Total Clinical 22

8/12/2019 Total Clinical 22

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Comparison of a Dentifrice Containing 0.243 Sodium Fluoride,0.3 Triclosan, and 2.0 Copolymer in a Silica Base, and a DentifriceContaining 0.243%Sodium Fluoride in a Silica Base: A Three-YearClinical Trial of Root Caries and Dental Crowns Among Adults

Yuval Vend, DMD , MPH Avi Uni, D M 4 MPH Jonathan Mann, DMD, MScHebrpw Unlversl y-IHadassab School Dental MedicheJ e d e m , Israel

WIlHam DeVWo, DMD Bernal Stewart,MSc Yun PoZhang, PbD Laura GardaColgate-Palmollve ecbnodogyCenter

Piscataway, New Jerseg USAAl%tract

Obj- Colgatea otalmoothpaste has been demonstrated to be highly effective in plaque and gingivitis control. The effect oftriclosan on mot caries and on the survival of dental crowns (fixed kntal prosthetic treatment) has not een evaluated. Inorder toexamine these importantvariables, a randomizedconmlled clinical trial was conducted comparingColgateTaal toothpalc withtriclosan,and m dentical fluoride toothpaste without triclosan.Methods: Adult subjects w e n mdomly assigned to a test p u p usingColgakTotal plus Whitening toothpste with triclosan, anda control groupusing Colgatesodium fluoride toothpaste wirhout triclosan.By the end of the study, following threeyears of productuse an evaluationwas performed to compare baseline data to the threeyeardata for tcaries and dental crown survival.Clinicalmot caries was eveluated by the Katz RCI- R m aries Index. Within-treatment analysis for each dentifrice was conducted usinga paired [-test. Benvetn-tmfment annlysis was pwformcd using Analysis of Covariance (ANCOVA). For fixed dental prosthetictreatment evaluation, dental crowns were dichdomized for success and failure at the end of the study. Within-treatment analysisfor each dentifrice was conducted using a paired t-test. Between-treatment analysis was performed using the Bonfemni tcst.R e u k One-Ihousand, three-hundred, and ifty-sewnsubjects 1.357) completed the study. Regardingr caries. at m i n a t i o nof the study the Cdgate Total group presented a mean score of 1.14 + 1.75 and a +5.6 change from baseline, while h e sodiumfluoride toothpastepresented a mean of 1.25 1.88and a 4 3 . 2 %change from baseline @


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Vd.XX, N a

oothbrushing is the easiest and mast commonprwedure inrht promotion of o d ygiene. Dentifrigesarc themost b f i c i a ldmtalproducts forrorrtirrcly adminiskringeB8aive tbcmpeuticand cosmetic agents into the mouth. The most cornmanly usedlberaptutic agent added to dentifrices s fluoride, which aids inthe controlof caries. Most ntriguingis the concept ofchemicalpIaquc cxmtrol, inwhich chemicalcompoundsare usedasa su ppkment, butnot a subsfitute for bmsbing.Wws substanceshavebeen suggestedas additivesto loath-pasta in arda to prevent t m h decay gingivitis, periodon-titis.' Trkbsanisabroabspecznrm antEbecteriaI a*, w d urhm 30years in aonsumerproducts, @mMy daodorantsand soaps. It has also hown to be a useful m t i magent in ealth care pmducts, such as dentifrices andinmthhe.5 linical es inhumanshave s h m t tolx safeforw causingnosystemicor l a d sidaeffects and no ne@ivedTectson heoral microbial bco108y. Furthcsmore, theadditimo f r r i d o s a n t u d ~ p r o d u c t s h a s b e M l ~ t o F B d u c e ~ t a lphque, gingivitis, and calculus. In 1997, the Food and DrugAdministration of the United States (FDA) approved ColgatemT& mtbpste [ColgaePdmlive Co., ew York,W SA),which contains tticlosan,copolymer,and fluoride,asa dmtifrbro kip p e n t gingivitis, plaque, and caries. his technologywas evaluated in many human clinical trials using a dentifricecontaining 0.3 riclosan, 2.0 PVMlMA copolymer, and0.243 sodium fluoride in a silica base. and has beeni d olxm m ffectiven d u c h g dental plaque, gingivitis, caJcQus.and coronal caries tban regular fluoride h t i f r i e a M lhc cur-rent r n ~ ~ow includes clinically p r o m , American DEntal Association- dentifrices containing0.243% mfluoride in a silica base, both with and without the i d u s i o a oftriclclsan and copolymer.Thwgh Colgate Total toothpastehasbew demonstrsued to bchighlyeffectiveinplaque and ghgivitiscontrol. no study has yetevaluatedtheeffectof triclosan onmot caries.Thisisespeciallyimpwtam Boday as older adultsmaintain their teeth for longerpariotis. Additionally, nostudy hasevaluated the of h eg-ular use of CoQate htd toothpaste on the suwival of dentalmwm {fixed dental pttletic treatment).inonkr to evaluate these pruamcttrs, a d o m i d ontrolledclinical rial was conc4uctsd comparingColgate Total twthpastccontaining triclosltn.and an dentical sodium fluoride tmthp.tewilhout t r i c h n .

Materialsand Methodst u d y ~ o lThe study employed a double-blind. two-tmtmcnt. parallelgroup&sigill.Adult nlales und females ov r 5 yearsofage. re-siding thmgkut Israel in 5 communityMlernents (kibbutzim).participated in the study. Subjects who met the inclusioncriteriaand had at Iwst one intac~ rown (fixed dental prosthetic treat-ment) were asked to sign an informed consent farm (Helsinki

if tbey participated in any other clinical study during the t hmwths priortotk basehe aamhtion or ifthty m t s d m yw d t io a which, in theopinionofthe nv+=ti atw,would impedetheir ability to mipateQualifying subjects were m M y wiped to the two mu-meat group, which w r matchad far age andg e r . . Ottemment p u p was assigned to ColgatcmTotala plus Wtaningmtbpask, which contains 0243 d u r n fluwide, 0.3 tridosan,and 2.0 copolymer in a silic base (Colgate-Palm01iveCo., New Yo&. NY SA). The Mher tmment p u p was as-signed tu Colgate fluoride -te which contains0.243sDdiumflu in a silica base (withwt t r i c l m aod copolym~],

Theh t i f i m s w m rovided o the smdy subjectsfour t i m iper year alongwith fouradult-sized, soft-bristled t o o t h b ~ .Dentifriot tubes wsrr covered with white wewrap to mask theidentityof the p d hen new tubes of the ddf r iccdelivered, subjects returned their previous tubes so that compli-m could bemonitored.Aftef trsatrneatassignment, study par-ticipants were irrsrm twl o brush their teeth at home with theirassigned dantifrice for at l a e minutetwicedaily. Subjfctswere not resdcted from seeking dental treatment,At baseline (U303-2004), all subjectsmidan evaluatioaofroot caries. missing teeth illings,mov&leandh td prosh nd implants. Post-bliw exeminationsw m erf&a f t t r o n e d h v o p r s o f ~ ~ t u a f o r ~ o f c o l w r a lcaries, and miwing and filled teeth. For root caries and d a dcrowns, awmpisunwas performed Mwcen b u i n e dam andthree years (by the end of the study, 2 ~ 2 0 0 7 ) .A subset of 20 subjectswas then to conduct an inter- andinmexaminer calibration. The 20 subjects were examhid bybotb potentialcxaminws (I.M.and Y-V.), andwlt producbda kappa of 0.87, In d i t i o n , an i n m u m i n e r calibrationwasconducted by the two examiners n the followingdays, and xp.sulw PfOdwdd a kappa of 0.88. Finally, om examiner (Y.V.1p e r f o d l l the examinations. An annual tm of inw andintra-caliht ion was epeatedin order o tnsm a back-up, fullycalibmad examiner j f necessary,Wt&MAnalyshCliniclllioor caries was evaluatedbytkKak XI -RootThe baseline RCImeansand standard &viahas of thetwo dentifrica w m nalyzed accordingto independoat t-tests.The within-matment analysis for tach dentif ie was perfusing e paired t-t. Thck w ~ m t m e n tdjustedmean analy-siswas p f o d sing Analysis ofCovariaoce (ANGOVA).M t a l crowns (intact fixed dental ptaotbetlc tmmmt3 w erecorded at -line, Evaluation of the survival of t b m saawcrowns waq dichotomized forsuccess nd failurtati end of h estudy (newlyplaced crowns duting the courseof the studyWEnot renlrdcd). Success was operatiandly defined as au inlac1crown at the end of the study. Replaced crowns on m u ra l tcand cxmction o f crowned teeth during the three-year Ma8of


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The Juurnal C h d d Dentistry

The between-rFeaunent mcan analysis was performed with ad-justment for multiple comparisons using the Sonfemni test.The staristicai processing was pformed by SPSS 15.0 soft-ware. A statistical test was consid ed significantwhen p


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work as a resuIt of high prevalence of dental caries over theyears, Ro o t caries and dental prosthetic treatment are more typical inan e l h l y population,and these may c a w a health problem and a financial burden. ".' I-Dentalcarisa d modontal diseasescan bemtmlIed by o ptima1 oral hygiene habits involving daily taoth brushing with adentifrice. Fluoride, the most commonly used therapeutic agentadded to d e n t j f d s , bas a dramatic effect m he wnrrol of den-

tal caries. Plaque control is beneficial for ae control of caries,as well u he control of periodontal diseases,'4 The nability ofm y nd~vidudso remove heir awn ental plaqueresults fmminsuficient knowledge, poor mechanical dexteriricy, or lack ofopportunity or motivation. The idea of a chemical m e t W ofplaque removaI,vk dentifriceth tcan supplement mechanicalplaque removal, is therefore highly attractive.Colgate Tota1 toothpaste was originally designed and opti-mized for maximal delivery and retention of triclosan on oral

surfaces Thiswas achieved by utilizing a special copulymer 10increase he suWtivily of triclosau to both the hard and sofitissues of the oral cavity. f i s echaology reduces t h e loss oftriclwan from oral surfaces which nomally would occur duringsalivary flow. Many human clinical miab using Colgate Totaltoothpaste have demonstrafedstatistically significant reducrionsin dentalplaque, gingivitis, cdcuhs andcoronal caries as cornpared to regular fluoride dentifrice^ ^^ The aim of the presentclinical study was to compare a dentifrice containing fluoride(NaF) lo a dentifrice containing fluoride Nan,triclosan, andP V W h l 4 copolymer, and to m p a t i v e l y evaluate theireffecton oat caries and the continued survival of dental crowns.A camparimn W e e n he two study groups revealed a statistically s i g n i f i a t~~e fwm wries md dental crown fail-ure scores both fawring the triclman toohpaste (Colgate Total).

The mean three-year increment of mt caries in the groupusing the sodium fluoride tmthpastewas almost six-fold higherthan at of he ColgateTotal toothpaste group (Table 111; 0.38vs. 0.07,

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Total Clinical 22