A randomized clinical study to evaluate the effect of an ultra-low abrasivity dentifrice on extrinsic dental stain.

PURPOSE: To investigate the stain-removal efficacy of an experimental ultra-low abrasivity anti-sensitivity dentifrice containing sodium tripolyphosphate (STP) and a cocamidopropyl betaine/sodium methyl cocoyl taurate detergent system. METHODS: This was a single-center, examiner-blind, randomized, parallel-group study. Extrinsic dental stain was assessed on the facial surfaces of the six maxillary and six mandibular anterior teeth and the lingual surfaces of the six mandibular anterior teeth using the Macpherson modification of the Lobene Stain Index (MLSI). Treatments were: ultra-low abrasivity dentifrice [5% w/w KNO3, 5% w/w STP, 1,100 ppm fluoride as sodium fluoride; relative dentin abrasivity (RDA) ~10; n=54]; moderate abrasivity fluoride dentifrice (1,100 ppm fluoride as sodium monofluorophosphate; RDA ~68; n= 57); higher abrasivity daily-use whitening dentifrice (1,100 ppm fluoride as sodium fluoride; RDA~137; n= 57). Subjects brushed for 1 minute, twice daily, for 8 weeks. RESULTS: Mean total MLSI [ Area × Intensity (A×I) ] change from baseline score at Weeks 4 and 8 was significant (P< 0.0001) for all groups. At Week 8, for the ultra-low abrasivity dentifrice versus the moderate and higher abrasivity dentifrices, mean total MLSI (A×I) scores (P< 0.0001), along with MLSI endpoints in facial, lingual, and interproximal regions (P= 0.0035 to P< 0.0001), favored the ultra-low abrasivity dentifrice. Dentifrices were generally well-tolerated. The ultra-low abrasivity dentifrice containing 5% STP reduced extrinsic dental stain more effectively than moderate or higher abrasivity dentifrices. CLINICAL SIGNIFICANCE: The ultra-low abrasivity, anti-sensitivity dentifrice containing 5% STP reduced extrinsic dental stain more effectively than moderate or higher abrasivity dentifrices, and is thus suitable for patients with sensitive teeth who wish to control extrinsic dental stain.

Randomized Controlled Trial to Explore the Effect of Experimental Low Abrasivity Dentifrices on Enamel Gloss and Smoothness, and the Build-up of Extrinsic Tooth Stain.

OBJECTIVES: To evaluate and compare examiner-assessed changes in enamel gloss, extrinsic dental stain, and surface smoothness following one, two, four, and eight weeks of twice-daily use of an experimental low abrasivity desensitizing dentifrice (relative dentin abrasivity [RDA] ~40) containing 5% sodium tripolyphosphate (STP) chemical cleaning agent and 1% aluminum trioxide abrasive. This was compared with an ultra-low abrasivity dentifrice (5% STP only; RDA ~13), a moderate abrasivity fluoride dentifrice (RDA ~80), and a higher abrasivity marketed whitening dentifrice (RDA ~142). METHODS: This was a single-center, examiner-blind, randomized, controlled, parallel group study in healthy adults stratified by gloss score and age. Following a washout period with a conventional silica abrasive dentifrice, subjects received a dental scale and polish and were randomized to treatment. Subjects brushed their teeth for two minutes, twice daily, with their assigned dentifrice. Enamel gloss was assessed visually by comparing the facial surfaces of the maxillary incisors to the Sturzenberger gloss standards. Extrinsic dental stain was measured on the 12 anterior teeth (facial and lingual) using the Macpherson modification of the Lobene Stain Index (MLSI). Tooth smoothness was assessed using scanning electron microscope (SEM) analysis of a silicone impression of the central incisors. RESULTS: Of 120 screened subjects, 95 were randomized to the study. Subjects using the low abrasivity aluminum trioxide/STP dentifrice demonstrated statistically significant (p < 0.05) and increasing improvements in surface gloss over baseline at all time points, with a significant treatment effect compared to all other study dentifrices from Week 2 (p < 0.05). With respect to dental stain, the low abrasivity dentifrice group had the lowest stain score at each post-treatment time point and demonstrated statistically significantly less stain compared to all study dentifrices at Weeks 2 (p < 0.05) and 8 (p < 0.01). For tooth smoothness, at Week 8, statistically significant increases in surface smoothness were observed for most treatment groups compared to baseline (p < 0.05), except for the moderate abrasivity dentifrice. CONCLUSIONS: This study shows the benefit of a low abrasivity dentifrice containing STP and aluminum trioxide in reducing stain build-up and increasing tooth gloss compared to a non-alumina ultra-low abrasivity STP-containing dentifrice, and moderate and high abrasivity dentifrices, over an eight-week period.

A Randomized Clinical Study to Evaluate the Efficacy of an Experimental 3.75% (w/w) Potassium Chloride Dentifrice for the Relief of Dentin Hypersensitivity.

OBJECTIVES: To evaluate the clinical efficacy of an experimental "Test" dentifrice containing 3.75% (w/w) potassium chloride (KCl) in reducing dentin hypersensitivity (DH) compared with that of a standard fluoride "Reference" dentifrice after eight weeks' twice-daily brushing. METHODS: This was a randomized, controlled, examiner-blind, stratified, parallel-group, single-center study in healthy subjects with selfreported and clinically diagnosed DH. After an initial lead-in period, subjects were randomized to either the Test (n = 67) or the Reference dentifrice (n = 66) and instructed to brush twice daily for the next eight weeks. DH was assessed at baseline and following two, four, and eight weeks of dentifrice use by response to an evaporative air stimulus (as evaluated by Schiff sensitivity score and 100 mm visual analog scale [VAS]) and by response to a tactile stimulus (tactile threshold). RESULTS: Both dentifrices were associated with statistically significant reductions in DH from baseline after two, four, and eight weeks' use, as determined by all efficacy measures (all p < 0.0001). The reduction in Schiff sensitivity score was significantly greater in the Test dentifrice group compared with the Reference dentifrice group at all time points (p < 0.0001). There was a statistically significantly greater increase in tactile threshold in the Reference dentifrice group compared with the Test dentifrice group after eight weeks (p < 0.05); however, reductions in DH as determined by VAS were not significantly different between the treatment groups at any time point. Both dentifrices were generally well tolerated. CONCLUSIONS: Throughout eight weeks of use, the experimental 3.75% (w/w) KCl dentifrice was more effective than the Reference fluoride dentifrice in reducing DH, as determined by the primary endpoint of Schiff sensitivity score. Secondary assessment measures of change in DH (VAS score and tactile threshold) were not consistent with this finding.

A Randomized Non-Inferiority Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentin Hypersensitivity.

OBJECTIVES: Calcium sodium phosphosilicate (CSPS) is a particulate bioactive material incorporated into oral healthcare products for the treatment of dentin hypersensitivity (DH). This study aimed to determine whether a dentifrice containing 5% CSPS and fluoride as sodium fluoride (NaF; "Test dentifrice") was non-inferior to a dentifrice containing 5% CSPS and fluoride as sodium monofluorophosphate (SMFP; "Comparator dentifrice") in reducing DH after eight weeks' twice-daily brushing. METHODS: This was a randomized, examiner-blind, parallel-group, non-inferiority study in healthy adults with self-reported and clinically diagnosed DH. After an initial lead-in period, subjects were randomized to either the Test (n = 150) or Comparator dentifrice (n = 154) and instructed to brush twice daily for the next eight weeks. DH was assessed at baseline and following four and eight weeks of dentifrice use by response to a tactile stimulus (tactile threshold) and evaporative (air) stimulus (Schiff sensitivity score and 100 mm visual analog scale [VAS]). The non-inferiority margin was defined as 6 mm on the VAS. RESULTS: Both dentifrices were associated with statistically significant reductions in DH from baseline after four and eight weeks' use for all efficacy parameters (all p < 0.0001). There were no statistically significant differences between the groups. After eight weeks' use, the between-treatment difference in VAS scores was 2.67 mm (per-protocol analysis) in favor of the Comparator dentifrice; the upper limit of the 95% confidence interval (CI) of the between-treatment difference in VAS scores exceeded the pre-specified non-inferiority margin of 6 mm (upper 95% CI = 7.4). The non-inferiority margin was also exceeded after four weeks. Both dentifrices were generally well tolerated. CONCLUSIONS: The pre-defined non-inferiority margin of 6 mm was not met, thus it is not possible to conclude from the present analysis that the Test dentifrice is non-inferior to the Comparator. However, for all efficacy measures, a statistically significant reduction in DH was observed for both dentifrice groups. There were no statistically significant differences between dentifrice groups, suggesting that changing the source of fluoride from SMFP to NaF does not affect the overall efficacy of the dentifrice in alleviating DH.

A Randomized Clinical Study Investigating the Stain-Removal Potential of Two Experimental Dentifrices.

OBJECTIVE: To evaluate the ability of two experimental desensitizing dentifrices, both containing a chemical cleaning agent, one with ultra-low abrasivity and one with low abrasivity, a standard fluoride dentifrice, and a daily-use whitening dentifrice to remove extrinsic tooth stain. METHODS: This was a single-center, examiner-blind, randomized, controlled, four-treatment, parallel-group study in healthy adults. Extrinsic stain was evaluated using the Macpherson modification of the Lobene Stain Index (MLSI). At baseline, eligible subjects with a total MLSI (area x intensity [A x I]) score of 15 for the facial surfaces of the 12 anterior teeth were stratified (based on total MLSI [A x I] score [< 45 = low; ≥ 45 = high] and smoking status) and randomized to treatment with one of four dentifrices: an experimental ultra-low abrasivity desensitizing dentifrice (relative dentin abrasion [RDA] -12); an experimental low abrasivity desensitizing dentifrice (RDA -40); a standard fluoride dentifrice with moderate abrasivity (RDA -80); and a whitening dentifrice with higher abrasivity (RDA -142). Both desensitizing dentifrices contained 5% potassium nitrate and 5% sodium tripolyphosphate (a chemical cleaning agent). Treatment effects were evaluated after four and eight weeks of twice-daily brushing. RESULTS: In total, 142 subjects were randomized and 133 subjects completed the study. All study dentifrices demonstrated statistically significant reductions in extrinsic tooth stain from baseline after four and eight weeks of twice-daily use (p < 0.01). There were no statistically significant between-treatment differences for the primary variable (mean MLSI [A x I] score across all assessed sites) at four or eight weeks, and no notable trends were observed. CONCLUSION: All study dentifrices reduced extrinsic tooth stain. The experimental ultra-low and low abrasivity desensitizing dentifrices containing 5% sodium tripolyphosphate performed similarly to both a moderate abrasivity standard fluoride dentifrice and a higher abrasivity whitening dentifrice.

An Exploratory Randomised Study to Evaluate the Efficacy of an Experimental Occlusion-based Dentifrice in the Relief of Dentin Hypersensitivity.

PURPOSE: To compare the efficacy of a 2.5% w/w smaller particle-size (ca 4 µm) calcium sodium phosphosilicate (CSPS) dentifrice (test) to an occluding dentifrice (8% w/w arginine) (comparator) and a negative control dentifrice in an 8-week, randomised, controlled, parallel-group, stratified (maximum baseline Schiff sensitivity score) study in adults with dentin hypersensitivity. MATERIALS AND METHODS: The sensitivity of two selected teeth was assessed at baseline and after 1, 2, 4 and 8 weeks in response to evaporative (air) (Schiff sensitivity score and visual analogue scale [VAS]) and tactile (tactile threshold) stimuli. RESULTS: Of 151 randomised subjects, 147 completed the study. Statistically significant changes from baseline were reported for test and comparator dentifrices at all weeks on all measures (p < 0.05) with no statistically significant differences between them. The negative control dentifrice group was statistically significantly different from baseline in all measures by week 8 (p < 0.05). Test and comparator dentifrices demonstrated statistically significantly greater improvements in Schiff sensitivity from week 2 compared to the negative control (p < 0.05). There was a statistically significant difference in favour only of the comparator dentifrice over the negative control at week 8 when examining tactile threshold (p = 0.0435) and at week 4 with VAS (p = 0.0425), with no other between-group differences. The dentifrices were generally well tolerated. CONCLUSION: No statistically significant differences were found between a small particle size 2.5% w/w CSPS dentifrice and an 8% w/w arginine dentifrice in terms of a dentine hypersensitivity decrease.

Stain control with two modified stannous fluoride/sodium tripolyphosphate toothpastes: A randomised controlled proof of concept study.

OBJECTIVE: To compare build-up of extrinsic tooth stain following use of two novel anhydrous stannous fluoride/sodium tripolyphosphate (SnF2/STP) toothpastes with adjusted (lower) relative dentin abrasivities (RDAs) versus a marketed control and a reference toothpaste. METHODS: Following prophylaxis, 220 adults with extrinsic dental stain on anterior teeth facial surfaces were randomised to 4 weeks' twice-daily brushing with either novel 0.454% w/w SnF2 (1100ppm fluoride)/5% w/w STP toothpastes with differing levels of abrasive silica: 'Test RDA∼58'; 'Test RDA∼77', or a reference: 'Ref RDA∼80' (1000ppm fluoride from sodium monofluorophosphate) or marketed control toothpaste: 'Ref RDA∼120' [0.454% w/w SnF2 (1100ppm fluoride)/5% w/w STP]. Primary endpoint was total Macpherson modification of the Lobene Stain Index (MLSI) area×intensity (A×I) score at Week 4 for Test toothpastes versus Ref RDA∼80. Secondary endpoints were total MLSI (A×I) for all toothpastes versus Ref RDA∼120. RESULTS: After 4 weeks, mean total MLSI scores for Test RDA∼58, Test RDA∼77 and Ref RDA∼80 were all lower than Ref RDA∼120. Ranking order of performance for controlling stain build-up was: Test RDA∼77 > Test RDA∼58 > Ref RDA∼80 > Ref RDA∼120. There was no statistical difference between Test RDA∼58 and Ref RDA∼80; Test RDA∼77 was statistically lower than RDA∼80. All toothpastes were generally well-tolerated. CONCLUSION: This study showed low levels of stain build-up after 4 weeks' twice-daily use of novel, low abrasivity, anhydrous SnF2 toothpaste formulations (RDA∼58, RDA∼77), similar to marketed toothpastes (RDA∼80; RDA∼120). Lowering the RDA of appropriately formulated SnF2 toothpastes therefore may not negatively impact stain build-up potential (Clinicaltrials.gov NCT03160703). CLINICAL SIGNIFICANCE STATEMENT: This study indicates lowering RDA of an anhydrous SnF2 toothpaste does not appear to negatively impact its overall dental stain control potential. Development of appropriately formulated SnF2 toothpastes with lower abrasivity may have additional benefits for individuals with dentin hypersensitivity by managing potential dentin wear.

A method development randomised clinical study investigating efficacy of an experimental oral rinse in providing long-term relief from dentinal hypersensitivity.

OBJECTIVES: To evaluate and compare clinical efficacy of a 1.5% dipotassium oxalate monohydrate (KOX)-containing oral rinse ('Test') for the relief of dentinal hypersensitivity (DH) against Negative Control and Placebo oral rinses, adjunctive to twice-daily brushing with a standard fluoride dentifrice, after 8 weeks. METHODS: This was a randomised, examiner blind, parallel-group, method development study in participants with DH, assessed at baseline and after 4 and 8 weeks by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale [VRS]) and a tactile stimulus (Yeaple probe). To boost compliance, study features included recruiting only regular oral rinse users, use of an oral rinse during acclimatisation, weekly supervised rinsing and twice-daily text reminders. RESULTS: After 8 weeks, adjusted mean change from baseline in Schiff sensitivity score was significantly lower in the Test rinse group (n=43) versus the Negative Control group (n=23) (difference: -1.22; 95% CI -1.657, -0.782); tactile threshold score was significantly higher in the Test rinse group compared to the Negative Control rinse (difference: 37.46g; 95% CI: 22.916, 51.995). Similar significant differences in Schiff/tactile scores were also demonstrated after 4 weeks use, after 4 and 8 weeks use as assessed by VRS and as compared to the Placebo rinse (n=23) in all instances. Study products were generally well tolerated. CONCLUSIONS: The Test rinse showed statistically significant improvements in DH compared to the Negative Control and Placebo rinses after 8 weeks twice daily use. Compliance with the rinsing regimen and study visits was excellent. CLINICAL SIGNIFICANCE: Additional compliance features incorporated into this dentinal hypersensitivity study - recruitment of regular oral rinse users only, acclimatisation rinse, weekly supervised rinsing at the study site, twice-daily text reminders - appear to have been of benefit to the overall study design as compliance was high, and primary and secondary objectives were met.

Stain control with two experimental dentin hypersensitivity toothpastes containing spherical silica: a randomised, early-phase development study.

AIMS: To determine in human participants whether toothpastes containing small quantities of a novel spherical silica, added to provide enhanced cleaning properties, could achieve similar or greater extrinsic dental stain removal compared to toothpastes containing standard dental abrasive silica concentrations. MATERIALS AND METHODS: One hundred and twenty-three adults with extrinsic dental stain were randomised to one of four parallel groups for 8 weeks' twice-daily brushing with an experimental toothpaste containing either 0.5% or 1% spherical silica (with relative dentin abrasivity [RDA] of ~38 and ~58, respectively), or marketed toothpastes containing either 6% (RDA ~ 36) or 16% (RDA ~ 166) standard abrasive silica. The objective was to evaluate the ranking order in extrinsic dental stain removal at Week 8, as measured by MacPherson modification of Lobene stain index Area × Intensity. RESULTS: Small treatment differences were observed between toothpaste formulations. The ranking order in extrinsic dental stain removal was: experimental 1% spherical silica toothpaste >16% standard abrasive silica toothpaste >6% standard abrasive silica toothpaste >experimental 0.5% spherical silica toothpaste. Toothpastes were generally well tolerated. CONCLUSION: This early-phase development study suggests that toothpaste formulations with low concentrations of a novel spherical silica abrasive with high-cleaning capability are generally well tolerated and appropriate for further development.