An exploratory study to investigate stain build-up with long term use of a stannous fluoride dentifrice.

PURPOSE: To monitor extrinsic stain formation over 24 weeks with twice-daily use of an anhydrous 0.454% SnF2 dentifrice containing 5% sodium tripolyphosphate (STP) ('Test'), compared to a standard fluoride dentifrice (0.76% fluoride as sodium monofluorophosphate [SMFP\) ('Comparator') following a professional prophylaxis. METHODS: Primary efficacy variables were between-treatment differences in extrinsic dental stain of anterior teeth after 4, 8, 12, and 24 weeks' use using mean area and intensity scores of the MacPherson modification of the Lobene stain index (MLSI), and to monitor oral tolerability. RESULTS: Overall, 214 subjects were randomized to treatment. The Test dentifrice group demonstrated statistically significantly less stain compared with the Comparator at each timepoint for all outcome variables (MLSI - Area × Intensity, Area only, and Intensity only) with the exception of MLSI (Area × Intensity) at Week 12. Products were generally well tolerated with 26 treatment-related adverse events (TRAEs) reported (10 with Test, 16 with Comparator). Five subjects withdrew from the 24-week study due to TRAEs, three in the Test group, two in the Comparator group. Statistically significantly less anterior tooth staining was observed with up to 24 weeks twice-daily brushing with a 0.454% SnF2/5% STP anhydrous dentifrice compared to a marketed fluoride dentifrice with 0.76% SMFP. CLINICAL SIGNIFICANCE: Long term use of a SnF2/STP dentifrice demonstrated minimal stain build-up after 24 weeks, twice-daily use; products were generally well-tolerated.

A randomized clinical study investigating the staining profile of an experimental stannous fluoride dentifrice.

PURPOSE: The primary objective of this study was to investigate the staining profile of an experimental test dentifrice containing 0.454% w/w stannous fluoride compared to that of a marketed control dentifrice containing 0.76% w/w sodium monofluorophosphate (Colgate Cavity Protection) following regular and repeat use, with twice daily brushing over 8 weeks. As an exploratory objective, the staining profile of the test dentifrice was compared to that of a marketed comparator dentifrice containing 0.454% w/w stannous fluoride (Crest Pro-Health - Clean Mint). METHODS: This was a single-center, examiner-blind, randomized, three arm, parallel group study, stratified by pre-baseline stain score [total Lobene Stain Index (LSI) (area x intensity) score < 31, > or = 31] and smoking status. Following initial screening, 137 healthy subjects, aged 18 years and above, with 12 gradable anterior teeth returned for baseline assessments. At the baseline visit, subjects received an oral soft tissue (OST) examination and an assessment of extrinsic dental stain using the LSI on the facial and lingual surfaces of the 12 anterior teeth, LSI area, LSI intensity and LSI area x intensity (the LSI area x intensity score was termed the pre-baseline LSI score). Subjects who met study requirements received a dental prophylaxis of the anterior teeth to remove all visible stain from their tooth surfaces such that an LSI (area x intensity) score of 0 was achieved. Randomized subjects brushed with their assigned dentifrice at home twice daily for 1 timed minute and returned after 4 and 8 weeks for an OST examination and dental stain assessment of the anterior teeth using LSI. RESULTS: There were no statistically significant differences in dental stain build-up between the test dentifrice containing 0.454% w/w stannous fluoride and a marketed control dentifrice (Colgate Cavity Protection), after 4 and 8 weeks of twice daily brushing, in terms of LSI area x intensity, LSI area or LSI intensity scores. Exploratory analysis indicated that the marketed stannous fluoride dentifrice (Crest Pro-Health) exhibited more dental stain build-up at 4 and/or 8 weeks compared to the other two study dentifrices. However, post-hoc analysis revealed an imbalance in LSI baseline stain levels between the treatment groups, with higher stain levels in the marketed comparator group, which made it difficult to draw robust conclusions from the exploratory data. This imbalance was not considered to impact the other study analyses. Study treatments were well tolerated.

In vitro reproduction of incisal/occlusal cupping/cratering.

STATEMENT OF PROBLEM: Occlusal cupping/cratering (depressed dentin surrounded by elevated rims of enamel) has been postulated to be the result of abrasion, bruxism, attrition, acid erosion, stress corrosion, or a combination of these. The primary etiology or the multifactorial sequence of occlusal cupping/cratering remains scientifically unsubstantiated. PURPOSE: The purpose of this study was to reproduce occlusal/incisal cupping/cratering in vitro. This study was designed to create cupping/cratering on the occlusal surfaces of extracted human teeth rather than to quantify the amount of lost tooth structure caused by abrasion. MATERIAL AND METHODS: One name-brand toothbrush was tested with 2 different dentifrices (of different abrasive potentials [low and high]) and water only (nonabrasive) on extracted human teeth. Six specimens of 4 teeth each (24 teeth) were subjected to horizontal brushing in a 1:1 toothpaste/water slurry and water only. RESULTS: The control group, brushed with water only, demonstrated no visible loss of tooth structure. Each of the specimens brushed with toothpaste, regardless of the degree of abrasivity, demonstrated visible wear of the dentin, resulting in occlusal/incisal cupping/cratering. CONCLUSIONS: Pronounced cupping/cratering was caused by horizontal brushing with commercial toothpastes. Brushing in water demonstrated no visual loss of occlusal tooth structure. (J Prosthet Dent 2013;109:384-391).

A randomised crossover trial to compare the potential of stannous fluoride and essential oil mouth rinses to induce tooth and tongue staining.

This study compared the staining potential of two experimental amine fluoride/stannous fluoride mouth rinses (A and B), a phenolic/essential oil rinse (C) and a negative control, water, rinse (D). The study was a single centre, randomized, single-blind, four treatment crossover study design among healthy participants. Prior to each study period, participants received a dental prophylaxis. On the Monday of each period, subjects suspended oral hygiene, and under supervision, rinsed with the allocated mouth rinse immediately followed by a warm black tea solution at hourly intervals eight times a day for 4 days. On Friday, the area and intensity of staining on the teeth, the primary outcome measure and dorsum of tongue were assessed. This regimen was repeated for all the three subsequent treatment periods. Rinse B produced less stain than rinse A, but the difference was not significant (p = 0.20). Rinse B produced significantly more stain than rinse C (p < 0.05) and D (p < 0.001). For tongue staining, rinse B produced significantly more staining than D (p < 0.01) but not A or C. Overall, all test rinses produced more staining than placebo with an overall pattern for more staining with stannous formulations. Individuals using stannous or phenolic/essential oil mouth rinse formulations should be advised of the possible staining side effect and that this can be easily removed by a professional dental cleaning.

In situ randomised trial investigating abrasive effects of two desensitising toothpastes on dentine with acidic challenge prior to brushing.

OBJECTIVES: To determine if brushing dentine with 2 moderate RDA desensitising toothpastes, results in a significant dentine wear difference and whether this difference continues to be relevant when preceded with an erosive challenge. METHODS: An in situ, single centre, single blind, randomised, split mouth study, evaluated the difference in abrasion of 2 toothpastes (SFM - Sensodyne Fresh Mint(®) RDA 70; CPHM - Crest Pro-Health Clean Mint(®) RDA 120) in 28 healthy volunteers. Two toothpaste treatments were administered 3×/day, for each of the two 15 day periods, subjects wearing bi-lateral, lower buccal appliances each with 4 dentine sections. A 2 min extra-oral acidic challenge preceded toothbrushing for 2 study arms. Contact profilometry measured samples at baseline, days 5, 10 and 15. RESULTS: Brushing with SFM was significantly less abrasive than brushing with CPHM at all time points, with or without a preceding acidic challenge (p<0.0001). The additional dentine loss arising from the erosive challenge prior to brushing with each paste was linear with time and independent of abrasive effect. CONCLUSIONS: The desensiting toothpastes' RDA, directly related to dentine loss with toothbrushing. An acidic challenge prior to brushing did not negate the benefits of reduced wear from the lower RDA paste compared to the higher RDA paste. When brushing eroded dentine, the additional wear appeared independent of abrasive effect. Dentine hypersensitivity sufferers should be recommended to use a low-moderate RDA toothpaste, not to brush more than 2×/day and not immediately following an acidic challenge.

Investigation on the clinical efficacy and tolerability of a 0.4% topical stannous fluoride preparation (MedEquine Gel) for the treatment of bacterial skin infections in horses: a prospective, randomized, double-blinded, placebo-controlled clinical trial.

The purpose of this prospective, double-blinded, placebo-controlled clinical trial was to investigate the efficacy and tolerability of a novel gel containing 0.4% stannous fluoride (MedEquine) for the treatment of cutaneous bacterial infections in horses. Twenty privately owned horses diagnosed with bacterial skin infections based on physical findings and cytology results were enrolled and randomly assigned to either a placebo or an active ingredient treatment group. The product was applied on affected areas daily for 4 weeks. Cytology and clinical evaluations were done by the same investigator at the beginning and at the end of the treatment. Owners scored pruritus weekly. Both owners and investigators were blinded to the allocation to the groups. At the end of the study, stannous fluoride gel treatment significantly decreased the investigator's clinical scores and owners' pruritus scores while no significant changes were detected in the vehicle treatment group. At the end of the trial, none of the horses in the stannous fluoride group required additional therapy while four of ten horses in the vehicle group required systemic therapy to resolve the infection. No adverse effects were detected in any of the groups. The gel formulation made compliance easier for owners compared to the traditional bathing regimen and allowed spot treatment, which was particularly helpful in animals with localized infections. These favourable aspects of the treatment were highlighted by the owners of the horses enrolled in the study. In conclusion, 0.4% stannous fluoride gel (MedEquine) was an effective and safe therapy for the topical management of bacterial skin infections in the horses included in the study.

The effect of a dentifrice and mouth rinse combination containing amine fluoride/stannous fluoride on plaque and gingivitis: a 6-month field study.

AIM: To examine the effect of amine fluoride/stannous fluoride (AmF/SnF(2))-containing dentifrice and mouth rinse on plaque formation and gingivitis as compared with habitual oral hygiene procedures with a regular sodium fluoride (NaF) dentifrice. MATERIAL AND METHODS: In total, 22 general practices participated in this research project. The participants (N=281) were randomly assigned into two groups: the test group received an AmF/SnF(2) dentifrice-mouth rinse combination and the control group received a NaF-containing dentifrice. The patients were requested to brush twice daily for approximately 2 min. The subjects of the test group had to rinse additionally in the evening for 30 s with 10 ml of the mouth rinse. RESULTS: Both groups started with comparable scores of plaque, bleeding and staining. At 6 months, the plaque scores were 0.95 for the AmF/SnF(2) group and 0.99 for the NaF group (decrease of 16% and 10%, respectively). Bleeding scores, although significantly different from baseline, did not show differences between the two regimes. At the end of the experimental period, the overall staining was more pronounced in the AmF/SnF(2) group (41%) than the NaF group (26%). Both plaque reduction and increase in staining seemed to be correlated to the amount of mouth rinse used in the test group. CONCLUSION: In instruction-resistant patients recruited from dental practices, the combined use of AmF/SnF(2) did not decrease gingivitis at a significant level in comparison with the regular regime of two times daily brushing with an NaF-containing dentifrice. However, the above-mentioned combination resulted in greater plaque reduction than that observed with the use of the conventional dentifrice. When used according to the manufacturer's instructions, this effect on plaque scores was more pronounced.

Evaluation of additional amine fluoride/stannous fluoride-containing mouthrinse during supportive therapy in patients with generalized aggressive periodontitis. A randomized, crossover, double-blind, controlled trial.

OBJECTIVES: The objective of the present randomized controlled trial was to evaluate the efficacy of a mouthrinse containing a combination of AmF/SnF2 in controlling supragingival plaque accumulation and gingival inflammation during a 12-week period in patients affected by generalized aggressive periodontitis (GAP). METHODS: Eighteen subjects, six males and 12 females, mean age: 32.2 years, were evaluated. One-half of the patients was either prescribed an AmF/SnF2-containing mouthrinse (test mouthrinse) or a control mouthrinse in addition to mechanical plaque control for 12 weeks. After a 2-week wash-out period, the patients received the alternative mouthrinse. Before and after treatment plaque index (PlI), gingival index (GI), angulated bleeding index (AngBI), tooth stain (GMSI), and tongue stain were recorded. RESULTS: Test mouthrinse resulted in a statistically significant decrease in PlI (p = 0.029) and GI (p = 0.017). After treatment, PlI was significantly lower in test compared to control mouthrinse (p = 0.027). GMSI significantly increased post-treatment for both mouthrinse regimens (p < 0.001), a significantly higher score being observed for the test compared to control mouthrinse (p = 0.002). CONCLUSIONS: The 12-week use of a AmF/SnF2-containing mouthrinse as an adjunct to conventional mechanical oral hygiene procedures in GAP patients was effective in controlling the amount of supragingival plaque deposits.

Comparison of two dentifrices with respect to efficacy for the control of plaque and gingivitis, and with respect to extrinsic tooth staining: a six-month clinical study on adults.

The objective of this six-month, double-blind clinical study, conducted in harmony with American Dental Association guidelines, was to provide a comparison between Colgate Total Toothpaste and Crest Gum Care Toothpaste with respect to their levels of efficacy for the control of supragingival dental plaque and gingivitis, and with respect to the levels of tooth staining associated with their use. Adult male and female subjects from the Edinburgh, Scotland area were entered into the study and stratified into two treatment groups which were balanced for age, sex, baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Subjects received an oral prophylaxis, and were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for plaque, gingivitis and extrinsic tooth staining were conducted after three months' and again after six months' use of the study dentifrices. One-hundred and nine (109) subjects complied with the protocol and completed the entire six-month clinical study. At both the three- and six-month study examinations, the Colgate Total Toothpaste group exhibited statistically significantly less plaque, gingivitis and extrinsic tooth staining compared to the Crest Gum Care Toothpaste group. At the six-month examination, the magnitude of these differences exceeded 18% for all six parameters measured (18.7% for Plaque Index, 60.5% for Plaque Severity Index, 22.2% for Gingival Index, 85.1% for Gingivitis Severity Index, 45.3% for stain intensity, and 46.3% for stain area). Thus, the results of this six-month clinical study support the conclusion that Colgate Total Toothpaste provides a statistically significant, substantive advantage in efficacy for the control of plaque and gingivitis over Crest Gum Care Toothpaste, while, at the same time, providing better control against the development of extrinsic tooth staining.

Clinical study to compare extrinsic stain formation in subjects using three dentifrice formulations.

The purpose of this study was to compare the degree of extrinsic dental stain formed with the use of three dentifrices: (1) a new dentifrice formulation containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.); (2) a commercially available dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.); and (3) a dentifrice containing 0.243% sodium fluoride in a silica base (Colgate Winterfresh Gel, Colgate-Palmolive Co.). A total of 121 participants were entered into the study and stratified into 3 balanced groups according to baseline mean Lobene Stain Index scores. A thorough dental prophylaxis was completed on each participant after completion of the baseline examination. The three groups were randomly assigned to use one of the three dentifrices. The groups were well balanced with regard to mean baseline stain index scores, gender, and tobacco habits. Participants were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Extrinsic dental stain examinations, which measured dental stain area and dental stain intensity, were conducted at baseline and 4 and 8 weeks. Examinations were conducted by the same dental examiner at each examination. After 4 and 8 weeks' use of the test dentifrices, there was no statistically significant difference regarding extrinsic stain formation with the use of any of the dentifrices. Thus, it can be concluded from this study that the use of a new formulation dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base will not result in a greater formation of extrinsic dental staining than that which is formed by two commercially available dentifrices not known to cause extrinsic dental stain.

Tissue necrosis after subgingival irrigation with fluoride solution.

Irrigation of periodontal pockets with fluoride solution after scaling and root planing is occasionally recommended to inhibit the growth of pathogenic bacteria in the periodontal pocket. At the same time, irrigation enables mechanical removal of loosely adhering plaque and debris. Due to its toxicity, fluoride solution deposited in the periodontium may lead to tissue damage. We report in this paper, a case of extensive periodontal tissue necrosis and permanent loss of alveolar bone after irrigation of periodontal pockets with stannous fluoride solution. The literature on the toxic effects of fluoride on the local tissues is briefly reviewed and arguments for a re-evaluation of the use of stannous fluoride for pocket irrigation are provided.

Comparative antiplaque effectiveness of an essential oil and an amine fluoride/stannous fluoride mouthrinse.

The adjunctive use of antimicrobial mouthrinses to help control supragingival plaque and gingivitis has been shown to contribute significantly to patients' daily oral hygiene regimens. This controlled clinical study used an observer-blind, randomized, cross-over design in a 4-day plaque regrowth model to determine the relative efficacies of an essential oil-containing mouthrinse (Listerine Antiseptic) and an amine fluoride/stannous fluoride-containing mouthrinse (Meridol) in inhibiting the development of supragingival plaque. A 0.1% chlorhexidine mouthrinse (Chlorhexamed-Fluid) was used as a positive control, and a 5% hydroalcohol solution was used as a negative control. Dosing for each of the test mouthrinses was based on the manufacturers' label directions. Because the volume and rinse time for each of the test mouthrinses were different, each test mouthrinse had its own negative control group. On day 1 of each test period, subjects received an oral soft and hard tissue examination and a dental prophylaxis to remove all plaque, calculus, and extrinsic stain. Starting the same day, subjects refrained from all mechanical oral hygiene procedures for the next 4 days and rinsed 2x daily under supervision with their randomly-assigned mouthrinse. On day 5, each subject received a plaque assessment as well as an oral examination to assess side effects. Each test period was separated by a 2-week washout period. 23 volunteers with a median age of 26 years completed the study. Compared to the respective placebos, the median percent plaque reductions at 5 days were 23.0%, 12.2%, and 38.2% for the essential oil, amine/stannous fluoride, and chlorhexidine rinses, respectively. The plaque reductions seen in the essential oil and chlorhexidine rinse groups were statistically significant (p < 0.001), while the plaque reduction in the amine/stannous fluoride rinse group was not statistically significant (p > 0.05). Additionally, the essential oil rinse was significantly more effective (p < 0.001) than the amine/stannous fluoride rinse in inhibiting plaque accumulation in this clinical model.

Acute fluoride toxicity from ingesting home-use dental products in children, birth to 6 years of age.

OBJECTIVE: This paper analyzes reports to the American Association of Poison Control Centers (AAPCC) of suspected overingestion of fluoride by children younger than 6 years of age between 1989 and 1994, and estimates the probably toxic amounts of various home-use fluoride products in children younger than 6 years of age. METHODS: Annual incidence rates of reported fluoride exposures attributed to dietary supplements, toothpaste, and rinses were calculated. Probably toxic amounts of each product were calculated using the frequently cited dose of 5 mg/kg. RESULTS: Children younger than 6 years of age accounted for more than 80 percent of reports of suspected overingestion. While the outcomes were generally not serious, several hundred children were treated at health care facilities each year. A 10 kg child who ingests 50 mg fluoride (10.1 g 1.1% NaF gel; 32.7 g 0.63% SnF2 gel; 33.3 g 1,500 ppm F toothpaste; 50 g 1,000 ppm F toothpaste; and 221 mL 0.05% NaF rinse) will have ingested a probably toxic dose. CONCLUSIONS: Overingestion of fluoride products in the home is preventable. Dentists and other health care providers should educate parents and child care providers about the importance of keeping fluoride products out of reach of children. Manufacturers should be encouraged by the ADA and the FDA to use child-resistant packaging for all fluoride products intended for use in the home.

Studies on stannous fluoride toothpaste and gel (1). Antimicrobial properties and staining potential in vitro.

Stannous fluoride (SF) in a toothpaste vehicle has the potential to provide anticaries and plaque inhibitory benefits through the fluoride and antimicrobial stannous moieties respectively. Dental staining, however, can occur by precipitation of dietary chromogens onto the tooth surface by stannous ions. These studies in vitro compare the antimicrobial profile and propensity to cause tea staining of a number of stannous fluoride formulations. The formulations used were 2 SF toothpaste products (SF1, SF2), 2 experimental SF plus stannous pyrophosphate toothpastes (SFSP1, SFSP2), a SF gel (G) and a NaF toothpaste (C). Maximum inhibitory dilution values against a range of oral bacteria were determined by agar dilution. Tea staining was measured spectrophotometrically on saliva coated clear acrylic blocks exposed to slurries of the paste or gel. All formulations showed antimicrobial activity with the order of greatest activity downwards being C, SF2, SF1, SFSP1, SFSP2 and G. Tea staining at 10 exposures was in the following descending order of optical density SFSP1, SFSP2, G. C, SF1, SF2, water control. The antimicrobial profile of G was similar to that of SF, whereas that of the other formulations were varied but similar to a detergent profile. The difference in staining suggested considerable variation in availability of stannous ions in the formulations. However, the propensity for stannous ions to stain must be balanced against the stain removal propensity of the contained detergents in the toothpaste formulations. In conclusion, the variation in antimicrobial activity and more particularly staining activity of the formulations suggest the products will vary in activity in vivo.