Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial.

OBJECTIVES: To compare the effectiveness of using a 0.454% stannous fluoride-containing dentifrice twice daily in relieving dentinal hypersensitivity (DH) in a Chinese population. MATERIALS AND METHODS: This was a single-centre, randomized, controlled, examiner-blind, three-treatment-arm, parallel-group study in participants with clinically diagnosed DH. Subjects who met inclusion criteria (n = 197) were randomly allocated into 3 groups: test group (n = 66)-using a 0.454% stannous fluoride-containing dentifrice twice daily; positive control group (n = 64)-using a 5.0% calcium sodium phosphosilicate-containing dentifrice twice daily; negative control group (n = 67)-using a 1150 ppm of NaF dentifrice twice daily. Status of DH was assessed at week 4 and week 8 by the same independent examiner. Changes from baseline in Schiff sensitivity score, tactile threshold and Dentine Hypersensitivity Experience Questionnaire (DHEQ) score were analysed using analysis of covariance models. The DHEQ evaluated subject-perceived oral health-related quality of life (OHRQoL). RESULTS: Statistically significant improvements in mean Schiff scores (p < 0.0001 for all products at Weeks 4 and 8), tactile threshold (p < 0.0001 for test and negative control at Weeks 4 and 8: Week 4 p = 0.0040 and Week 8 p < 0.0001 for positive control) and all DHEQ scores (p < 0.01 for all groups) were observed. No statistically significant differences were observed in the adjusted mean between all dentifrices at both timepoints, potentially driven by a placebo effect. Forty-two treatment-emergent adverse events (TEAEs) were reported (n = 32 subjects), with 2 serious AEs (n = 1) in the test group. TEAEs were not considered treatment-related. CONCLUSIONS: All groups demonstrated statistically significant improvements in Schiff score, tactile threshold and OHRQoL. However, due to a possible placebo effect in the negative control, there were no statistically significant differences between the dentifrices. CLINICAL RELEVANCE: This study adds to the growing research exploring why the placebo effect is a common phenomenon in DH studies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04950465.

Antibacterial effects of dentifrices against Streptococcus mutans in children: a comparative in vitro study.

Fluoridated dentifrices have antibacterial effects on children's teeth. On the other hand, the side effects encountered with the use of them have led researchers to look for safe alternatives. This study aimed to determine the antibacterial effect of different commercially available fluoride-free dentifrices on Streptococcus mutans (S. mutans) in comparison with different concentrations of fluoridated dentifrices. Study groups comprised of fluoride-free dentifrices, which contain Probiotic (Activated Charcoal Probiotic Dentifrice-Group P), Aloe Vera-Group AV and Salivary Proteins-Group SP. Fluoridated dentifrices containing 1450 ppm fluoride-Control Group 1 and 500 ppm fluoride-Control Group 2 served as control groups. Antibacterial activity was assessed by Minimum Inhibitory Concentrations and agar well diffusion assays on S. mutans. Biofilm inhibition assay was performed with dentifrices, which had antibacterial activities, and a negative control phosphate-buffered saline (Group PBS) on sterile hydroxyapatite discs against S. mutans. Statistical evaluation was performed. Only group AV showed an antibacterial effect on S. mutans, while control groups showed a similar antibacterial effect. The mean number of viable bacteria present in S. mutans biofilm in Control Group 1 and 2 and Group AV were statistically significantly lower than that in Group PBS, but there were no statistically significant differences between Control Groups and Group AV. Antibacterial activity of commercial dentifrices against S. mutans may be exerted by antibacterial components other than fluoride. Aloe vera-containing toothpaste showed an antibacterial effect on S. mutans, although not as much as the fluoride-containing toothpastes in the control groups. However, further in vivo and long-term studies are required.

A dentifrice containing salivary enzymes and xylitol exhibits superior antimicrobial activity in vitro against adherent Streptococcus mutans compared to a chlorhexidine dentifrice.

Human saliva contains natural antimicrobial enzymes. In this in-vitro study, we evaluate the antimicrobial activity of a dentifrice containing a salivary enzyme complex (SEC) with xylitol versus a standard 0.12% chlorhexidine (CHX) dentifrice. Adherent cells of Streptococcus gordonii, Strep. mutans, Actinomyces naeslundii, Fusobacterium nucleatum subsp polymorphum, and Corynebacterium matruchotii were exposed to SEC-xylitol and CHX dentifrices for 2 min and viable CFUs were enumerated. Exposure to the SEC-xylitol dentifrice resulted in a significant reduction in bacterial viability, which was greater than that shown by the CHX dentifrice, against all organisms tested. The SEC-xylitol dentifrice also exhibited greater antimicrobial activity against all organsims in well diffusion assays compared to CHX. Dentifrice activity was also evaluated against a three species community of Strep. gordonii, Strep. mutans, and Coryne. matruchotii using bacterial live/dead stain. The SEC-xylitol dentifrice was at least as effective as CHX in removal of the multispecies community. The combination of SEC and xylitol generates a highly effective antimicrobial dentifrice with greater antibacterial activity than a standard 0.12% CHX formulations. SEC and xylitol combinations are worthy of further investigation for routine use and in the management of gingivitis and periodontal disease.

In vitro assessment of activated charcoal-based dental products.

OBJECTIVE: Assess the effects of activated charcoal-based products on whitening and changes on dental enamel surface. MATERIAL AND METHODS: Fifty-two blocks of bovine dental enamel were randomly distributed in four groups (n = 13): brushing with activated charcoal-based powder (PW); brushing with activated charcoal-based dentifrice (AC); brushing with a conventional dentifrice containing 1450 ppm of fluoride (CD); and whitening with 10% carbamide peroxide (CP). Color, microhardness, and surface alteration were analyzed at baseline and after 14 days of treatment. Three samples per group were randomly selected and examined using scanning electron microscopy (SEM) to analyze the morphology. RESULTS: PW exhibited greater color change for the ΔE00 , ΔWID, Δb* and ΔL* parameters than other groups (p < 0.05). After treatment, microhardness decreased in AC and CP groups (p < 0.05). Also, PW and AC groups showed more surface alteration than CD and CP (p < 0.001). Changes in the morphology of dental enamel were observed by SEM in PW and AC groups. CONCLUSION: Activated charcoal-based products showed a lower whitening effect than 10% carbamide peroxide. These products also influenced dental enamel microhardness, resulting in greater surface alteration. CLINICAL SIGNIFICANCE: Activated charcoal-based products promoted minimum whitening effects with significant enamel surface alteration. The 10% carbamide peroxide was more effective for whitening and caused slight enamel surface alteration.

The anti-plaque effect of high concentration sodium bicarbonate dentifrice on plaque formation and gingival inflammation, irrespective to individual polishing technique and plaque quality.

AIM: To assess the anti-plaque effect of a high concentration sodium bicarbonate dentifrice on plaque formation, and gingivitis, as compared to a control toothpaste, irrespective of individual brushing technique and plaque quality. METHODS: The experimental gingivitis model, with a split-mouth design was used to assess the anti-plaque effect of a high concentration sodium bicarbonate dentifrice on plaque formation. By producing individual fitted trays, the toothpaste was applied in the test quadrant and a control dentifrice in the contralateral. The participants used the individual fitted trays for 1 min every morning and evening, for 21 days. In this period, the participants was only allowed to brush the teeth in the opposite jaw, as usual. Twenty healthy individuals successfully completed the study. RESULTS: At 21 days, there was no statistically significant difference between test quadrant and control quadrant with regard to plaque indices, gingival index and number of bleeding sites. CONCLUSION: This study demonstrated that the high concentration sodium bicarbonate dentifrice used did not produce statistically significant anti-plaque effect compared to the control dentifrice, in terms of Plaque- and Gingival Indices, number of bleeding sites or by Quigely and Hein, the Turesky modification Plaque Index, irrespective of brushing technique and individual plaque quality. TRIAL REGISTRATION: Regional Committee for Medical Research and Ethics, South-East Norway in 2021 (REK.2021/370116). CLINICAL TRIAL REGISTRATION: NCT05441371 (First registered 09/06/2022, First posted 01/07/2022) ( http://www. CLINICALTRIALS: gov ). (Retrospectively registered).

Impact of the uninstructed use of a herbal, ayurvedic toothpaste on parameters of gingival health in periodontal aftercare patients: A randomized, double-blinded, two-arm parallel-group study.

AIM: The aim of this study was to evaluate the impact of the uninstructed use of a toothpaste containing herbal ayurvedic ingredients on parameters of gingival health in a cohort of periodontal aftercare patients affected by gingival inflammation compared to the use of a standard, non-herbal toothpaste. MATERIALS AND METHODS: The monocentric, randomized, double-blinded, two-arm parallel-group intervention was performed in a cohort of 88 periodontal aftercare patients with clinical signs of gingival inflammation. At baseline, bleeding on probing (BoP), gingival index (GI) and Quigley-Hein plaque index (QHI) were recorded. Subsequently, the study patients were randomly provided with a herbal ayurvedic toothpaste (n = 44) or a conventional, non-ayurvedic control toothpaste (n = 44) and without additional oral hygiene training instructed to use it 2× daily for the next 28 days. On day 28, BoP, GI and QHI were recorded again. RESULTS: At baseline, there were no significant differences between both groups. On day 28, mean GI and BoP scores were significantly lower (p < 0.001) compared to baseline in both groups. Differences between the groups could not be verified. Mean QHI scores did not change significantly between day 0 and day 28 in both groups. CONCLUSIONS: The impact of uninstructed toothbrushing with an ayurvedic toothpaste on the manifestation of gingival inflammation in periodontal aftercare patients is not significantly different to the use of a conventional, non-herbal toothpaste.

Soluble Fluoride in Na2FPO3/CaCO3-Based Toothpaste as an Indicator of Systemically Bioavailable Fluoride.

Fluoride chemically soluble in toothpaste is an indicator of fluoride bioavailability when the teeth are brushed, and the same should be expected systemically when toothpaste is ingested. A 4-phases study was conducted, in which 8 participants were subjected in each phase to one of the assigned treatment groups: group I: fresh sample of a Na2FPO3/CaCO3 toothpaste with 1,334 µg F/g of total soluble fluoride (TSF) and groups II-IV: aged samples of toothpaste presenting TSF concentrations of 1,128, 808, and 687 µg F/g, respectively. In all phases, the participants ingested an amount of toothpaste equivalent to 70.0 µg F/kg body weight, as total fluoride (TF). Blood was collected before (baseline) and up to 180 min after toothpaste ingestion as indicator of fluoride bioavailability. Total urine (24 h before and 24 h after ingestion) was collected as indicator of absorbed fluoride that was excreted. F concentration in blood plasma and urine was determined with a fluoride ion-specific electrode. The areas under the curve (AUC) of F concentration versus time (AUC = ng F/mL × min) and the peaks of fluoride concentration in blood plasma (Cmax) were calculated. The net amount of fluoride excreted (mg/day) was calculated by subtraction. A significant correlation of the amount (mg) of TSF ingested was found between the AUC (r = 0.76; p < 0.01) and Cmax (r = 0.86; p < 0.01) in plasma, and the fluoride excreted (r = 0.65; p < 0.01). For TF, no statistical correlations were found (p > 0.05). Data suggest that the concentration of TSF found in Na2FPO3/CaCO3-based toothpastes is a useful predictor of how much fluoride will be systemically bioavailable when this type of formulation is ingested.

Does the application of whitening dentifrices during at-home bleaching affect the bond strength of resin composite to dentin?

AIM: This study aimed to evaluate the effect of using whitening dentifrices during at-home bleaching on the shear bond strength (SBS) of resin composite to dentin, and investigate whether the increased polymerization time would improve SBS. METHODS: Ninety-six bovine incisors were divided into 4 groups of 24, according to the whitening treatment applied as follows: group 1, at-home bleaching + brushing with a regular dentifrice; group 2, at-home bleaching + brushing with a whitening dentifrice containing ozone; group 3, at-home bleaching + brushing with a commercial whitening dentifrice; and group 4 (control), no whitening/brushing treatment. Each group was divided into two subgroups (n = 12) to assess the effect of curing time (20 versus 80 s) on SBS. A self-etch adhesive was bonded to dentin, and after 2-day water storage, SBS was determined. RESULTS: SBS was significantly affected by the whitening treatment (P = 0.03), but increasing the curing time had no significant effect on SBS (P = 0.137). Bond strength in group 1 was comparable to the control group (P > 0.05). The specimens in group 3 displayed significantly lower SBS than either group 4 or group 1 (P > 0.05). No significant difference was observed between the SBS of group 2 compared to any other group (P > 0.05). There was no significant association between the treatment group and failure type (P > 0.05). CONCLUSION: The bonding interface was not negatively influenced by the at-home bleaching procedure. However, using a commercial whitening dentifrice during at-home bleaching produced a significant detrimental effect on SBS. Extending the curing time would have no beneficial effect on adhesion to a whitened dental substrate.

EFFICACY OF 67% SODIUM BICARBONATE TOOTHPASTE FOR PLAQUE AND GINGIVITIS CONTROL: A SYSTEMATIC REVIEW AND META-ANALYSIS.

OBJECTIVE: Previous studies demonstrated a dose-dependent efficacy of sodium bicarbonate when added to dentifrices for the mechanical control of dental biofilm. The present systematic review and meta-analysis aimed to evaluate the efficacy of a 67% sodium bicarbonate-based toothpaste for gingival health parameters improvement in subjects with gingivitis. MATERIALS AND METHODS: An electronic search on MEDLINE, Scopus, and Cochrane Central Register of Controlled Trials (CENTRAL), was performed using a combination of keywords, followed by a hand search on pertinent Journals. Randomized controlled trials (RCTs) and prospective comparative studies in English language were included. There was no publication date and language restriction. The data regarding gingival, bleeding, and plaque index were extracted from the selected studies. Included studies underwent risk-of-bias assessment. When at least 3 studies reporting the same outcome were found, a meta-analysis was undertaken, to estimate the combined effect. Trial Sequential Analysis (TSA) was also performed to evaluate the power of the meta-analysis for primary outcomes. RESULTS: The search strategy yielded 83 articles. After screening, 7 RCTs were included. Three were at high risk, one at moderate risk, and 3 at low risk-of-bias. Significant improvement of gingival index, bleeding index, and plaque index was observed in patients using 67% sodium bicarbonate toothpaste as compared with control subjects. TSA showed sufficient power for modified Gingival index and bleeding scores. CONCLUSIONS: The clinical use of 67% sodium bicarbonate toothpaste can improve periodontal health in patients with gingivitis.

Objective assessment of simulated non-carious cervical lesion by tridimensional digital scanning.

OBJECTIVE: To explore the use of 3D intraoral scanner/image analysis for the detection and monitoring of simulated non-carious cervical lesions (NCCLs) in vitro. MATERIALS AND METHODS: A total of 288 NCCLs of different severities and simulated using a laboratorial model associating toothbrush stiffness (soft, medium, and hard) and toothpaste abrasivity (low, medium, high, and negative control) were analyzed. Dental impressions were taken from specimens before and after 35K and 65K brushing strokes, and then scanned with a CEREC Omnicam scanner. 3D models were analyzed for volumetric tooth loss. 3D optical profilometry was considered as the gold standard. Data were analyzed using ANOVA and Fisher's PLSD tests (alpha = 0.05), and agreement between methods by using intraclass correlation coefficient. RESULTS: Toothbrushes of hard and mid stiffness caused higher tooth loss than soft when associated with the highest abrasive, at 35K and 65K strokes (p < 0.001). Variation in slurry abrasivity led to differences in tooth loss (with control < low < medium < high, p < 0.0001) after both 35K and 65K strokes, regardless of the type of toothbrush used, except at 35K, wherein control = low (p = 0.55). 35K strokes caused less tooth loss than 65K for all abrasive slurries (p < 0.0001) except controls. The intraclass correlation coefficient for agreement between the test and gold standard methods was 0.85. CONCLUSIONS: Analysis of 3D images from intraoral scanner could detect and monitor NCCL progression, although this ability was limited on incipient lesions. Overall good agreement was found between the test method and optical profilometry. CLINICAL RELEVANCE: The suggested method may be applicable to detect and monitor NCCLs clinically.

The effects of a novel herbal toothpaste on salivary lactate dehydrogenase as a measure of cellular integrity.

OBJECTIVE: Lactate dehydrogenase (LDH) is a critical intracellular enzyme responsible for anaerobic respiration in pyruvate metabolism which becomes detectable in extracellular spaces after cellular breakdown. This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, i.e., clove (Syzygium aromaticum), aloe vera (Aloe barbadensis), amla (Emblica officinalis), neem (Azadirachta indica), tulsi (Ocimum basillicum), and honey (from Apis mellifera), and 0.96% zinc (zinc oxide, zinc citrate) and 0.76% SMFP (1000 ppm F) in a calcium carbonate base formulated with natural ingredients (Ved Shakti, Colgate Palmolive India) and a fluoride toothpaste containing 0.76% SMFP (1000 ppm F) in a calcium carbonate base (Colgate Cavity Protection, Colgate Palmolive; henceforth control) on salivary LDH in conjunction with the assessments of dental plaque and gingivitis representing oral hygiene parameters. MATERIALS AND METHODS: This double-blind, two-cell study enrolled 70 adults (age range 20-59 years). Subjects completed a washout and provided baseline saliva samples for LDH analysis and clinical assessments of dental plaque and gingivitis using the Turesky Modification of Quigley-Hein and Loe-Silness methods respectively. Subjects were randomly assigned to brush their teeth with either the test or control. Post-treatment sample collection and clinical evaluations were conducted after 3 weeks, 6 weeks, and 12 week sof brushing with all assessments conducted 12 h after hygiene. Statistical analyses were conducted independently for each parameter by t-test for within treatment evaluation and analysis of covariance (ANCOVA) for between treatment comparisons. RESULTS: At baseline, treatment groups demonstrated no significant differences for LDH or dental plaque and gingival index scores. Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control. The test demonstrated reductions in LDH of 9.5-15.4% over the study period in comparison to the control representing statistically significant effects (p < 0.05). The test also demonstrated reductions in dental plaque that ranged between 6.4 and 16.2% over the study period and gingivitis reductions that ranged between 8.2 and 23.8% representing statistically significant results (p < 0.05). CONCLUSIONS: Brushing with a novel herbal toothpaste demonstrated significant reductions in salivary LDH representing improvements in cellular integrity with concurrent reductions in dental plaque and gingivitis as compared to the control dentifrice. CLINICAL RELEVANCE: Salivary LDH measurements offer a non-invasive and objective measurement of mucosal cellular integrity complementing other evaluations and clinical assessments such as plaque and gingival index scores.

Relationships between parental education, choice of child dentifrice, and their children's caries experience.

BACKGROUND: The influence of parental education, choice of child dentifrice, and its impact on their children's dental caries experience remain unclear. AIM: To investigate (a) dentifrice types used by Australian pre-school children, (b) demographic factors that influence parents' dentifrice choice, and (c) whether dentifrice type is related to pre-schooler's caries experience. DESIGN: 155 parent-child dyads were recruited from five random metropolitan childcare centres. Parents completed a questionnaire recording relevant demographics and child dietary preferences, oral hygiene practice, and dental visits. One calibrated operator performed a clinical examination of their pre-schooler for evidence of carious lesions. Data were analysed, and comparisons between variables made using chi-square tests and regression models. RESULTS: 50% of pre-schoolers used <1000 ppm fluoride dentifrice and 29% used non-fluoridated dentifrice. Higher parental education level was associated with the use of non-fluoridated dentifrice (P = .02, χ2  = 0.034). Children with higher brushing frequency were more likely to use fluoridated dentifrice (P = .03, χ2  < 0.001). CONCLUSION: The proportion of Australian pre-schoolers using non-fluoridated dentifrice was higher than in other world regions. Higher parental education level was strongly associated with choosing non-fluoridated toothpaste, which warrants further qualitative analysis to assess determinants for parents' choice of child dentifrice.

Effects of desensitizing dentifrices on dentin tubule occlusion and resistance to erosive challenges.

BACKGROUND: Many studies have demonstrated efficacy of casein phosphopeptide (CPP) containing products for dentin tubule occlusion for treatment of dentin sensitivity, but their effectiveness under dynamic erosive challenges remains to be elucidated. The purpose of the present study was to investigate the effectiveness of a desensitizing dentifrice containing CPP in occluding dentin tubules and resisting erosive challenges in comparison to that containing polyvinyl methyl ether/maleic acid (PVM/MA) copolymers. METHODS: A total of 33 dentin discs were prepared from coronal sections of human third molars and divided into 3 groups: a toothpaste containing CPP; a toothpaste containing PVM/MA and submicron silica; and a regular toothpaste (Controls). A soft-bristle toothbrush was used to brush the dentin discs with the dentifrices for 45 strokes in 30 s at a force of approximately 200 g. The brushing cycle was repeated after immersion of the dentin discs in artificial saliva overnight. The dentin discs were then challenged in orange juice for 10 min in an incubator rocking at 120 rpm. Three fields were randomly selected on each dentin disk surface to assess dentin tubule occlusions after each brushing cycle and after orange juice challenge with a 3D laser scanning microscope. Specimen cross sections were examined with a scanning electron microscope equipped with energy dispersive spectroscopy (SEM/EDS). RESULTS: After the first and second cycles of brushing, dentin tubules were occluded on average by 56.3% and 85.7% in CPP group, 66.2% and 88.1% in PVM/MA group, and 0.0 and 13.0% in the controls, respectively. There were no statistically significant differences in dentin tubule occlusions between the CPP and PVM/MA groups after two cycles of brushing (p>0.05). After dynamic erosive challenges with orange juice, 20.3% of the dentin tubules in the CPP group, 79.1% in the PVM/MA group and none in the control remained occluded (P<0.05). SEM/EDS imaging showed that dentin tubules were blocked with plugs containing dentifrice substances in CPP and PVM/MA groups after treatments, but none in the controls. CONCLUSIONS: Desensitizing dentifrices containing CPP or PVM/MA could effectively occlude dentin tubules after two cycles of brushing. PVM/MA in combination with submicron silicon dioxide exhibited stronger resistance to dynamic erosive challenges by acidic beverages. Inorganic fillers that can enter dentin tubules and resist erosive challenges may be key for desensitizing dentifrices.

Do natural ingredients in a dentifrice contribute to prevention of plaque and gingivitis?

OBJECTIVE: To test the effectiveness of a dentifrice containing the turmeric and licorice extract compared to a control for preventing plaque and gingivitis over a four-month period. MATERIAL AND METHODS: Ninety (non-dental) participants with moderate gingival inflammation (≥ 40%) were selected. The triple blind study consisted of two phases, namely at first a 3-week pre-experimental phase of using an oxygenating and chlorhexidine (CHX) mouthrinse. Secondly, a 4-month experimental period in which participants were randomly assigned to a test or control group. All were instructed to brush their teeth twice daily for 2 minutes with their assigned dentifrice. Gingival bleeding (BI), plaque (PI) and gingivitis (GI) were assessed. RESULTS: Eighty participants completed the protocol. At the first assessment in the pre-experimental phase, the mean scores of all indices showed no differences for the two groups. At the second session, the values of all three parameters had decreased significantly (p < 0.001). At the last session, the BI values were 0.52(0.25) for the test group and 0.56(0.25) for the control, the mean GI was 0.27(0.17) for the test group and 0.31(0.16) for the control, and for PI the scores were 1.89(0.46) for the test group and 1.98(0.43) for the control group. Statistical comparison of the scores for the two groups at each stage of the study showed no significant difference for any of the parameters. CONCLUSION: Within the limits of the current study design, dentifrice formulation and concentration of turmeric/licorice extracts, the results show that the adjuvant effect of the natural ingredients in the test dentifrice was not evident on clinical parameters of gingivitis and plaque.

A randomized clinical study to examine the oral hygiene efficacy of a novel herbal toothpaste with zinc over a 6-month period.

OBJECTIVES: This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, that is, clove (Syzgium Aromaticum), aloe vera (Aloe Barbadensis), amla (Emblica Officinalis), neem (Azadirachta Indica), tulsi (Ocimum Basillicum) and honey (from Apis Mellifera) along with zinc salts and fluoride in comparison with a dentifrice formulated with fluoride alone on dental plaque and gingivitis over a 6-month period. MATERIALS AND METHOD: One hundred and eighty (180) subjects with mean plaque index scores greater than 1.5 (Turesky Modified Quigley Hein Plaque Index) and gingival index scores >1.0 (Loe and Silness gingival index) in good general health and who met other study criteria were enrolled in the clinical study. Subjects were evaluated for plaque and gingival index scores and were randomly assigned to perform twice-daily oral hygiene with either the test or the control toothpaste for the next 6 months. One hundred and fifty (150) subjects [test toothpaste (n = 72) and control toothpaste (n = 78)] completed the 6-month clinical study with evaluable data. Post-treatment assessments identical to baseline were conducted after 3-month and 6-month use of an assigned product after subjects refrained from oral hygiene for 12 h prior to each evaluation. Comparisons of the treatment groups with respect to baseline-adjusted gingival, plaque, and bleeding index scores at the follow-up examinations were performed using analyses of covariance (ANCOVA). All statistical tests of hypotheses were two-sided and employed a level of significance of p < 0.05. RESULTS: No significant intergroup differences were noted between treatment groups for age and gender by two-sample t-test and chi-square analyses, respectively (p > 0.05). Furthermore, the treatment groups demonstrated no differences at baseline for plaque, gingival and bleeding index scores by a two-sample t-test (p > 0.05). At 3-month and 6-month examination, the test toothpaste exhibited progressive reductions in plaque, gingival and bleeding scores as compared to control toothpaste as showed by ANCOVA (p < 0.001). In comparison with the control, the test demonstrated reductions in 23.5%, 25.6%, and 73.3% for dental plaque, gingival index and bleeding index outcomes, respectively, at the final visit. Reductions in the frequencies of sites with higher clinical scores were noted over the study with more sites registering improvements in the test group than in the control group. CONCLUSIONS: Routine oral hygiene with the test toothpaste formulated with herbal ingredients and zinc demonstrated a clinical adjunctive improvement in oral hygiene and parameters of gingival health as compared to brushing with a fluoride toothpaste.

Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: A randomized clinical study.

AIM: To compare efficacy of an anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control) for dentine hypersensitivity relief after 8 weeks' twice-daily use. MATERIALS AND METHODS: In this randomized, examiner-blind, stratified, parallel study, primary and secondary efficacy variables were mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe), respectively, from baseline to Week 8 between Test (n = 62) and Negative control (n = 62). Test and Positive control (n = 61) comparisons were exploratory objectives. RESULTS: All groups significantly improved from baseline on both dentine hypersensitivity measures (p < .0001). Difference between adjusted mean changes from baseline in Schiff sensitivity scores at Week 8 for Test versus Negative control groups was 0.19 (95% CI 0.002, 0.374), in favour of the Negative control (p = .0476; 12.57% difference). Difference in tactile threshold was -7.20 g (95% CI -16.376, 1.975), and this was not statistically significant (p = .3715; -21.83% difference). Test group showed no significant difference versus Positive control for either measure. Toothpastes were generally well tolerated. CONCLUSION: While twice-daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls. STUDY REGISTRATION: Clinicaltrials.gov; NCT03310268.

Root caries lesions inhibition and repair using commercial high-fluoride toothpastes with or without tri-calcium phosphate and conventional toothpastes containing or not 1.5% arginine CaCO3: an in situ investigation.

OBJECTIVES: This double-blind, crossover, and in situ study evaluated the effect of commercial high-F toothpastes with or without functionalized ß-tri-calcium phosphate (fTCP) and conventional-F toothpaste containing or not 1.5% arginine-CaCO3 in preventing and repairing root caries-like lesions. METHODS: Twelve volunteers wore palatal appliances containing sound (S) and pre-demineralized (PD) bovine root dentin blocks in 4 phases of 14 days/each. They used F toothpastes, 3×/day: (i) 1,450 µg F/g (conventional-F); (ii) 1,450 µg F/g + 1.5% arginine-CaCO3 (conventional-F + arginine/CaCO3); (iii) 5,000 µg F/g (high-F); and (iv) 5,000 µg F/g (high-F + fTCP). Sucrose solution (20%) was dropped 8×/day on the S blocks. The demineralization in the S blocks and the remineralization in the PD ones were estimated by % of surface hardness difference (%SH-S) and % of SH recovery (%SHR-PD), respectively. Caries lesion area (ΔS) was determined in the blocks. Statistical analyses were performed by one-way ANOVA/Kruskal-Wallis and multiple comparisons tests (p < 0.05). RESULTS: Both high-F toothpastes presented similar effect to prevent early caries lesions and it was higher than conventional-F + arginine/CaCO3. All treatments resulted in significantly lower ΔS values compared with conventional-F toothpaste (p < 0.0001). High-F + fTCP showed non-significantly higher preventive and reversible effect compared to high-F. The effect of conventional-F + arginine/CaCO3 was similar to high-F and lower than high-F + fTCP in preventing and reverting in-deep caries lesions. CONCLUSIONS: Overall, high-F toothpastes seem to be more effective and interesting feasible strategy for both prevention and remineralization actions in root dentin. CLINICAL RELEVANCE: With the trend of increasing dentin root caries, this study brings new evidences about the preventive and repair effect of high-F toothpastes with or without fTCP in root caries and support the use of arginine in toothpastes.

Gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice: a 24-week randomized controlled trial.

BACKGROUND: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis and the proportion of subjects moving between gingivitis severity (< 10, > 10 < 30, > 30% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks. METHOD: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High > 2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 h prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores. RESULTS: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p < 0.0001). At 24 weeks, 71% of subjects in the 0.453% SnF2 treatment group demonstrated < 10% of bleeding sites. CONCLUSION: A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of "clinical periodontal health" (< 10%) following a dental prophylaxis and 24 weeks of product use. TRIAL REGISTRATION: This study was retrospectively registered at ClinicalTrials.gov, on 11th Oct. 2019 (NCT04123665).

In situ efficacy of an experimental toothpaste on enamel rehardening and prevention of demineralisation: a randomised, controlled trial.

BACKGROUND: A novel sodium fluoride toothpaste containing lactate ion and polyvinylmethylether-maleic anhydride has been developed to promote enamel remineralisation and resistance to demineralisation. In this in situ study, we compared this toothpaste ('Test') with a stannous fluoride-zinc citrate (SnF2-Zn) toothpaste ('Reference') (both 1100-1150 ppm fluoride) and a fluoride-free toothpaste ('Placebo') using an enamel dental erosion-rehardening model. METHODS: In each phase of this randomised, investigator-blind, crossover study, participants wore palatal appliances holding bovine enamel specimens with erosive lesions. They brushed their natural teeth with either the Test, Reference or Placebo toothpastes, then swished the resultant slurry. Specimens were removed at 2 h and 4 h post-brushing and exposed to an in vitro acid challenge. Surface microhardness was measured at each stage; enamel fluoride uptake was measured after in situ rehardening. Surface microhardness recovery, relative erosion resistance, enamel fluoride uptake and acid resistance ratio were calculated at both timepoints. RESULTS: Sixty two randomised participants completed the study. Test toothpaste treatment yielded significantly greater surface microhardness recovery, relative erosion resistance and enamel fluoride uptake values than either Reference or Placebo toothpastes after 2 and 4 h. The acid resistance ratio value for Test toothpaste was significantly greater than either of the other treatments after 2 h; after 4 h, it was significantly greater versus Placebo only. No treatment-related adverse events were reported. CONCLUSIONS: In this in situ model, the novel-formulation sodium fluoride toothpaste enhanced enamel rehardening and overall protection against demineralisation compared with a fluoride-free toothpaste and a marketed SnF2-Zn toothpaste. TRIAL REGISTRATION: ClinicalTrials.gov; NCT03296072; registered September 28, 2017.

What is the effect of active ingredients in dentifrice on inhibiting the regrowth of overnight plaque? A systematic review.

OBJECTIVES: The aim of this systematic review was to establish the adjuvant clinical effect of brushing with a dentifrice containing purported active ingredients as compared to a regular sodium fluoride dentifrice with respect to the inhibition of overnight dental plaque regrowth from studies with human participants. METHODS: MEDLINE-PubMed, EMBASE and Cochrane CENTRAL were searched, up to June 2019. The inclusion criteria were controlled clinical trials with participants aged ≥ 18 years in good general health. Studies were included that evaluated the effect of toothbrushing with a dentifrice on the inhibition of overnight dental plaque regrowth when an active ingredient was added to the dentifrice as compared to a common sodium fluoride product. Data were extracted from the eligible studies, the risk of bias was assessed, and a meta-analysis was performed where feasible. RESULT: Independent screening of 213 unique papers resulted in 10 eligible publications that provided 14 comparisons. Stannous fluoride and triclosan dentifrices were found as the active ingredients. The descriptive analysis indicated that all, but two comparisons demonstrated an additional effect on the active-ingredient dentifrice. The meta-analysis supported and strengthened these findings. It showed that when plaque was scored digitally, a DiffM was -3.15(95% CI [-4.61:-1.69], P < .001, prediction interval [-5.07;-1.24]). When plaque was scored clinically, the difference of means (DiffM) was -0.33(95% CI [-0.49:-0.16], P < .001, prediction interval [-0.87; 0.21]). CONCLUSION: The results of this review demonstrate moderate-quality evidence that brushing with an active-ingredient dentifrice with stannous fluoride or triclosan does provide an added clinically relevant effect concerning plaque inhibition capabilities that surpass the effect of a regular sodium fluoride dentifrice.