Three randomized studies of dentine hypersensitivity reduction after short-term SnF2 toothpaste use.

AIM: To evaluate effects of a 0.454% stannous fluoride test toothpaste on dentine hypersensitivity (DH) applied by fingertip, then 3 days' brushing, versus a sodium monofluorophosphate-based control. MATERIALS AND METHODS: In three randomized clinical studies, DH was assessed using evaporative (Schiff scale) and tactile (Yeaple probe) stimuli. Participants applied toothpaste to two sensitive teeth by fingertip (60 s each); DH was re-assessed, prior to brushing. Test treatment participants brushed their sensitive teeth, with all participants then brushing all teeth for ≥60 s, twice daily for 3 days. DH was re-assessed. Data were analysed by study and then pooled. RESULTS: In two studies, test treatment significantly reduced DH versus control treatment after fingertip application and 3 days' brushing (both measures). In one study, both treatments significantly reduced DH without between-treatment differences. Mean Schiff differences (95% confidence intervals) for fingertip/3d were as follows: Study 1: -0.09 (-0.280, 0.092)/ -0.18 (-0.442, 0.072); Study 2: -0.72 (-0.839, -0.610)/ -1.02 (-1.150, -0.882); and Study 3: -0.26 (-0.387, -0.123)/ -0.92 (-1.055, -0.793). Pooled analysis indicated test treatment significantly reduced DH versus control (both timepoints, both measures). Toothpastes were generally well-tolerated. CONCLUSION: Studies indicated that single, fingertip application of a SnF2 toothpaste reduced DH versus a control. DH relief increased over 3 days.

Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief.

BACKGROUND: Dentine hypersensitivity (DH) can occur after gum recession or enamel loss and may impact quality of life. Treatments include toothpastes that decrease DH by occluding dentine tubules. One effective occluding ingredient used in toothpastes is stannous fluoride (SnF2), but this can be unstable in aqueous formulation. These three studies aimed to characterise the short-term effects of an experimental, anhydrous SnF2 dentifrice on DH. METHODS: Three examiner-blind, parallel-group studies evaluated DH in participants with the condition after a single brushing and after 3d brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste (Test) or a toothpaste containing 0.76% sodium monofluorophosphate (Control). Test treatment participants brushed two pre-identified sensitive teeth first, then their remaining dentition for ≥1 min ('focused brushing'). Control treatment participants brushed their whole dentition for ≥1 min. DH was measured after single brushing and after 3d twice-daily use, via evaporative (air) (Schiff Sensitivity Scale) and tactile (Yeaple probe) stimuli and analysed using an ANCOVA model. RESULTS: In all studies, after 3d treatment, the Test toothpaste/brushing regimen significantly reduced DH compared to the Control regimen by both evaporative and tactile stimuli assessment (p < 0.0001 for all). The Test regimen also significantly reduced DH from baseline at both time-points by both measures in all studies (p < 0.0001 for all). Mean Schiff sensitivity score differences (95% confidence intervals) between Test and Control regimens after 3d were: Study 1: - 0.45 (- 0.577, - 0.319); Study 2: - 0.40 (- 0.505, - 0.300); Study 3: - 1.31 (- 1.500, - 1.128). Mean tactile score differences were: Study 1: 11.30 (7.927, 14.662); Study 2: 3.57 (2.531, 4.614); Study 3: 24.54 (20.349, 28.736). After single use, in Studies 2 and 3, the Test toothpaste/brushing regimen significantly reduced DH versus Control by both measures (p < 0.001 for all); in Study 1, treatment differences were not significant. Toothpastes were generally well-tolerated. CONCLUSIONS: Taken together, these studies indicated focused brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste reduces DH compared to brushing with a conventional toothpaste after single use, with greater reduction after 3d. TRIAL REGISTRATION: Registrations at ClinicalTrials.gov : Study 1: NCT02832375 (registered 26.July.2016); Study 2: NCT02731833 (registered 26.April.2016); Study 3: NCT02923895 (registered 5.October.2016).

An Exploratory Clinical Study to Monitor Clinical Efficacy of an Occluding Technology Dentifrice in Providing Short Term Relief from Dentinal Hypersensitivity.

OBJECTIVES: To examine dentin hypersensitivity (DH) at multiple time points over a 14-day period in participants who brushed twice daily with a 0.454% SnF2 dentifrice (Test) compared to a 0.76% sodium monofluorophosphate dentifrice with no known anti-sensitivity properties (Control). METHODS: This was a two-week, single-center, randomized, controlled, examiner-blind, two-treatment, parallel-group study in healthy participants with DH. The sensitivity of two selected test teeth and of all sensitive teeth was assessed at baseline and after one, three, seven, 10, and 14 days' treatment in response to evaporative (air) Schiff sensitivity score and visual analogue scale [VAS]) and tactile (tactile threshold) stimuli. DH was also monitored using a shortened version of the Dentin Hypersensitivity Experience Questionnaire (DHEQ) and a single "Tooth Sensitivity Question" (TSQ). RESULTS: Both groups had mean Schiff sensitivity scores that were statistically significantly improved from baseline on all days for the two test teeth and all qualifying teeth (p < 0.0001). There was a statistically significant difference between the dentifrices at Day 1 only, in favor of the Control dentifrice, for the two test teeth (0.28 [95% confidence intervals 0.03,0.53] p = 0.0282) or all qualifying teeth (0.17 [0.02,0.32] p = 0.0273). For tactile threshold, both dentifrices were statistically significantly improved from baseline from Day 3 onwards, with the Test dentifrice showing an improvement at Day 1 (p < 0.05). There were no significant statistical between-treatment differences at any time point. DHEQ questions revealed most participants experienced "sensitivity," "twinging," and "pain," with cold stimuli rated as the highest DH-eliciting. DHEQ Section 1 rating scores improved with the Test dentifrice, but not significantly statistically. DHEQ Section 2 scores statistically significantly improved with both dentifrices (p < 0.0002) with no differences between them. TSQ scores for both groups reduced over the time period. Both dentifrices were generally well-tolerated. CONCLUSIONS: In this study, use of both the Test and Control dentifrices led to DH relief with few statistically significant differences between them. The DHEQ and TSQ showed a reduction of pain during the study period, but there was still a high level of discomfort. Further research on short term relief of DH is required.

Efficacy of an experimental 3% potassium nitrate mouthwash in providing long-term relief from dentin hypersensitivity: An 8-week randomized controlled study (Study 2).

PURPOSE: To evaluate the efficacy of an experimental mouthwash containing 3% potassium nitrate (KNO3) in the relief of dentin hypersensitivity when used as an adjunct to brushing with fluoride toothpaste compared with the use of the same toothpaste alone. METHODS: This was a randomized, two-treatment, examiner-blind, parallel-design single-center, 8-week study in healthy subjects with self-reported and clinically diagnosed dentin hypersensitivity. Subjects were randomized to receive either fluoride toothpaste plus 3.0% KNO2 mouthwash or the same fluoride toothpaste alone, and instructed to use their allocated treatment twice daily for the next 8 weeks. Dentin hypersensitivity was evaluated at baseline and following 4 and 8 weeks of treatment through assessment of responses to evaporative (air) and tactile stimuli [measured by the Schiff sensitivity scale/a visual rating scale (VRS) and tactile threshold, respectively], and using the Dentin Hypersensitivity Experience Questionnaire (DHEQ, a validated quality-of-life instrument for dentin hyper-sensitivity). RESULTS: A total of 135 subjects were randomized and all completed the study. Both treatment groups demonstrated statistically significant improvements in sensitivity from baseline for each clinical measure of sensitivity (P< 0.0001) at Week 4 and Week 8. The toothpaste plus mouthwash group showed greater reductions in sensitivity at both timepoints for all clinical measures; between-treatment differences were only statistically significant for responses to an evaporative (air) stimulus (Schiff sensitivity score and VRS) at Week 4. There was evidence of an improvement in dentin hypersensitivity-associated quality of life as measured by changes from baseline in several DHEQ parameters for both treatment groups, but there were no statistically significant differences between treatments. CLINICAL SIGNIFICANCE: Although in the current study adjunctive use of a 3% KNO2 mouthwash did not provide statistically significant improvements in dentin hypersensitivity for all clinical measures at all timepoints compared with use of fluoride toothpaste alone, the reductions in sensitivity observed in this study are compatible with the findings of a previous study that showed adjunctive use of a 3% KNO2 mouthwash to be effective in providing relief from dentin hypersensitivity after 8 weeks' twice-daily use.

Efficacy of an experimental 3% potassium nitrate mouthwash in providing long-term relief from dentin hypersensitivity:An 8-week randomized controlled study (Study 1).

PURPOSE: To evaluate the efficacy of an experimental mouthwash containing 3% potassium nitrate (KNO3) in relieving dentin hypersensitivity when used as an adjunct to brushing with fluoride toothpaste compared with use of the same toothpaste alone. METHODS: This was one of three randomized, two-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed dentin hypersensitivity. Subjects were randomized to receive either fluoride toothpaste plus 3% KNO3 mouthwash or the same fluoride toothpaste alone, and instructed to use their allocated treatment twice daily for the next 8 weeks. Dentin hypersensitivity was evaluated at baseline and following 4 and 8 weeks of treatment through assessment of responses to evaporative (air) and tactile stimuli [measured by the Schiff Sensitivity Scale, a visual rating scale (VRS), and tactile threshold, respectively], and using the Dentin Hypersensitivity Experience Questionnaire (DHEQ; a validated quality-of-life instrument for dentin hypersensitivity). RESULTS: A total of 216 subjects were randomized and 214 completed the study. Both treatment groups demonstrated statistically significant reductions from baseline for each clinical measure of sensitivity (P≤ 0.01) at Weeks 4 and 8. Use of the 3% KNO3 mouthwash after brushing with fluoride toothpaste resulted in statistically significantly greater reductions in sensitivity to an evaporative (air) stimulus (mean Schiff score and mean VRS, P< 0.001; primary objective mean Schiff score at Week 8, P< 0.0001) and statistically significantly higher tactile threshold (P< 0.001) at Weeks 4 and 8 compared with toothpaste alone. The DHEQ responses reflected the clinical outcomes for several parameters, indicating a significant improvement in oral health-related quality of life after 8 weeks' use of the 3% KNO3 mouthwash. CLINICAL SIGNIFICANCE: The results of this study suggest that daily use of a 3% KNO3 mouthwash as an adjunct to brushing with fluoride toothpaste provides clinically relevant improvements in dentin hypersensitivity after 8 weeks' twice-daily use.

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.

Efficacy of an experimental toothpaste containing 5% calcium sodium phosphosilicate in the relief of dentin hypersensitivity: An 8-week randomized study (Study 1).

PURPOSE: To evaluate the efficacy of an experimental toothpaste containing 5% (w/w) calcium sodium phosphosilicate (CSPS) in relieving dentin hypersensitivity (DH) compared with control toothpastes containing no known anti-sensitivity ingredients. METHODS: This was the first of two exploratory, randomized, four-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed DH. The experimental toothpaste contained 5% CSPS with a modified surfactant system, developed to enhance its organoleptic properties. Efficacy was evaluated against an abrasivity-matched placebo formulation (0% CSPS) with additional abrasive silica replacing the CSPS, and two commercially available fluoride toothpastes as controls. After an initial lead-in period, subjects were randomized to one of the four study treatments and instructed to brush twice daily for the next 8 weeks. DH was assessed at baseline and following 4 and 8 weeks of treatment by response to tactile and evaporative (air) stimuli, and using a Dentine Hypersensitivity Experience Questionnaire (DHEQ; a validated quality-of-life measure for DH). RESULTS: A total of 134 subjects were randomized and completed the study. All treatments demonstrated statistically significant reductions in sensitivity from baseline at Week 4 and Week 8 for each clinical measure of sensitivity (all P ≤ 0.001). The 0% CSPS toothpaste demonstrated small but statistically significant reductions in Schiff sensitivity score compared with the other study toothpastes at Week 8 (all P< 0.05), whereas the experimental 5% CSPS toothpaste significantly improved the tactile threshold at Week 4 compared with the 0% CSPS toothpaste (P = 0.0467). The DHEQ responses did not reveal any consistent statistically significant within-treatment changes from baseline or between-treatment differences. Correlation analysis showed weak-to-moderate associations between the DHEQ outcomes and clinical endpoints. Study treatments were well tolerated. The treatment differences observed in this exploratory study were small and inconsistent between measures. The reasons for the inconsistencies are not clear but may be related to the properties of the abrasivity-matched 0% CSPS formulation, with the increased level of dental silica conferring an advantage in terms of reducing DH. The ability of dental silicas to occlude exposed dentin tubules and thereby reduce DH has been demonstrated in previous studies, and may warrant further clinical investigation.

Efficacy of an experimental toothpaste containing 5% calcium sodium phosphosilicate in the relief of dentin hypersensitivity: An 8-week randomized study (Study 2).

PURPOSE: To compare the efficacy of an experimental toothpaste containing 5% (w/w) calcium sodium phosphosilicate (CSPS) in relieving dentin hypersensitivity (DH) with that of control toothpastes containing no known anti-sensitivity ingredients. METHODS: This was the second of two exploratory, randomized, four-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed DH. After an initial lead-in period, subjects were randomized to one of four study treatments: the experimental toothpaste containing 5% CSPS with a modified surfactant system, developed to enhance its organoleptic properties; an abrasivity-matched placebo formulation (0% CSPS) with additional abrasive silica replacing the CSPS; or one of two commercially available fluoride toothpastes as controls. Subjects were instructed to brush twice daily for the next 8 weeks. DH was assessed at baseline and following 4 and 8 weeks of treatment by response to tactile and evaporative (air) stimuli, and using a Dentine Hypersensitivity Experience Questionnaire (DHEQ; a validated quality of life measure for DH). RESULTS: A total of 137 subjects were included in the efficacy analysis. The experimental 5% CSPS toothpaste demonstrated statistically significant reductions from baseline in sensitivity at Week 4 and Week 8 for each clinical measure (all P< 0.01). It also demonstrated significantly greater improvements in DH compared with the two control toothpastes for the majority of clinical measures at Week 4 (P ≤ 0.01) and for all clinical measures at Week 8 (all P < 0.01). The abrasivity-matched 0% CSPS toothpaste was associated with similar outcomes to the 5% CSPS toothpaste. The DHEQ responses did not reveal any consistent statistically significant within-treatment changes from baseline or between-treatment differences. Strong correlations with DHEQ outcomes were only observed for the subjects' sensitivity rating in response to evaporative (air) stimuli at Week 8. Study treatments were well tolerated.

Utilising daily diaries to examine oral health experiences associated with dentine hypersensitivity.

BACKGROUND: The current investigation examined the determinants of oral health experiences associated with dentine hypersensitivity using prospective diary methodology. METHODS: Staff and students from a large UK university who had self-diagnosed dentine hypersensitivity completed an online daily diary and text survey for 2 weeks recording their mood, oral health-related coping behaviours, coping and pain appraisals, pain experiences and functional limitations. Cross sectional and lagged path analyses were employed to examine relationships. RESULTS: One hundred one participants took part in the diary study. Participants had a mean age of 26.3 years (range = 18-63) and most were female (N = 69). Individuals who used more oral health-related coping behaviours predicted and experienced greater levels of pain on subsequent days. Negative mood also predicted worse pain outcomes. The daily diary method provided a useful avenue for investigating variations in oral health experiences and relationships between variables that can fluctuate daily. CONCLUSIONS: Psychological variables such as coping and mood play an important role in the pain experiences of people with dentine hypersensitivity. The study highlights the benefits of using prospective methods to elucidate the experiences of people with oral conditions.

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.

The role of illness beliefs and coping in the adjustment to dentine hypersensitivity.

AIM: Dentine hypersensitivity is a common oral health problem, however, there has been little research on how people cope with this condition. This study aimed to quantify the effects of illness beliefs and coping strategies on the health outcomes of individuals with dentine hypersensitivity. MATERIALS AND METHODS: Participants were purposively sampled from students and staff in one large UK University and 101 self-diagnosed dentine hypersensitivity sufferers participated in the longitudinal study. Participants were required to complete questionnaires which assessed health anxiety, specific illness beliefs (control, consequences, illness coherence, timeline perspectives and emotional representations), coping strategies (passive and active coping) and oral health-related and health-related quality of life (OHRQoL and HRQoL) at baseline and 1 month follow-up. RESULTS: Over half of the participants (N = 56) experienced sensations in their teeth on a daily basis and the majority had experienced dentine hypersensitivity for at least 1 year (N = 87). Structural equation modelling indicated that predictors of OHRQoL and HRQoL impacts at follow-up were frequency of sensations, low levels of illness coherence, negative emotional representations, greater health anxiety and use of passive coping strategies at baseline. CONCLUSIONS: Illness beliefs and coping strategies predict oral and health-related quality of life outcomes in people with dentine hypersensitivity.

Derivation of a short form of the Dentine Hypersensitivity Experience Questionnaire.

AIM: To derive and evaluate a short form of the Dentine Hypersensitivity Experience Questionnaire. METHODS: Data from three previous studies of dentine hypersensitivity (n = 353) were pooled and randomly divided into half. Ten- and 15-item short forms were derived in the first half of the data using the item impact and regression methods. The four short forms were evaluated in the second half. RESULTS: The 10 and 15-item versions of the regression short form detected impacts in 37% and 61% of participants, respectively, compared to 68% and 93% using the item impact method. All short forms had internal consistency (Cronbach's α) >0.84 and test-retest reliability (ICC) >0.89. All correlated with the long form (all r > 0.93, p < 0.001) and with the effect of the mouth on everyday life (all r ≥ 0.73, p < 0.001). None of the short forms detected a treatment effect in two trials although all four showed a tendency to detect an effect in a trial where the long form had done so. CONCLUSIONS: The 15-item short form derived with the item impact method performed better than other short forms and appears to be sufficiently robust for use in individual patients.

The Dentine Hypersensitivity Experience Questionnaire: a longitudinal validation study.

AIM: To validate the Dentine Hypersensitivity Experience Questionnaire in terms of responsiveness to change and to determine the minimally important difference. MATERIALS AND METHODS: The study was a secondary analysis of data from three randomized controlled trials with 311 participants. Three aspects of responsiveness were examined: change within individuals, differences among people who improved, stayed the same or worsened using an external referent and change due to treatment. Responsiveness to treatments of differing efficacy was assessed in trials with negative and active controls. RESULTS: The measure showed excellent internal reliability, test-retest reliability and criterion validity. The measure was highly responsive to change within individuals (Cohen's effect sizes: 0.28, 0.56, 0.86) showing decreases in the total score (i.e. improvement in OHrQoL) across all trials. The effect sizes in participants whose self-reported QoL "improved" were large (0.73-1.31). Dentine Hypersensitivity Experience Questionnaire detected a treatment effect in one of two negative control trials (effect size: 0.47). Dentine Hypersensitivity Experience Questionnaire scores were similar in the test and control groups in the active control trial. The minimally important difference range was between 22 and 39 points. CONCLUSIONS: The measure is longitudinally reliable, valid and responsive and can discriminate between treatments of different efficacy.

Construction and validation of the quality of life measure for dentine hypersensitivity (DHEQ).

AIM: To develop and validate a condition specific measure of oral health-related quality of life for dentine hypersensitivity (Dentine Hypersensitivity Experience Questionnaire, DHEQ). MATERIALS AND METHODS: Questionnaire construction used a multi-staged impact approach and an explicit theoretical model. Qualitative and quantitative development and validation included in-depth interviews, focus groups and cross-sectional questionnaire studies in a general population (n=160) and a clinical sample (n=108). RESULTS: An optimized DHEQ questionnaire containing 48 items has been developed to describe the pain, a scale to capture subjective impacts of dentine hypersensitivity, a global oral health rating and a scale to record effects on life overall. The impact scale had high values for internal reliability (nearly all item-total correlations >0.4 and Cronbach's α=0.86). Intra-class correlation coefficient for test-retest reliability was 0.92. The impact scale was strongly correlated to global oral health ratings and effects on life overall. These results were similar when DHEQ was validated in a clinical sample. CONCLUSIONS: DHEQ shows good psychometric properties in both a general population and clinical sample. Its use can further our understanding of the subjective impacts of dentine sensitivity.

A comparative clinical study investigating the efficacy of a dentifrice containing 8% strontium acetate and 1040 ppm fluoride in a silica base and a control dentifrice containing 1450 ppm fluoride in a silica base to provide immediate relief of dentin hypersensitivity.

OBJECTIVE: The objective of this clinical study was to evaluate and compare the efficacy of a dentifrice containing 8% strontium acetate and 1040 ppm fluoride (from sodium fluoride) in a silica base (test dentifrice) to a control dentifrice containing 1450 ppm fluoride (from sodium fluoride) in a silica base, to reduce dentin hypersensitivity immediately after a single dab-on self-application, and after subsequent twice-daily brushing for three days. METHODS: This was a randomized, examiner-blind, two-arm parallel group, three-day clinical study with seventy-nine subjects, stratified based on baseline tooth sensitivity. Tooth sensitivity was determined through subject responses to both evaporative (Schiff and Visual Analogue Scale [VAS]) and tactile stimuli (Yeaple probe), prior to and immediately after subjects self-applied a single pea-sized amount of either the test or control dentifrice to qualifying sensitive teeth, massaging the toothpaste onto the sensitive area for one minute. Tooth sensitivity was further assessed in response to the same stimuli after subjects brushed twice daily for an additional three days. Subject assessments were performed by the same examiner throughout the study. RESULTS: Seventy-nine subjects completed this clinical study. Both subject groups exhibited reductions in dentin hypersensitivity directly after a single dab-on application. These reductions were significant across all measures for the test dentifrice. Between-treatment analyses showed the test dentifrice to be significantly better at relieving subjects' sensitivity across all measures (Schiff p = 0.0003, tactile p = 0.0003, and VAS p = 0.0077) compared to the control. After the additional three days of twice-daily brushing, between-treatment analyses showed the test dentifrice to be significantly better at relieving subjects' sensitivity across all measures (Schiff p = 0.0102, tactile p = 0.0493, and VAS p = 0.0067) than the control dentifrice. CONCLUSION: The 8% strontium acetate, 1040 ppm fluoride dentifrice provided significant within-treatment reductions in dentin hypersensitivity for all measures at both time points (immediate and three-day brushing). Compared to the control dentifrice, significant between-treatment reductions in sensitivity were observed after a single dab-on application for all measures, and following the additional twice-daily brushing for three days in favor of the 8% strontium acetate, 1040 ppm fluoride dentifrice.

A comparative clinical study evaluating stain removal efficacy of a new sensitivity whitening dentifrice compared to commercially available whitening dentifrices.

OBJECTIVE: To assess the extrinsic stain removal efficacy of a new sensitivity dentifrice containing sodium tripolyphosphate (STP) to marketed whitening toothpastes after six weeks of product use. METHODS: This was a single-center, double-blind, stratified, six-week clinical study comparing the reduction in stain area and intensity of Sensodyne Extra Whitening to Crest Maximum Strength Sensitivity Protection Whitening plus Scope and Colgate Tartar Control Plus Whitening Mint dentifrice, as measured by MacPherson's Modification of the Lobene Stain Index (MMLSI) in a forced stain model. RESULTS: Two-hundred and ninety-five subjects completed the study. Tooth stain MMSLI scores showed significant differences between Sensodyne and Crest dentifrices in favor of Sensodyne for all surface sites (p = 0.014), and individually for facial (p = 0.023), lingual (p = 0.027), and interproximal (p = 0.014) surfaces. No significant statistical differences between Sensodyne and Colgate dentifrices were observed for any of the surfaces. CONCLUSION: Results from this stain removal clinical study demonstrate significant extrinsic stain removal efficacy for all dentifrices relative to baseline. Significant differences between the two marketed sensitivity whitening dentifrices were demonstrated in favor of the new Sensodyne Sensitivity 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.

Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity: An 8-week randomized controlled study.

BACKGROUND: Mouthrinses containing potassium salts have been shown to be effective for the relief of dentinal hypersensitivity (DH) when used adjunctively to toothbrushing with a nonsensitivity toothpaste. METHODS: The authors conducted a randomized, 8-week, single-center, examiner-blinded, parallel-group clinical trial with 191 participants with DH. Participants were randomized to twice-daily use of either 3% potassium nitrate (KNO3) mouthrinse plus fluoride toothpaste or the same fluoride toothpaste alone. The primary outcome was change from baseline in response to an evaporative (air) stimulus at 8 weeks, measured using the Schiff sensitivity scale. Secondary outcomes were response to an evaporative (air) stimulus with the Schiff sensitivity scale (4 weeks) and a visual rating scale (4 and 8 weeks) and response to a tactile stimulus (4 and 8 weeks). RESULTS: Both groups showed statistically significant improvements in evaporative (air) sensitivity from baseline after 4 and 8 weeks (P < .0001). At weeks 4 and 8, the authors observed significant improvements from baseline in tactile sensitivity only in the KNO3 mouthrinse group (P < .0001). Between-treatment comparisons for all sensitivity measures at both time points showed statistically significantly greater DH reductions in the KNO3 mouthrinse group compared with the toothpaste-alone group (P = .0004 for the visual rating scale at week 4; P < .0001 for all other measures and time points). Treatments were generally well tolerated. CONCLUSIONS: Twice-daily use of a 3% KNO3 mouthrinse, adjunctive to toothbrushing with fluoride toothpaste, provided significant improvements in DH compared with fluoride toothpaste alone. PRACTICAL IMPLICATIONS: Addition of 3% KNO3 mouthrinse to a typical oral hygiene regimen of toothbrushing with fluoride toothpaste provides an alternative strategy for the management of DH. ClinicalTrials.gov: NCT02226562.

A randomised exploratory clinical evaluation of dentifrices used as controls in dentinal hypersensitivity studies.

OBJECTIVES: To explore relative efficacy of six negative-control dentifrices utilised as controls in clinical studies compared with two dentine hypersensitivity (DH)-relief dentifrices used 2×/day for 8 weeks. METHODS: Six control dentifrices differing in terms of fluoride source (sodium fluoride/sodium monofluorophosphate), abrasive base (silica/dicalcium phosphate), relative dentine abrasivity (RDA) (∼17 to ∼180) and colour (white/blue/multicoloured stripes) were compared with a depolarising dentifrice (5% KNO3; RDA ∼70-97; 'Test 1') and an occlusion-technology dentifrice (0.454% SnF2; RDA ∼160-180; 'Test 2'). DH was assessed using tactile and evaporative (air) (measured by Schiff Sensitivity Scale and a visual rating scale [VRS]) stimuli. RESULTS: In total 249 subjects were randomized. All dentifrices yielded statistically significant improvements from baseline on all endpoints. The two DH-relief dentifrices ranked highest in terms of improvement in scores over the control dentifrices. While there was a clear differentiation between Test 1 and control dentifrices on both measures at 4/8 weeks, for Test 2, statistically significant improvements in Schiff scores were observed over all controls at Week 4 but only over three at Week 8. At Week 4 none of the controls separated from Test 2 on tactile threshold; all separated by Week 8. VRS scores did not separate test and control dentifrices. Dentifrices were generally well-tolerated. CONCLUSIONS: The six negative-control dentifrices can be used to assess dentifrices considered to be effective in reducing DH. Although response ranges for commercially available negative controls varied, these results may begin to set acceptable performance ranges for control dentifrices in DH trials.

Implications of pathologist concordance for breast cancer assessments in mammography screening from age 40 years.

Three pathologists reviewed slides and reports of cancers arising in both the study and control populations of the U.K. trial of annual mammography screening from age 40 years. A total of 875 cases were scored independently as noninvasive, microinvasive, or invasive cancer, with the last also evaluated for histology grade, type, and lymphatic vascular invasion. Of these, 870 (99.2%) were confirmed malignant, 1 case had cytology only, and 5 were judged by all reviewers as benign. Reviewer complete concordance for the three classes of malignancy was achieved in 826 (95%) and majority agreement in 31 (3.6%) of 870 with complete data. All three readers recorded grade in 736 cancers, giving a kappa statistic of 0.69, 0.52, and 0.66 for grades I, II, and III, respectively, and 0.61 overall. Agreement that the cancer was special type or not was obtained in 671 (89.0%) with complete concordance in the nature of the type in 504 and majority view in 167; another 58 (7.7%) were characterised as "part special" pattern, with type disagreement in 23 (3%). The kappa statistic for single type subcategories in those cancers was substantial, at 0.68 overall. This improved to 0.76 for the last 230 invasive cancers after the pathologists agreed more explicit criteria for type discrimination. There was almost perfect agreement between original and review diagnosis of breast malignancy for both noninvasive/microinvasive and invasive cancer (kappa 0.84 and 0.91, respectively), justifying confidence in the diagnosis of breast cancer by U.K. pathologists. The specialists agreed substantially on qualitative histology features of type and grade of cancers, and improved further for typing by defining criteria. These consensus data, along with invasive size and node status, are reliable for use as surrogate measures of outcome, and to enhance interpretation of effect, when the trial case population sources are disclosed.