Efficacy and safety of a novel stabilized stannous fluoride and sodium hexametaphosphate dentifrice for dentinal hypersensitivity

PURPOSE: Dentinal hypersensitivity is a common complaint among dental patients. Recently, a novel 0.454% stabilized stannous fluoride dentifrice containing sodium hexametaphosphate (SHMP) was introduced that offers a desensitizing benefit. This trial was conducted to assess the desensitizing efficacy of this new dentifrice relative to a sodium fluoride control dentifrice. METHODS AND MATERIAL: This was a double-blind, parallel-group, randomized clinical trial conducted according to the American Dental Association (ADA) Guidelines for the Acceptance of Products for the Treatment of Dentinal Hypersensitivity. Ninety subjects who met the entrance criteria were stratified based on age, gender, and baseline sensitivity scores and randomly assigned to either the stabilized stannous fluoride + SHMP dentifrice (Crest Pro-Health) or the sodium fluoride control dentifrice. Subjects were instructed to brush twice daily for eight weeks. Efficacy assessments were made, including tactile (Yeaple probe) and thermal (Schiff Air Index) sensitivity, and an oral soft tissue examination was conducted at baseline, week four, and week eight. RESULTS: The mean sensitivity score based on the Schiff Air Index for the stannous fluoride + SHMP group was statistically significantly lower than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had an adjusted mean 44% lower than that of the control group. The mean tactile sensitivity score for the stannous fluoride + SHMP group was statistically significantly higher, indicating a reduction in sensitivity, than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had a mean desensitizing improvement of 71% greater than the control. CONCLUSION: The stabilized stannous fluoride + SHMP dentifrice provided statistically significant reductions in dentinal hypersensitivity at four and eight weeks compared to the sodium fluoride control dentifrice.     

Potassium oxalate mouthrinse reduces dentinal hypersensitivity: A randomized controlled clinical study

Background

Dentinal hypersensitivity is a prevalent oral condition that can be treated with in-office application of potassium oxalate (KO), which has US Food and Drug Administration 510(k) clearance. In this study, the authors assessed a KO mouthrinse for home use. The authors evaluated clinically meaningful improvement by analyzing the proportions of participants who responded to treatment.

A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis

OBJECTIVES: This study was conducted to assess anti-plaque and anti-gingivitis benefits of a stabilized stannous fluoride (SnF(2))/sodium hexametaphosphate (SHMP) dentifrice versus a negative control. MATERIAL AND METHODS: This was a randomized, 6-month, stratified, single-centre, double-blind, parallel group, clinical study conducted in harmony with the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% SnF(2)/SHMP dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were instructed to brush twice daily for 60 s using their assigned product. Efficacy measurements were obtained at baseline, 3 and 6 months post treatment using the Modified Gingival Index, Gingival Bleeding Index and the Turesky Modified Quigley-Hein Plaque Index. Oral tissue examinations were performed at all visits. Results: A total of 140 subjects were enroled and 128 completed the study. RESULTS after 6 months showed the SnF(2) dentifrice delivered a 16.9% reduction in gingivitis (p<0.001), a 40.8% reduction (p<0.001) in gingival bleeding, and an 8.5% reduction in plaque (p=0.001) versus the negative control. Both treatments were well tolerated. CONCLUSIONS: Twice daily use of the SnF(2)/SHMP dentifrice over 6 months provided statistically significant anti-plaque and anti-gingivitis benefits relative to a negative control.     

Comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the prevention of periodontitis in xerostomic patients: a 2-year randomized clinical trial

BACKGROUND: The primary objective of this study was to compare the efficacy of a stannous fluoride (SnF2) dentifrice relative to a positive control triclosan dentifrice for prevention of clinical attachment loss (CAL) in xerostomic patients. A secondary objective was to compare the dentifrices for root caries remineralization. METHODS: This was a 2-year, randomized, double-masked, parallel-group study. A 0.454% SnF2/sodium hexametaphosphate dentifrice was tested versus a positive control dentifrice (sodium fluoride/0.30% triclosan/copolymer) in 440 medication-induced xerostomic adults identified in a 1-year, run-in phase (no treatment) as high risk for periodontitis and root caries. During the study phase, subjects were stratified based on gender and attachment level into two groups. Subjects brushed twice a day for 60 seconds using their assigned product. Clinical examinations including probing depth, attachment level, bleeding on probing, and root caries remineralization were performed at baseline and 1 and 2 years. RESULTS: A total of 334 subjects were evaluable. During run-in, average CAL relative to initial examination was 1.33 mm. Probing depth increased 0.95 mm. At year 2 in the treatment phase, attachment gain was 0.77 mm for the test group and 0.79 mm for the control group versus baseline. Probing depth decreased 0.57 mm for the test group, similar to the control group (0.53 mm). These changes versus baseline were statistically significant (P <0.01) for each group. Products were not statistically significantly different from each other. Both treatments resulted in similar remineralization for root caries lesions at study completion (P = 0.40). CONCLUSION: The results establish comparable benefits for the SnF2 dentifrice in preventing CAL and root caries versus the sodium fluoride/triclosan/copolymer control in xerostomic patients.     

A dentifrice containing potassium nitrate,stannous fluoride,and sodium fluoride is effective at reducing root sensitivity

J Evid Base Dent Pract 2002;2:227-8     

Extrinsic stain removal efficacy of a stannous fluoride dentifrice with sodium hexametaphosphate

OBJECTIVE: Two randomized, six-week, double-blind, parallel group, clinical trials were independently conducted to compare the extrinsic stain removal efficacy of a novel whitening therapeutic dentifrice containing 0.454% stannous fluoride and sodium hexametaphosphate in a formulation with high cleaning silica, relative to a positive control whitening dentifrice. METHODOLOGY: Generally healthy adults, 56 for study 1 and 60 for study 2, with visible extrinsic tooth stain were enrolled in the studies. At the baseline visit, stain was assessed on the facial surfaces of the eight central and lateral incisors using the modified Lobene Stain Index. Oral soft and hard tissue examinations were also conducted. In each study, subjects were randomized to either the stannous fluoride + sodium hexametaphosphate toothpaste (Crest Pro-Health) or the positive control toothpaste (Colgate Total Plus Whitening) to use twice per day for six weeks. Stain and safety were reassessed at weeks three and six. RESULTS: Fifty-two and 58 subjects completed studies 1 and 2, respectively. In each study, there were no statistically significant differences in Lobene composite stain scores between the two treatment groups across all three visits. Both groups showed statistically significant reductions in Lobene composite stain scores at week three (p < 0.0001) and week six (p < 0.0001) relative to baseline. The percent of Lobene composite scores with a greater than 0.5 unit reduction from baseline at week six was 86% for study 1 and 97% for study 2 for the stannous fluoride + sodium hexametaphosphate dentifrice group. CONCLUSION: Collectively, these two stain removal clinical trials demonstrate the statistically significant extrinsic stain removal efficacy for the stannous fluoride + sodium hexametaphosphate dentifrice relative to baseline. There were no statistically significant differences between the stannous fluoride + sodium hexametaphosphate dentifrice and positive control treatment group.     

The comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the control of gingivitis: a 6-month randomized clinical study

BACKGROUND: Antimicrobial agents such as stannous fluoride and triclosan have been incorporated into dentifrice formulations and have been shown to be effective in reducing gingivitis. The objective of this study was to compare the anti-gingivitis efficacy of a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice to a positive control triclosan/copolymer dentifrice. METHODS: This was a 6-month, randomized, double-masked, parallel-group study conducted according to the American Dental Association guidelines for evaluating chemotherapeutic products for the control of gingivitis. A 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available positive control dentifrice (0.30% triclosan/2.0% Gantrez copolymer). Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 seconds using their assigned product. Tooth brushing was supervised for 3 days of each week. Clinical examinations using a gingival index were performed at baseline and at 3 and 6 months. RESULTS: A total of 199 subjects were enrolled and 186 completed the 6-month study. Average baseline gingivitis and bleeding scores were similar for the two treatment groups. After 6 months, the experimental group had statistically significantly less gingivitis (25.8%) and statistically significantly less bleeding (27.4%) on average compared to the control group. Neither adverse oral soft tissue effects nor tooth staining were reported. CONCLUSION: Within the limits of the study protocol, the results demonstrated superior therapeutic benefits for the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice in reducing gingivitis compared to the triclosan/copolymer control in this partially supervised study.     

Clinical evaluation of a potassium nitrate dentifrice for the treatment of dentinal hypersensitivity

Abstract The effectiveness of a 5% potassium nitrate dentifrice as a daily home treatment for dentinal hypersensitivity was evaluated in a double-blind study in 36 Japanese subjects who complained of cold and/or tactile hypersensitivity. The subjects were divided into 2 groups, with 18 being given a 5% potassium nitrate dentifrice (treated group) and the other 18 a vehicle paste (control group). Both groups were instructed to brush their teeth 2 × a day. The hypersensitivity levels of the affected teeth were assessed by 2 stimuli, one tactile and the other cold air, and by the perception of pain. The results of all 3 assessment methods indicated that the potassium nitrate dentifrice significantly decreased the level of hypersensitivity at weeks 4, 8, and 12. In the treated group, a rapid decrease of positive scores for both the cold air stimulus and the subjective symptoms appeared from week 2. Although a significant decrease of the assessment score was also observed in the control group, the reduction rate of the score was much greater in the treated group by ail 3 assessment methods at weeks 4, 8, and 12. Complete relief of subjective symptoms throughout the 12 weeks’examination was noted in 67% of the subjects in the treated group, but in only 6% in the control group. These results suggest the usefulness of a 5% potassium nitrate dentifrice in Japanese patients with dentinal hypersensitivity.     

Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice

OBJECTIVE: Stannous fluoride is a broad-spectrum anti-microbial agent that has been used in dentistry as a chemical adjunct to prevent dental caries and gingivitis. The objective of this study was to assess the anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice relative to a negative control. METHODS: This was a randomized, 6-month, double-blind, parallel-group gingivitis study conducted according to the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 s using their assigned product. Oral soft-hard-tissue examinations and clinical examinations using the Modified Gingival Index, Gingival Bleeding Index, and the Turesky modification of the Quigley-Hein Plaque Index were performed at baseline, 3 and 6 months post-treatment. RESULTS: A total of 143 subjects were enrolled and 130 of them completed the 6-month study. After 6 months of product usage, the experimental group had 21.7% less gingivitis (p<0.001), 57.1% less bleeding (p<0.001), and 6.9% less plaque (p=0.01) on average compared with the negative control group. No adverse oral soft-hard-tissue effects or extrinsic tooth staining was observed in the study. CONCLUSION: The results demonstrate that use of the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice over a 6-month period provided statistically significant reductions in gingivitis, gingival bleeding, and plaque when compared with a negative control dentifrice.     

An anticalculus dentifrice with sodium hexametaphosphate and stannous fluoride: a six-month study of efficacy

AIM: To compare the anticalculus efficacy of an experimental dentifrice (0.454% stabilized stannous fluoride/sodium hexametaphosphate) with a negative control. METHODS AND MATERIALS: This was a randomized, examiner-blind, parallel group study. After a three-month run-in, qualifying subjects were randomized to the experimental or control dentifrice to use twice a day for six months. Volpe-Manhold Index (V-MI) and oral soft tissue examinations were conducted at baseline, three, and six months. Additional analyses were performed separately at three and six months on three subgroups categorized into high, medium, and low calculus-forming subjects. RESULTS: Compared to the control group, the experimental dentifrice group had a mean calculus score statistically significantly lower at both three months (50%) and six months (55%) post-treatment (p<0.001). Compared to control scores, mean experimental dentifrice calculus scores at three and six months were statistically significantly lower at both points in time for high, medium, and low calculus forming sub-groups (p<0.001). Both products were generally well tolerated. CONCLUSION: The experimental dentifrice revealed significant anticalculus efficacy compared to the control regardless of levels of baseline calculus formation. CLINICAL SIGNIFICANCE: The stannous fluoride/sodium hexametaphosphate dentifrice technology is an effective calculus inhibitor for home care.     

A randomized triple-blind crossover trial of a hydrocolloid-containing dentifrice as a controlled-release system for fluoride

Clinical Oral Investigations - To evaluate retention of intraoral fluoride in biofilm and saliva, an experimental dentifrice containing hydrocolloid (tara gum) was used as a controlled-release...     

Substantivity of amine fluoride/stannous fluoride following different modes of application: A randomized,investigator-blind,placebo-controlled trial

Objective. Amine fluoride/stannous fluoride (ASF) is proven to be effective against plaque and gingivitis. The purpose of this clinical controlled study was to investigate the influence of different application modes on the substantivity of this formulation. Material and Methods. Seventeen healthy volunteers received a professional dental prophylaxis. Undisturbed plaque growth was permitted for the next 48h. In a crossover design, participants received ASF as a single mouthrinse, toothpaste, slurries with high (HA) or low (LA) air content, or a placebo. Vitality of plaque bacteria was investigated before and at 1, 2, 3, 4, 6, and 8h after application of ASF. ANOVA was applied on a 0.05 significance level. Results. Highest reduction of plaque vitality resulted after toothpaste application, followed by mouthrinse, LA, and HA slurry. No changes occurred in the placebo group. Compared to baseline and placebo, statistically significant changes were detected up to 4h in all ASF groups. Toothpaste exerted antibacterial efficacy up to 8h. Vitality reduction was higher in the LA group than in the HA group. Conclusions. The concentration of ASF in formulations influences the time course of the antibacterial effect. Contact of ASF formulations with air might reduce their efficacy.