to achieve high reproducibility ofthe QHI and GI scorings. Prior to thestudy, five calibrating sessions were per-formed in which the two investigatorswere calibrated against a very experi-enced investigator (TK). Each time, twopatients were examined, during which afourth clinician (MR) performed theexaminations while the three investi-gators watched and scored indepen-dently. Over the duration of the entirestudy, additional sessions were carriedout at 4-week intervals to check andmaintain consistency in the responses ofthe two investigators. In those calibrat-ing sessions, the examination of pa-tients was performed by an experiencedclinician (MR) while the QHI and GIwere scored independently by the twoinvestigators. Ten sessions, examiningtwo patients each time, were performedbetween June 1999 and March 2000.

Statistical analysis

Statistical analysis was managed by anexternal statistician group. Interexam-iner reliability was determined by calcu-lating kappa coefficients. Analyses ofthe study data were performed using

SPSS version 10.0.5. Repeated measuresANOVA was used to determine whetherthere was any overall treatment effectand whether there was any significantreduction from baseline over time.Drop-outs were excluded from theanalysis. Therefore, sensitivity analyseswere conducted to ensure the consist-ency of the results.

ResultsInterexaminer reliability/compliance

In the calibration session before thestart of the pre-experimental phase, aninterexaminer reliability of k0.78 andk0.73 was achieved for the QHI andGI, respectively. The respective valuesfor the session during the course of thestudy were between k0.74 and k0.81 for the QHI and between k0.69and k0.77 for the GI.

A total of 140 subjects, 76 femalesand 64 males, were enrolled in the study(mean age 36.5years). There were 40smokers and 100 non-smokers. Enrol-ment commenced in May 1999 and wascompleted in October 1999. There wasa total of four withdrawals from thetrial (one in the pre-experimental phaseand three in experimental period), noneof which were deemed product related.

Pre-experimental phase

The effect of the pre-experimentalphase on the GI and QHI is depicted inFig.2. The comparison of the respectivebox plots at the beginning of the pre-experimental phase and at baselineshows that the use of the same fluoridetoothpaste in both groups led to a nar-rowing of the interquartile range for theGI and to the minima and maxima ap-proaching the median, while the scat-tering of QHI values tended to increase(Fig.2).

Gingivitis

In the experimental period, a statisti-cally significant decrease over time inGI scores were found in both the RCPand the Triclosan group (P0.001).This reduction in gingival inflammationwas relatively pronounced betweenbaseline and 6 weeks, and then easedinto a more moderate but constant re-duction between 6 weeks and 6 months(Fig.3). There was no evidence of over-all statistically significant treatment dif-ferences at either 6 weeks or 3 and

SCN–/H2O2 peroxide toothpaste 1089

Fig. 2. Effect of the pre-experimental phase on the Gingival Index and Plaque Index of bothtest groups.

months with PΩ0.067, PΩ0.614 andPΩ0.745, respectively.

Dental plaque

The mean QHI scores at the various ex-aminations during the experimentalperiod are shown in Fig. 4. No changesin the QHI scores could be observed forthe RCP group between baseline and 6weeks or for the Triclosan group be-

Fig. 3. Gingival index (means and standarddeviations) in the experimental period.

Fig. 4. Plaque Index (means and standarddeviations) in the experimental period.

tween baseline and 3 months (Fig.4).However, for both the RCP and theTriclosan group, a statistically signifi-cant reduction in plaque scores wasfound between baseline and the 6-month examination (P0.001). Therewas, however, no evidence of statisti-cally significant differences between thetwo groups at either 6 weeks or 3 and6 months with PΩ0.428, PΩ0.054 andPΩ0.144, respectively.

Discussion

Recently, a SCN–/carbamide peroxideformulation (RCP) has shown promis-ing results in a pilot study (Rosin et al.2001). Interestingly, the positive effectsof RCP with respect to promotion ofgingival health appear to be mediatedboth by plaque inhibition and by amodulation of the tissue responses(Rosin et al. 2001). The present studywas conceived to evaluate the gingivalhealth effects of the active ingredientRCP when integrated in a normaltoothpaste formulation. To maintain anappropriate control in this trial, a lead-ing commercially available toothpaste,Colgate TotalA, often termed bench-mark control (Addy et al. 1992), wasutilised for comparison. This tooth-paste contains 0.3% triclosan in combi-nation with 2% copolymer (polyvinylmethyl ether maleic acid – PVM/MA)and showed significant oral hygiene andgingival health benefits in a number ofstudies (Bolden et al. 1992, Garcia-Go-

doy et al. 1990, Kocher et al. 2000,Ramberg et al. 1995, Svatun et al.1993). Recently, in a study reported byRosling et al. (1997), Colgate TotalA

was found to reduce the frequency ofdeep periodontal pockets and the num-ber of sites that exhibited additionalprobing attachment and bone loss. Itwas concluded therefore that the dailyuse of this toothpaste may retard pro-gression of periodontitis (Rosling et al.1997).

The most interesting finding of thepresent study was the comparable andsignificant reduction in gingivitis forboth RCP and Triclosan occurring inthe absence of a corresponding plaquereduction. Throughout the whole ob-servation period, the GI in both groupsdecreased continually, whereas the QHIvirtually did not change between base-line and 6 weeks in the RCP group andbetween baseline and 3 months in theTriclosan group (Figs. 3 and 4). Thisseems to be an indication that bothRCP and triclosan exert a direct posi-tive influence on gingival health, whichdoes not occur indirectly via the se-quence plaque reduction/decreased bac-terial load/gradual lessening of the in-flammation. Our results thereforewould support findings from other clin-ical studies on triclosan which reporteda clinically relevant improvement in gin-gival health while the plaque-reducingeffect was modest or even absent(Kocher et al. 2000, Ramberg et al.1995, Svatun et al. 1993). Indeed, localapplication of triclosan has been re-ported to have an anti-inflammatory ef-fect on oral mucosa (Waaler et al. 1993)and dermal inflammatory lesions(Barkvoll & Rölla 1994, Kjaerheimet al. 1995). Recent studies suggest thatthe anti-inflammatory effect of triclos-an is partly due to its inhibitory effecton the formation of important me-diators of inflammation such as in-terleukin-1b, prostaglandin E2 and in-terferon-g (Gaffar et al. 1995, Modeeret al. 1996, Mustafa et al. 1998, 2000).

A significant anti-inflammatory effectfor RCP has already been observed ina previous clinical study (same dosage)(Rosin et al. 2001). Although the speci-fic mechanisms of the antigingivitis ef-fect of RCP have not yet been investi-gated, the known protective and pro-re-generative effects of SCN– (Koch 1989,Kramer et al. 1990, Kramer & Weuffen1996, Nagasawa et al. 1980,Whitehouse & Rainsford 1983) and theprotective function of SCN– against

1090 Rosin et al.

toxins and oxygen radicals (for reviewsee Kramer & Böhland 1996) present anumber of potential pathways for a re-duction in gingivitis aside from aplaque-inhibitory effect.

When substances known to have littleplaque inhibitory effect are beingtested, the evaluation of the antiplaqueeffectiveness in a toothbrushing study isin general difficult. In a toothbrushingstudy, the effect of the active ingredientis always overshadowed by the effect ofmechanical cleaning, which may maskthe superiority of a particular productover the controls. Furthermore, it is un-likely that a small plaque inhibitory ef-fect can outperform the intensified ef-forts in toothcleaning of subjects know-ingly participating in a study whereplaque is scored by a member of thedental team. Indeed, the superiorplaque inhibitory activity of triclosancompared to a placebo, although sig-nificantly established in a plaque re-growth study (Binney et al. 1995), hasnot been demonstrable when triclosanwas tested in home-use toothbrushingstudies (Binney et al. 1996, Owens et al.1997). This illustrates the limited valueof plaque records in brushing studies, atleast when agents of known low plaqueinhibitory effect are being tested. How-ever, the plaque scores of the subjectsmay be of importance, as in the presentstudy, to interpret and explain the gin-givitis data; however, they should be re-garded as a covariable rather than as aprimary parameter.

The results of the present study showthat a thiocyanate/carbamide peroxidetoothpaste (RCP) was as effective in thecontrol of gingivitis as the commer-cially available benchmark controltoothpaste (Triclosan). It was con-cluded therefore that the RCP productoffers an efficacious alternative to con-ventional toothpaste formulations.

Acknowledgements

The authors wish to thank Prof. Dr DrH. Toutenburg, Dr S. Toutenburg andDr Ch. Kastner (University of Munich)for the statistical analysis, and HenkelKgaA for providing the test dentifricesand support of the study.

Zusammenfassung

Vergleich zwischen der Wirkung einer SCNª/H2O2-Zahnpasta und einer kommerziell er-hältlichen Triclosan-haltigen Zahnpasta aufMundhygiene und Entzündungsfreiheit der

Gingiva – eine 6-monatige Studie über diehäuslichen AnwendungZiele: Das Ziel der Studie war es, die Vorteilefür die Gesundheit der Gingiva bei häusli-cher Anwendung einer Thiocyanat/Carba-mid-Peroxid-Zahnpasta mit denen einer Tric-losan-Zahnpasta zu vergleichen.Material und Methoden: Die Studie wareine, an zwei Zentren durchgeführte rando-misierte Doppel-Blind-Studie mit Parallel-Gruppen-Design. Sie bestand aus einer 2-wö-chigen prä-experimentellen Phase auf welcheeine experimentelle Periode von 6 Monatenfolgte. Ingesamt wurden 140 gesunde männli-che und weibliche Freiwillige (70 pro Grup-pe) mit wenigstens 20 natürlichen Zähnenund keiner Sondierungstiefe über 5 mm so-wie mit einem Gingiva-Index (GI) bei derEingangsuntersuchung von 1 oder höher indie Studie aufgenommen. Die zwei Produktewaren die Test-Zahnpasta (RCP), welche0,5% SCNª (Rhodanid), Carbamid-Peroxid(äquivalent 0,1% H2O2) und 1450 p.p.m.Fluorid enthielt sowie eine Kontroll-Zahnpa-sta (Colgate Total&A), welche 0,3% Triclo-san, 2,0% Polyvinyl-Methylether-Maleinsäu-re (PVM/MA) und 1450 p.p.m. Fluorid (Tric-losan) enthielt. In der prä-experimentellenPhase verwendeten alle Teilnehmer eineFluorid-Zahnpasta. Vor dem Beginn der prä-experimentellen Phase, bei der Ausgangsun-tersuchung und nach 6 Wochen sowie 3 und 6Monaten wurden Plaque (Turesky et al. 1970)und Gingivitis (Löe & Silness 1963) be-urteilt.Ergebnisse: Zwischen der Ausgangsuntersu-chung und den Folgeuntersuchungen verbes-serte sich sowohl in der RCP- als auch in derTriclosan-Gruppe die Gesundheit der Gingi-va signifikant. Zwischen der Ausgangsunter-suchung und der 6-Monatsuntersuchung ver-minderten sich die Plaquewerte in beidenGruppen signifikant. Bezüglich Gingiva-In-dex oder Plaque-Index gab es jedoch zwi-schen den Gruppen keine signifikanten Un-terschiede.Schlussfolgerung: Diese Studie scheint zu ver-ifizieren, dass die häusliche Anwendung einerZahnpasta, die eine Kombination aus Thio-cyanat und Carbamid-Peroxid enthält, dieEntzündung der Gingiva und die supragingi-vale Plaquebildung genauso effektiv redu-ziert, wie das Vergleichs-Kontrollprodukt.

Resume

Effet d‘un dentifrice SCNª/H2O2 compare aun dentirice contenant du triclosan vendu dansle commerce sur l‘hygiene buccale et la santegingivale. Une etude de l‘utilisation a domiciledurant six moisCette etude etait un essai clinique en groupeparallele, en double aveugle, randomise effec-tue dans deux centres et consistait en unephase pre-experimentale de deux semainessuivies par une periode experimentale de sixmois. Cent quarante hommes et femmes (70/groupe) qui avaient au minimum 20 dentsnaturelles avec aucune profondeur de poche5 mm et un indice gingival moyen (GI) de

un ou plus ont ete admis dans cette etude.Les deux produits etaient le dentifrice test(RCP) contenant 0,5% de SCNª (rhodani-de), du peroxyde carbamide (equivalent a 0,1H2O2) et 1450 ppm de fluorure, et un denti-frice controle (Colgate TotalA) contenant0,3% de triclosan, 2,0% de PVM/MA et 1450ppm de fluorure (Triclosan). Dans la phasepre-experimentale, tous les sujets ont utiliseun dentifrice avec fluorure. L‘indice de pla-que (Turesky et al. 1970) et de gingivite(Löe &Silness 1963) ont ete enregistres avantle debut de la phase pre-experimentale, audepart et six semaines, trois et six mois plustard. La sante gingivale s‘est amelioree dansles deux groupes entre l‘examen de depart etles examens suivants. Les scores de plaquedentaire ont diminue significativement entrele depart et six mois plus tard dans les deuxgroupes. Il n‘y avait par contre aucune diffe-rence significative entre les groupes que cesoit pour la plaque dentaire ou pour l‘indicegingival. L‘utilisation normale a domiciled‘un dentifrice contenant une association dethyocyanate et peroxide carbamide vendudans le commerce est donc un moyen efficacede reduire la plaque sus-gingivale et l‘in-flammation gingivale.

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Address:Priv.-Doz. Dr Michael RosinDepartment of Operative Dentistry,Periodontology and Paediatric DentistrySchool of DentistryUniversity of GreifswaldRotgerberstr. 8D 17489 GreifswaldGermanyPhone: π49 3834 867167Fax: π49 3834 867171e-mail: rosin/uni-greifswald.de