1. Anti-Hypersensitivity

Anti-Hypersensitivity

In addition to the onset of smear layer formation, the durability of the tubule occlusions also impacts the effectiveness of the anti-hypersensitivity agent. Stabilized stannous fluoride dentifrice forms a smear layer that is resistant to both daily mechanical and acid challenges. Figure 15 compares a stabilized stannous fluoride dentifrice to two other anti-hypersensitivity toothpastes which also act by a tubule occlusion mechanism. The smear layer of the stabilized stannous fluoride dentifrice is more resistant to a dietary acid challenge than that of either of the other products (Zsiska et al. 2011).

Fluid movement in open dentinal tubules

Figure 12. Fluid movement in open dentinal tubules

Mechanism of action of stabilized stannous fluoride dentifrice

Early treatments using solutions and later gels demonstrated the desensitizing effect of stannous fluoride. The dentinal tubules are occluded by precipitated stannous salts, inhibiting fluid movement within the tubules and thereby preventing nerve stimulation and pain (Figures 13, 14; Miller et al. 1994; Thrash et al. 1995).

The effective occlusion of dentinal tubules with stabilized stannous fluoride dentifrice
Pre-and posttreatment with open and occluded dentinal tubules

Figure 13. Dentinal tubule occlusion: Note the effective occlusion of dentinal tubules with stabilized stannous fluoride dentifrice (SEM x2000)

Figure 14. Pre-and post-brushing SEMs: pre-and post-treatment with open and occluded dentinal tubules Courtesy of Cosmetics & Toiletries

Relative dentinal tubule occlusion for stabilized stannous fluoride dentifrice versus two other anti-hypersensitivity dentifrices after treatment, mechanical agitation, and one minute acid exposure

Figure 15. Relative dentinal tubule occlusion for stabilized stannous fluoride dentifrice versus two other anti-hypersensitivity dentifrices after treatment, mechanical agitation, and one minute acid exposure.

In addition to the onset of smear layer formation, the durability of the tubule occlusions also impacts the effectiveness of the anti-hypersensitivity agent. Stabilized stannous fluoride dentifrice forms a smear layer that is resistant to both daily mechanical and acid challenges. Figure 15 compares a stabilized stannous fluoride dentifrice to two other anti-hypersensitivity toothpastes which also act by a tubule occlusion mechanism. The smear layer of the stabilized stannous fluoride dentifrice is more resistant to a dietary acid challenge than that of either of the other products (Zsiska et al. 2011).

Stannous fluoride protects against dentinal hypersensitivity

HYPERSENSITIVITY RESEARCH SUMMARIES

The following study summaries represent a sample of research demonstrating the benefits of stabilized stannous fluoride dentifrice for the reduction of hypersensitivity.

Efficacy and Safety of a Novel Stabilized Stannous Fluoride and Dentifrice for Dentinal Hypersensitivity

Reference: Schiff T, He T, Sagel L, et al. J Contemp Dent Pract. 2006;7(2):1-8.

CONCLUSION

Crest® PRO-HEALTH provided statistically significant reductions in dentinal hypersensitivity at 4 and 8 weeks compared to the sodium fluoride control dentifrice.

OBJECTIVE

To compare the efficacy of Crest® PRO-HEALTH vs a negative control dentifrice in the reduction of dentinal hypersensitivity over an 8-week period.

MATERIALS AND METHODS

  • Crest® PRO-HEALTH™ (a novel 0.454% stabilized stannous fluoride dentifrice with sodium hexametaphosphate for cosmetic benefits) was compared to a negative control dentifrice containing 0.243% sodium fluoride (Crest® Cavity Protection).
  • Study subjects were 90 generally healthy adults with moderate dentinal hypersensitivity: minimum of 2 bicuspid or cuspid teeth with sensitivity criteria of Yeaple Probe Index score = 10 g and Schiff Air Sensitivity Scale score of >1.
  • Experimental 0.454% stabilized SnF2 dentifrice (Crest® PRO-HEALTH Clean Mint [Smooth Formula], Procter & Gamble)
  • Tooth sensitivity was measured by tactile examination using the Yeaple probe (only teeth responding positively to 10 g and rechallenge at 10 g were evaluated) and cold air using the Schiff Air Index (teeth responding to air stimulus were evaluated).
  • Oral soft tissue examinations were performed.
  • Subjects were randomized to either the stabilized stannous fluoride dentifrice or the control dentifrice.
  • Subjects brushed twice daily with their assigned dentifrice using a manual soft toothbrush for 8 weeks.
  • Subjects were assessed again for sensitivity and safety at weeks 4 and 8.

RESULTS

  • Data were analyzed for all 90 subjects (45 in each treatment group).
  • Schiff Air Index scores were statistically significantly lower for the stabilized stannous fluoride group than the sodium fluoride control group at both weeks 4 and 8 (P<0.0001).
  • Compared to the sodium fluoride control group, the stannous fluoride group showed a 33% lower Schiff Air Index score (adjusted mean) than the sodium fluoride control group at week 4 and a 44% lower score at week 8.
  • Yeaple Probe Index scores were statistically significantly higher for the stabilized stannous fluoride group than the sodium fluoride control group at both weeks 4 and 8 (P<0.0001).
  • Compared to the sodium fluoride control group, the stabilized stannous fluoride group had a mean Yeaple Probe Index score 14 units higher (representing a mean desensitizing improvement of 114% greater) than that of the sodium fluoride control group at week 4, and 11 units higher (representing a mean desensitizing improvement of 71% greater) at week 8.
  • No adverse events were reported or observed.
Lower Schiff Air Index scores indicate less tooth sensitivity

Lower Schiff Air Index scores indicate less tooth sensitivity

DESENSITIZING EFFECT OF A STABILIZED STANNOUS FLUORIDE DENTIFRICE

Full text available in the Research Database at www.dentalcare.com

Reference: Schiff T, Saletta L, Baker RA, et al. Compend Contin Educ Dent. 2005;26(9 suppl 1):35-40.

CONCLUSION

Crest® PRO-HEALTH showed a clinically and statistically significant decrease in hypersensitivity compared to a negative control dentifrice.

OBJECTIVE

To evaluate the desensitizing properties of Crest® PRO-HEALTH compared to a negative control dentifrice.

MATERIALS AND METHODS

  • Crest® PRO-HEALTH (0.454% stabilized stannous fluoride dentifrice with sodium hexametaphosphate for cosmetic benefits) was compared to a marketed negative control dentifrice containing 0.243% sodium fluoride (Crest® Cavity Protection).
  • Study subjects were adults with a minimum of 2 bicuspid/cuspid teeth with sensitivity criteria of Yeaple Probe Index = 10 g and Schiff Air Sensitivity Scale score of >1.
  • Experimental 0.454% stabilized SnF2 dentifrice (Crest® PRO-HEALTH Clean Mint [Smooth Formula], Procter & Gamble)
  • Tooth sensitivity was measured by tactile examination using the Yeaple probe and thermal examination using the Schiff Air Index.
  • Oral soft tissue examinations were conducted and adverse events recorded.
  • Subjects were randomized to either the stabilized stannous fluoride dentifrice or the control dentifrice.
  • Subjects brushed twice daily with their assigned dentifrice using a manual soft toothbrush for 8 weeks.
  • Subjects were examined again for tooth sensitivity and safety at weeks 4 and 8.

RESULTS

  • Data were analyzed for 77 subjects who had complete data.
  • Yeaple Probe Index scores were statistically significantly higher for the stabilized stannous fluoride group than the sodium fluoride control group at both weeks 4 and 8 (P<0.0001). Higher Yeaple Probe Index scores indicate less tooth sensitivity.
  • Compared to the sodium fluoride control group, the stabilized stannous fluoride group had a mean Yeaple Probe Index score 1.6 times that of the sodium fluoride group at week 4 and 2 times at week 8.
  • Schiff Air Index scores were statistically significantly lower for the stabilized stannous fluoride group than the sodium fluoride control group at both weeks 4 and 8 (P<0.0001). Lower Schiff Air Index scores indicate less tooth sensitivity.
  • Compared to the sodium fluoride control group, the stabilized stannous fluoride group showed a 36% lower Schiff Air Index score (adjusted mean) than the sodium fluoride group at week 4 and a 44% lower score at week 8.
  • No adverse events were reported or observed.
Adjusted Mean Schiff Air Index Score

Lower Schiff Air Index scores indicate less tooth sensitivity

A Clinical Trial Evaluating Immediate Sensitivity Relief of a 0.454% Stannous Fluoride Dentifrice

Reference: He, ML Barker, Qaqish J, et al. J Clin Dent 2011; 22: 46-50.

KEY CLINICAL RESULTS

  • The stannous fluoride (SnF2) dentifrice provided superior sensitivity protection relative to the negative control immediately after the first use based on the Thermal Schiff Index (13.8%, P<0.0001) and the Thermal Air Visual Analog Scale (14.6%, P<0.0001). See Figures 1 & 2.
  • The SnF2 dentifrice also provided superior (P<0.0001) relief relative to the negative control at Day 3 and at Week 2 based on the Thermal Schiff Air Index (31.8% and 61.3%, respectively), the Thermal Air Visual Analog Scale (34.8% and 66.6%, respectively) and the Tactile Yeaple Probe (186% and 239%, respectively). See Figures 1 & 2 and Table 1.
  • The test products were well tolerated.

Figure 1. Thermal Schiff Air Index Adjusted Mean Scores
(Lower score indicates less sensitivity)

Thermal Schiff Air Index Adjusted Mean Scores

Figure 2. Thermal Air Visual Analog Scale Adjusted Mean Scores
(Lower score indicates less sensitivity)

Thermal Air Visual Analog Scale Adjusted Mean Scores

Table 1. Tactile Yeaple Probe Mean Scores
(Higher score indicates less sensitivity)

Tactile Yeaple Probe Mean Scores

OBJECTIVE

To evaluate the efficacy of a SnF2 dentifrice in the reduction of dentinal hypersensitivity after immediate use, 3 days and 2 weeks of use as compared to a negative control dentifrice.

STUDY DESIGN

  • This was a controlled, randomized, examiner-blind, two-treatment, parallel group clinical trial.
  • One hundred eleven healthy adult subjects with moderate dentinal hypersensitivity were enrolled and randomized to one of two treatment groups.
  • Crest® PRO-HEALTH Advanced — 0.454% Stannous fluoride (1100 ppm fluoride), The Procter & Gamble Company, Cincinnati, OH.
  • At the Baseline visit, subjects received an oral soft tissue (OST) exam to evaluate the overall health of the mouth and then were reassessed for tooth sensitivity. Subjects with at least two sensitive teeth demonstrating reproducible sensitivity to both thermal and tactile stimuli and who met all eligibility criteria were enrolled in the study. For those subjects who had greater than two teeth meeting the eligibility criteria, only two were selected for enrollment in the study.
  • Subjects were then randomized to treatment (either Crest® PRO-HEALTH Sensitive Shield with 0.454% stannous fluoride, The Procter & Gamble Company or Colgate Cavity Protection dentifrice with 0.76% Sodium monofluorophosphate, Colgate-Palmolive). Products and treatment kits were identical in appearance to preserve blinding.
  • Subjects were instructed, according to manufacturer’s usage instructions, to brush with their assigned dentifrice thoroughly twice a day (morning and evening). Subjects in the stannous fluoride dentifrice group brushed the sensitive teeth first.
  • Subjects performed their first product use on site under the supervision of site staff. Immediately (within 5 minutes) following the first treatment, both the examiner and subjects re-assessed thermal sensitivity for each enrolled tooth using the Schiff Air Index (assessed by examiner) and Thermal Air Visual Analog Scale (assessed by subjects).
  • Safety and efficacy measurements, using Schiff Air Index, Thermal Air Visual Analog Scale and Tactile Yeaple Probe, were re-assessed at the Day 3 and Week 2 study visits.

A Randomized Clinical Trial Evaluating a 2-step Stannous Fluoride Dentifrice and Whitening Gel System Versus a Potassium Nitrate Dentifrice for Sensitivity Relief

Reference: Gerlach RW, Underwood J, Miner M. Data on file, 2016.

KEY CLINICAL RESULTS

  • A 2-step stannous fluoride dentifrice and whitening gel system (Crest® PROHEALTH [HD], CPH-HD) provided superior tactile and thermal sensitivity relief (P<0.05) versus a positive control potassium nitrate dentifrice (Sensodyne® Extra Whitening). Both groups provided a significant benefit relative to baseline for both measures (P<0.0001). See Figures 1 & 2.
  • Seventy-two percent (72%) of teeth tested in the CPH-HD group experienced an improvement in thermal sensitivity compared to 53% in the positive control group. Fifty-five percent of teeth tested using the CPH-HD product experienced relief from tactile sensitivity compared to 37% for the positive control.

Figure 1. Mean thermal sensitivity scores at Baseline and Week 2. N=69

Mean thermal sensitivity scores at Baseline and Week 2. N=69

Figure 2. Mean tactile sensitivity scores at Baseline and Week 2. N=69

Mean tactile sensitivity scores at Baseline and Week 2. N=69

OBJECTIVE

To evaluate changes in dentinal hypersensitivity in response to using a two-step stannous fluoride dentifrice and whitening gel system relative to a positive control potassium nitrate sensitivity toothpaste.

  • This was a randomized, controlled, double-blinded study to assess changes in dentinal hypersensitivity over a 2 week period.
  • 71 healthy adult volunteers with current dentinal hypersensitivity were enrolled and randomized to one of the groups for twice a day oral hygiene:
  •  

    - Crest® PRO-HEALTH [HD]: Step 1 is a 0.454% stannous fluoride dentifrice; Step 2 is a 3% is a hydrogen peroxide whitening gel (Procter & Gamble)

    - Positive Control: Sensodyne Extra Whitening with sodium fluoride and 5% potassium nitrate (GlaxoSmithKline)

    - Both groups used a soft, manual toothbrush (Oral-B® Indicator®, Procter & Gamble)

     

  • Assessment of dentinal hypersensitivity was made at baseline (before any treatment) and after 2 weeks of using the randomly assigned treatment using the Schiff Air Index1 (thermal) and Yeaple Probe2 (tactile).
  • Safety was assessed from clinical examination.

CLINICAL COMMENT

Dentinal hypersensitivity is defined as a brief, sharp pain from the exposure of dentin to thermal, tactile, osmotic, chemical, or evaporative stimuli, which cannot be attributed to any other form of dental defect or disease. Patients commonly manage dentinal hypersensitivity by using a dentifrice containing a desensitizing agent, such as potassium nitrate or stannous fluoride. Potassium nitrate is reported to reduce sensitivity by interfering with the transmission of pain signals. Stannous fluoride has been shown to occlude open dentin tubules, reducing fluid flow in response to stimuli and thereby reducing pain.

Stabilized stannous fluoride dentifrice has been shown to provide superior relief from thermal and tactile dentinal hypersensitivity versus negative and positive controls.3 Consistent with published literature, the 2-step stannous fluoride dentifrice and whitening gel system provided superior sensitivity relief compared to a marketed potassium nitrate whitening dentifrice.* This 2-step system has also been shown to provide gingivitis reductions comparable to chlorhexidine* with significant whitening benefits.4,5 Thus, dental professionals can recommend this system to patients with dentinal hypersensitivity with confidence they will not only experience relief from sensitivity, but also improvements in gingival health and tooth whitening.

* via Step 1 stannous fluoride dentifrice
1 Schiff T, et al. J Clin Dent 1994;5 Spec No: 87-92.
2 Schiff T, et al. J Contemp Dent Pract 2006;May;(7)2:001-008.
3 Walters P. Dentinal Hypersensitivity: A Review. Updated Dec 2014; dentalcare.com CE Course #200.
4 Gerlach RW, et al. J Dent Res 2015;94 (Spec Iss A): Abstract 293.
5 Garcia-Godoy, C et al. J Dent Res 2016; 96 (Spec Iss A): Abstract 92.

Clinical Significance: Hypersensitivity

Stannous Fluoride Clinical Significance
  • Given the high incidence of dentin hypersensitivity, the effectiveness of stabilized stannous fluoride dentifrice provides clinicians with an efficacious desensitizing dentifrice to recommend to patients.
  • Stabilized stannous fluoride dentifrice offers anti-hypersensitivity benefits and provides multiple other important benefits concurrently with treating hypersensitivity.
  • Stabilized stannous fluoride dentifrice provides both rapid and sustained sensitivity relief with continued use.
  • In addition to rapid onset, the stabilized stannous fluoride dentifrice smear layer is resistant to acid challenges which occur through the modern diet.
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