The effect of the dentifrice on gingivitis and dental plaque: A 6 week clinical study in India

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1 jiphd R AQ 0 0 The effect of the dentifrice on gingivitis nd dentl plque: A week clinicl study in Indi K. V. V. Prsd, I. Anupm, N. Ro, P. K. Sreenivsn, R. Subrmnym, R. D. Kulkrni Deprtment of Public Helth Dentistry, SDM College of Dentl Sciences nd Hospitl, Deprtment of Microbiology, SDM College of Medicl Sciences nd Hospitl, Bengluru, Krntk, Indi, Colgte Plmoliv Compnu, Pisctwy, New Jersey, USA Address for correspondence: Dr. K. V. V. Prsd, Deprtment of Public Helth Dentistry, SDM College of Dentl Sciences, Dhrwd 00, Krntk, Indi. E mil: kkrlp@hotmil.com Abstrct: Introduction: Dentifrices re commonly used for orl hygiene with some formulted with ntimicrobil gents to control plque. There is little informtion regrding the effects of dentifrices on controlling dentl plque nd gingivitis mongst Indin subjects. Objective: To evlute the efficcy of three commercilly vilble fluoride dentifrices on estblished gingivitis nd suprgingivl dentl plque fter week of product use. Mterils nd Methods: Adult subjects completing informed consent nd presenting Loe Silness gingivl index (GI) score.0 nd Quigley Hein, Turesky Modifiction, plque index (PI) score. completed week wshout period with commercil fluoride toothpste. They were instructed to refrin from ll other orl hygiene products (including mints, chewing gums, mouth rinses). Subjects returned to the clinicl fcility gin hving refrined from ll orl hygiene procedures for h nd from eting, drinking or smoking for h for bseline gingivitis nd plque exmintions. They were rndomly ssigned to one of three tretment groups ccording to bseline gingivl nd plque indices scores: () A dentifrice contining 0.% triclosn nd 00 ppm sodium (Colgte Supershkti Dentl Crem), () dentifrice contining 0.% zinc citrte, 0.% stnnous chloride nd 0.% sodium fluoride (Crest Pro Helth All Good Effects Toothpste), nd () dentifrice contining 00 ppm sodium (Colgte CIBACA Toothpste [negtive control]). After week use of their ssigned dentifrice, ll subjects were reclled for posttretment plque nd GI exmintions. Results: subjects completed the study. Bseline plque nd GI scores demonstrted no sttisticl differences between tretment groups (P > 0.0). Further, Chi squre nlysis demonstrted no significnt differences between tretment groups for subject ge or gender (P > 0.0). At the week exmintions, subjects in ll three dentifrice groups exhibited sttisticlly significnt reductions in GI scores (.%,.% nd.%, respectively) nd PI (.%,.% nd 0.%, respectively) scores from bseline (P < 0.0). The triclosn group exhibited sttisticlly significnt (P < 0.0) reductions in GI scores (.% nd.%, respectively) nd PI scores (.% nd.%, respectively) when compred to the zinc citrte/stnnous chloride dentifrice nd to the sodium dentifrice. Conclusion: The triclosn/sodium dentifrice (Colgte Supershkti Dentl Crem) demonstrted significntly less gingivitis nd greter reductions of suprgingivl dentl plque (P < 0.0) when compred to dentifrice contining zinc citrte/stnnous chloride/sodium fluoride (Crest Pro Helth All Good Effects Toothpste) nd to dentifrice contining sodium (Colgte CIBACA Toothpste). Key words: Dentifrice, gingivitis, plque, triclosn INTRODUCTION Periodontl disese hs been known to ffect mnkind since the beginning of recorded history, nd even tody remins n orl helth problem worldwide. It is condition wherein, inflmmtion nd infection destroy the supporting structures of the teeth, including the gingiv, the periodontl ligment nd the lveolr bone. Gingivitis, the mildest form of periodontl disese, is n inflmmtory process confined to the gingiv. It is cused by nonspecific, long term ccumultion of plque on the teeth nd is usully reversible. originl rticle Plque induced gingivitis is the most common form of periodontl disese. [] Access this rticle online Quick Response Code: Website: DOI: *** 0 0 Vol., Issue, Jnury-Mrch 0

2 0 0 There is mple evidence to implicte dentl plque s the primry etiologicl gent response for inflmmtory gingivl nd periodontl disese. [] Clinicl studies conducted in the mid 0 th century first documented the cuse nd effect reltionship between plque ccumultion nd the development of gingivitis in humns. [,] Plque is biofilm tht develops on the hrd tissue, primrily enmel, nd consists of bcteri, mucus, extrcellulr mtrix nd fluid chnnels. [,] Plque cts s reservoir for bcteri. Left lone, plque will eventully inflme the gingiv tht results in infection. This infection leds to gingivitis, generlly described s gingivl inflmmtion in the bsence of clinicl ttchment loss or the presence of reduced but stble ttchment levels, nd could eventully led to periodontitis, described s the presence of gingivl inflmmtion t sites where there hs been picl migrtion of the epithelium onto the root surfce with the concomitnt loss of connective tissue nd lveolr bone. [ ] Dily home cre is n importnt element of orl helth. However, even with effective tooth clening, bcteri colonize the tooth surfce, nd the developing biofilm (plque) releses vriety of biologiclly ctive products tht diffuse into the gingivl epithelium to initite the host response tht eventully results in gingivitis. [] More recent reserch strongly suggests tht the orl inflmmtion cused by the bcteri living in the dentl plque my contribute to vrious systemic diseses, including dibetes, coronry hert disese, peripherl rteril disese, crdiovsculr disese, ischemic stroke, low birth weight, preterm bbies nd osteoporosis. [,] It is undisputed tht people do not consistently perform home orl cre procedures t n cceptble level. [] As such, orl helth reserchers hve looked for compounds which when incorported into dentifrices provide cliniclly proven ntiplque nd ntigingivitis benefits. One such compound tht hs been shown in multitude of clinicl studies to hve these benefits is triclosn. It is bisphenolic ntibcteril gent, which hs low toxicity nd brod spectrum of ctivity, being effective ginst both Grm positive nd Grm negtive bcteri. [,] Triclosn hs been shown to be comptible with orl hygiene product ingredients nd sfe for consumer use. [ ] Objective To compre the effects of brushing with commercilly vilble dentifrice contining triclosn (Colgte Supershkti Dentl Crem) to brushing with dentifrice contining zinc citrte nd stnnous chloride (Crest Pro Helth All Good Effects Toothpste) nd Colgte CIBACA Toothpste, Colgte Plmolive Compny, Indi), over week period on estblished gingivitis nd suprgingivl dentl plque. MATERIALS AND METHODS This independent clinicl study employed double blind, strtified, three tretment prllel group study design, conducted t the Deprtment of Public helth Dentistry, SDM College of Dentl Sciences nd Hospitl, Dhrwd, Indi The protocol for this study ws reviewed nd pproved by n independent Institutionl Review Bord. Adult mle nd femle subjects from North West Krntk, Indi were enrolled into the study bsed upon the following criteri: Subjects: Hd to be between the ges of nd 0 (inclusive), in generlly good helth nd hd to hve signed n Informed Consent form Hd to be vilble for the durtion of the study Hd to possess t lest 0 uncrowned permnent nturl teeth (excluding third molrs) With plque index (PI) scores. ccording to the Quigley Hein PI scoring procedure nd gingivl index (GI) score.0 Hd to perform dequte orl hygiene with no signs of orl neglect, good periodontl helth nd no > periodontl pockets of mm. Subjects were excluded if: They hd five or more decyed untreted dentl sites t screening, other disese of the hrd or soft orl tissues, impired slivry function, were immune compromised individuls (HIV, AIDS, immune suppressive drug therpy) They hd tken medictions tht could ffect the study outcome, including but not limited to certin ntibiotics or ntimicrobil drugs, within month prior to the strt of the study or while prticipting in the study They were pregnnt or lctting women Individuls who were prticipting in ny other clinicl study or who hd prticipted in study within month prior to enrollment They presented orthodontic bnds; or prtil or removble dentures; or received dentl prophylxis nytime during the week prior to the first dentl exmintion or hd history of lcohol or drug buse they hd history of llergies to the test products, or llergies to orl cre/personl cre consumer products or their ingredients, or subjects with existing medicl conditions, which prohibits them from eting nd drinking for periods up to h They hd used triclosn contining dentifrice up to months prior to the strt of the study. Methods Prospective study subjects reported to the clinicl fcility hving refrined from ll orl hygiene procedures for h nd from eting, drinking or smoking for h prior to their screening visit. Subjects who met the inclusion/ 0 0 Vol., Issue, Jnury-Mrch 0

3 0 0 exclusion criteri, presented norml orl soft nd hrd tissue ssessment nd GI score.0 nd PI score. received commercilly vilble fluoride dentifrice nd soft bristled toothbrush nd were instructed to use only these products with no other orl hygiene products (mints, chewing gums, mouth rinses, etc.,) for week wshout phse. Subjects reported bck to the clinicl fcility hving refrined from ll orl hygiene procedures for h nd from eting, drinking or smoking for h to hve bseline ssessment of orl soft nd hrd tissues nd bseline gingivl nd plque exmintions. Subjects received demonstrtion of the brushing technique nd were sked to brush for minimum of min. Subjects were rndomly ssigned to one of the three tretment groups ccording to bseline gingivl nd PI scores. The first three received one ech of the three pstes, the next few were given the products fter rndomizing their plque nd gingivitis scores on the excel sheet, keeping tlly of mens nd stndrd devitions. Tretment groups A dentifrice contining 0.% triclosn nd 00 ppm fluoride s sodium (mrketed s Colgte Supershkti Dentl Crem, Colgte Plmolive Compny, Indi) A dentifrice contining 0.% zinc citrte, 0.% stnnous chloride nd 0.% sodium fluoride (mrketed s Crest Pro Helth All Good Effects Toothpste, Procter nd Gmble Compny, Chin) A dentifrice contining 00 ppm fluoride s sodium (mrketed s Colgte CIBACA Toothpste, Colgte Plmolive Compny, Indi). Subjects were provided with soft bristle toothbrush nd their ssigned dentifrice tht ws over wrpped in its originl pckge to mintin the double blind study design. Subjects were instructed to brush their teeth with their ssigned toothpste nd toothbrush twice dily (morning nd evening) for min, nd to use only the toothpste nd toothbrush provided. After week, subjects reported to the clinicl fcility fter refrining from orl hygiene for h period nd from eting, drinking nd smoking for h where they received n orl hrd nd tissue ssessment nd gingivl nd plque exmintion. A visit form ws completed for ech subject during every visit nd ws used to determine if there ws reson to exclude subject from continuing in the study or to exclude the dt from sttisticl nlysis. Clinicl scoring procedures Gingivitis ws scored ccording to the Loe nd Silness GI [0] s modified by Tlbott et l. [] Suprgingivl dentl plque ws scored ccording to the Turesky Modified Quigley Hein PI to determine the presence or bsence of suprgingivl plque. [,] Third molrs nd teeth with cervicl restortions or prosthetic crowns were excluded from the scoring procedure. Whole mouth men scores were obtined by verging the vlues recorded overll scorble tooth surfces in the mouth. The dentl exminer visully exmined the orl cvity nd peri orl re using dentl light nd dentl mirror. This exmintion included n evlution of the soft nd hrd plte, gingivl mucos, buccl mucos, mucogingivl fold res, tongue, sublingul nd submndibulr res, slivry glnds nd the tonsilr nd phryngel res. Adverse events were obtined from n interview with the subjects nd from dentl exmintion by the exmining dentist. Sttisticl nlyses Sttisticl nlyses were performed seprtely for the gingivitis ssessments nd suprgingivl plque ssessments. Comprison of the tretment groups with respect to gender were performed using Chi squre nlysis nd for ge n independent t test. Comprisons of the tretment groups with respect to bseline GI scores nd PI scores were performed using n nlysis of vrince. Within tretment comprisons of the bseline versus week GI scores nd PI scores were performed using pired t test. Comprisons of the tretment groups with respect to bseline djusted GI scores nd PI scores t the week exmintions were performed using nlyses of covrince (ANCOVA s). Post ANCOVA pir wise comprisons of the study tretments were performed using the Tukey s test for multiple comprisons. All sttisticl tests of hypotheses were two sided, nd employed level of significnce of α =0.0. RESULTS One hundred nd twenty ws the estimted smple size with 0 individuls in ech group. Following bseline exmintion, ssuming n occurrence of dropouts owing to migrtion, unforeseen helth events nd other resons, individuls were recruited. Out of, subjects entered the clinicl study, complied with the protocol nd completed the week clinicl study. A summry of the gender nd ge of the study groups is presented in Tble. The tretment groups did not differ significntly with respect to either of these chrcteristics. Bseline dt The men bseline GI scores were. for the triclosn/sodium dentifrice group,. for the zinc citrte/stnnous chloride/sodium fluoride dentifrice group nd. for the sodium dentifrice group. The men bseline PI scores were. for the triclosn/sodium dentifrice group,. for the zinc 0 0 Vol., Issue, Jnury-Mrch 0

4 0 0 citrte/stnnous chloride/sodium fluoride dentifrice group nd. for the sodium dentifrice group. No sttisticlly significnt differences were observed mong the tretment groups with respect to GI or PI scores t bseline [Tble ]. Six weeks dt Gingivitis Tble presents summry of the GI scores mesured fter week of product use. Six weeks versus bseline The men week GI scores were. for subjects in the triclosn/sodium dentifrice group,. for subjects in the zinc citrte/stnnous chloride/sodium fluoride dentifrice group nd.0 for subjects in the sodium dentifrice group. The men percent reductions from bseline were.% for subjects in the triclosn/sodium dentifrice group,.% for subjects in the zinc citrte/stnnous chloride/sodium fluoride dentifrice group nd.% for subjects in the sodium dentifrice group, ll being sttisticlly significnt (P < 0.0). Comprison between tretment groups When compred to subjects in both the zinc citrte/ stnnous fluoride/sodium fluoride dentifrice group nd sodium monofluorophoste dentifrice group, the triclosn/sodium dentifrice group exhibited sttisticlly significnt (P < 0.0) reductions of.% nd.% respectively in GI scores fter week of product use. The sodium dentifrice group exhibited.% nonsttisticlly significnt reduction (P > 0.0) in GI scores when compred to the zinc/citrte/stnnous fluoride/sodium fluoride dentifrice group. Plque Tble presents summry of the PI scores mesured fter week of product use. Six weeks versus bseline: The men week PI scores were. for subjects in the triclosn/sodium Tble : Age nd gender chrcteristics of the study subjects Tretment Number of subjects Drop outs Age Mle Femle Totl Men Rnge Triclosn/sodium. Zinc citrte/stnnous chloride/sodium fluoride. Sodium. No sttisticlly significnt difference ws indicted mong the three tretment groups with respect to either gender or ge Tble : Bseline gingivl index nd plque index scores of the study subjects Prmeter Tretment n Bseline (men±sd) Gingivl index Triclosn/sodium.±0. Zinc citrte/stnnous chloride/sodium fluoride.±0. Sodium.±0. Plque index Triclosn/sodium.±0. Zinc citrte/stnnous chloride/sodium fluoride.±0. Sodium.±0. No sttisticlly significnt difference in gingivl index scores nd plque index scores mong the three tretment groups t bseline. SD: Stndrd devition Tble : Gingivl index scores of the study subjects fter week clinicl study Tretment n week (men±sd) Within tretment nlysis Between tretment comprison Triclosn/sodium Zinc citrte/stnnous chloride/sodium fluoride Sodium Versus zinc citrte/stnnous chloride/ sodium fluoride dentifrice group Versus sodium dentifrice group Percent chnge Significnce b Percent difference c Significnce e Percent difference d Significnce e.0±0.. P<0.0. P<0.0. P<0.0.±0.. P<0.0.±0.. P<0.0. P>0.0 Percent chnge exhibited by the week men reltive to the bseline men, b Significnce of pired t test compring the bseline nd the week exmintions, c Difference between the week mens expressed s percentge of the week men for the zinc citrte/stnnous chloride/sodium fluoride dentifrice, d Difference between the week mens expressed s percentge of the week men for the sodium dentifrice, e Significnce of ANCOVA comprison of bseline djusted mens. SD - Stndrd devition, ANCOVA - Anlyses of covrince 0 0 Vol., Issue, Jnury-Mrch 0

5 0 0 Tble : Plque index scores of the study subjects fter week clinicl study Tretment n week (men±sd) Within tretment nlysis Between tretment comprison Triclosn/sodium Zinc citrte/stnnous chloride/sodium fluoride Sodium dentifrice group,. for subjects in the zinc citrte/stnnous chloride/sodium fluoride dentifrice group nd. for subjects in the sodium dentifrice group. The men percent reductions from bseline were.% for subjects in the triclosn/sodium dentifrice group,.% for subjects in the zinc citrte/stnnous chloride/sodium fluoride dentifrice group nd 0.% for subjects in the sodium dentifrice group, ll being sttisticlly significnt (P < 0.0). Comprison between tretment groups: Compred to subjects in both the zinc citrte/stnnous fluoride/ sodium fluoride dentifrice group nd the sodium monofluorophoste dentifrice group, the triclosn/ sodium dentifrice group exhibited sttisticlly significnt (P < 0.0) reductions of.% nd.% respectively, in PI scores fter week of product use. The sodium dentifrice group exhibited.% nonsttisticlly significnt reduction (P > 0.0) in PI scores when compred to the zinc/citrte/stnnous fluoride/sodium fluoride dentifrice group. Adverse events Throughout the study, there were no dverse events on the orl soft nd hrd tissue of the orl cvity observed by the exminer, or reported by the subjects when questioned. DISCUSSION Plque control is the foundtion of ny ttempt to prevent nd control periodontl disese. It is well ccepted tht most people fil to chieve level of orl hygiene commensurte with periodontl helth. [,] Periodontl disese is initited by plque bcteri, nd orl helth focus hs centered on the possibility of enhncing orl hygiene by incorporting chemotherpeutic gents into dentifrices formultions. Agents tht, mong others, hve been shown to hve ntiplque properties re triclosn, Percent chnge Significnce b Versus zinc citrte/stnnous chloride/ sodium fluoride dentifrice group Versus sodium dentifrice group Percent difference e Significnce d Percent difference c Significnce d.±0.. P<0.0. P<0.0. P<0.0.±0.. P<0.0.±0. 0. P<0.0. P>0.0 Percent chnge exhibited by the week men reltive to the bseline men, b Significnce of pired t test compring the bseline nd week exmintions, c Difference between the week mens expressed s percentge of the week men for the sodium dentifrice, d Significnce of ANCOVA comprison of bseline djusted mens, e Difference between the week mens expressed s percentge of the week men for the zinc citrte/stnnous chloride/sodium fluoride dentifrice. SD - Stndrd devition, ANCOVA - Anlyses of covrince stnnous slts, nd zinc slts. This double blind clinicl study provided n investigtive comprison of the clinicl efficcy of three commercilly vilble dentifrices mrketed in Indi with respect to the reduction of gingivitis nd suprgingivl dentl plque over week period. One dentifrice, Colgte Supershkti Dentl Crem contins 0.% triclosn nd 00 ppm sodium. The second dentifrice, Crest Pro Helth All Good Effects Toothpste contins 0.% zinc citrte/0.% stnnous chloride/0.% sodium fluoride. The negtive control dentifrice is commercilly vilble 00 ppm sodium dentifrice (Colgte CIBACA Toothpste). Triclosn, lone nd in combintion with Polyvinyl methyl ether/mleic cid (PVM/MA) copolymer, hs consistently shown ntigingivitis nd ntiplque efficcy in numerous clinicl studies. [ ] Triclosn, phenolic ntibcteril nd nti inflmmtory gent with low toxicity nd brod spectrum of ctivity, hs been shown to be effective ginst Grm positive nd Grm negtive bcteri. The stnnous chemistry is complex s severl species form upon hydrtion of stnnous fluoride or its rection with dentl hrd tissue. Due to the rective nture of the tin (II) ion, it hs to be stbilized in formultion to prevent it from being oxidized nd consequently becoming insoluble nd ineffective. [,] Stnnous slts require low ph formultions nd the presence of gluconte nd/or olflur (mine fluoride) tht ct s cheltors for optimum stbility. Combining stnnous fluoride nd stnnous chloride into dentifrice formultions hs been wy to increse stnnous concentrtion since the mount of stnnous from stnnous fluoride is limited by regulted fluoride concentrtions. Zinc slts hve been combined with stnnous slts or used lone. The two most used zinc slts re citrte nd chloride, both shown to hve some ntiplque efficcy. [,] This clinicl study t the week exmintions showed tht ll the subjects in the triclosn/sodium dentifrice group, zinc citrte/ stnnous fluoride/sodium fluoride dentifrice group, 0 0 Vol., Issue, Jnury-Mrch 0

6 0 0 nd sodium dentifrice group exhibited sttisticlly significnt (P < 0.0) reductions (.%,.% nd.% respectively) from bseline with respect to GI scores. In ddition, ll the subjects in the triclosn/sodium dentifrice group, zinc citrte/stnnous fluoride/sodium fluoride dentifrice group, nd sodium dentifrice group exhibited sttisticlly significnt (P < 0.0) reductions (.%,.% nd 0.% respectively) from bseline with respect to PI scores. The results of this study showed tht fter week of twice dily tooth brushing, subjects using the triclosn/sodium dentifrice exhibited sttisticlly significnt (P < 0.0) reductions (.% nd.% respectively) in GI scores when compred to subjects in both the zinc citrte/stnnous chloride/sodium fluoride dentifrice nd the sodium dentifrice groups. Also t the week exmintions, subjects in the triclosn/sodium dentifrice group exhibited sttisticlly significnt (P < 0.0) reductions (.% nd.% respectively) in PI scores when compred to subjects in both the zinc citrte/ stnnous fluoride/sodium fluoride dentifrice nd the sodium dentifrice groups. Limittions nd recommendtions This ws week study with evlutions conducted t bseline nd week use of n ssigned test toothpste. Presented in the literture re studies of longer durtion tht offer dditionl insights on the effects of toothpstes on mintining dentl plque nd gingivl sttus. Bsed on the present results, future efforts evluting longer term effects cn be proposed. CONCLUSION The results of this double blind clinicl study support tht the commercilly vilble dentifrice contining 0.% triclosn nd 00 ppm sodium (COLGATE SUPERSHAKTI Dentl Crem), commercilly vilble dentifrice contining 0.% zinc citrte, 0.% stnnous chloride nd 0.% sodium fluoride (CREST PRO HEALTH All Good Effects Toothpste), nd commercilly vilble 00 ppm sodium dentifrice (COLGATE CIBACA Toothpste) provided sttisticlly significnt reductions (P < 0.0) in gingivitis nd suprgingivl dentl plque fter week of product use. The results lso support the tht commercilly vilble dentifrice contining 0.% triclosn nd 00 ppm sodium (COLGATE SUPERSHAKTI Dentl Crem) provided sttisticlly significnt greter reductions (P < 0.0) in gingivitis nd suprgingivl dentl plque when compred to the CREST PRO HEALTH All Good Effects Toothpste (0.% zinc citrte, 0.% stnnous chloride, 0.% sodium fluoride) nd the COLGATE CIBACA Toothpste (00 ppm sodium ). REFERENCES. Silness J, Loe H. Periodontl disese in pregnncy. II. 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