Clinical evidence on a unique two-step stannous fluoride dentifrice and whitening gel sequence.

PURPOSE: Recently, a unique two-step product was introduced that includes sequential use of a novel 0.454% stannous fluoride dentifrice followed by a 3% hydrogen peroxide whitening gel. The technology targeted advanced gingival health benefits plus esthetic benefits such as tooth whitening. The two-step sequence has unique brushing instructions to maximize the efficacy of each step; the stannous fluoride dentifrice is used for 1 minute of brushing followed by 1 minute of brushing with the hydrogen peroxide gel. This two-step sequence has been studied in numerous clinical trials over a series of years. This comprehensive program included different populations and sites, endpoints and time points, with responses measured versus different positive and negative research controls. A total of six clinical trials are reported herein. Outcomes from this research program demonstrate the significant gingival health efficacy of the two-step product, providing therapeutic efficacy comparable to chlorhexidine, and its positive impact on plaque, tooth stain and breath odor. CLINICAL SIGNIFICANCE: This unique dentifrice/gel sequence delivers a combination of advanced gingivitis efficacy with significant stain reduction - benefits that will positively impact oral health as well as patient compliance.

Initial evidence of two-step dentifrice/gel sequence effects on health: Outcomes from three randomized controlled trials.

PURPOSE: Health-related outcomes from three randomized controlled trials represented the initial research on the feasibility of novel, sequential oral hygiene with a stannous fluoride (SnF2) dentifrice then hydrogen peroxide (H2O2) whitening gel. METHODS: One crossover and two parallel clinical trials were conducted independently. Objectives varied, with individual studies assessing short, intermediate or longer-term outcomes from breath, dental plaque or gingivitis, respectively. Treatments were randomly assigned, and blinded test kits were dispensed containing either: 1) a two-step 0.454% SnF2 dentifrice and then a 3% H2O2 whitening gel sequence and instructions specifying 1+1 minute sequential brushing (experimental); or 2) 0.76% sodium monofluorophosphate dentifrice (Colgate Cavity Protection) and instructions for twice daily use (control). Standard methods were used to measure efficacy (volatile sulfur compounds, plaque area coverage or gingival bleeding) and safety (clinical examination and interview), and to compare treatment responses. RESULTS: Overall, 165 subjects participated in the three trials. Relative to baseline, only the experimental group exhibited significant (P< 0.05) improvements at initial and subsequent timepoints in each trial. Between-group comparisons showed significant (P< 0.05) 30-45% reductions in breath malodor (VSC), plaque (area%) and gingivitis (bleeding sites) favoring the experimental group. Adverse event occurrences were infrequent, mild in severity, and unrelated to dropout. CLINICAL SIGNIFICANCE: Important health-related outcomes from three initial clinical trials established the feasibility of sequential brushing with a two-step 0.454% SnF2 dentifrice and then a 3% H2O2 whitening gel.

Innovations In Dentin Hypersensitivity: A Unique Oxalate-Based Strip Technology.

Dentin hypersensitivity represents one of the most commonly occurring dental problems. Despite its prevalence, the condition is usually underdiagnosed and undertreated. Recently, a user-friendly technology involving an oxalate-based strip was developed for treatment of dentin hypersensitivity. This novel sensitivity strip affords some of the same conveniences seen with whitening strips, and like those strips, may allow direct professional application. Strip usage is similar irrespective of the setting (office or home), with a low total amount of an oxalate gel delivered continuously over a 10-minute period to occlude dentin tubules and reduce sensitivity. Real and transcending evidence (preclinical and clinical), including practice-based research, exists on the strip technology's effects, which makes this supplement particularly relevant to the practicing professional.

Comparative Effects of 1.5% Oxalate Strips Versus 5% Potassium Nitrate Dentifrice on Dentin Hypersensitivity.

A randomized controlled trial was conducted to evaluate the safety and efficacy of a novel 1.5% oxalate sensitivity strip. Healthy adults with dentin hypersensitivity after a cool-air challenge were randomly assigned either three sensitivity strips (Crest® Sensi-Stop™ Strips, Procter and Gamble) plus regular toothpaste (experimental group) or 5% potassium nitrate dentifrice for twice-daily use (control group). First use was supervised, and response was measured immediately after first treatment and again 30 days later after direct provocation with air and tactile stimuli. A total of 79 subjects (mean age 37 years) were randomized and treated. After the first treatment, only the 1.5% oxalate strip group exhibited significant (P less than .0001) immediate sensitivity relief to both air and tactile stimulation. Repeated use improved response and, over 30 days, both treatments were effective. Between-group comparisons favored the episodic strips versus the daily-use dentifrice, with a majority of oxalate strip users having no measured air sensitivity at Day 30. Both treatments were well tolerated. A randomized clinical trial showed immediate and durable sensitivity relief for 1.5% oxalate strips and superior response when compared head-to-head versus a potassium nitrate dentifrice.

Randomized Controlled Trial Evaluating Use of Two Different Oxalate Products in Adults with Recession-Associated Dentin Hypersensitivity.

A randomized positively controlled trial was conducted to evaluate the durable effects of 1.5% oxalate strips on dentin hypersensitivity. Informed consent and baseline measurements were obtained from adults with recession and air-related dentin hypersensitivity. Eligible subjects were randomized to one of two oxalate groups, either 1.5% oxalate gel strips (Crest® Sensi-Stop™ Strips, Procter and Gamble) or a professional oxalate-acid, potassium-salt solution (Super Seal® Dental Desensitizer Liner, Phoenix Dental). Test products were professionally administered at examiner-identified sensitive test sites following each manufacturer's instructions. Subjects received a blinded overwrapped anticavity paste and manual brush, two additional reapplication visits were scheduled over a 1-week period, and subjects returned 1 month later for evaluation. Sensitivity was evaluated using air and water stimuli measured by clinicians (Schiff Index) and subjects (visual analog scale), while safety was assessed by examination. The population (N = 80) was diverse with respect to gender, ethnicity, and age (22 to 82 years). At baseline, the overall mean (SD) air sensitivity was 1.34 (0.47), with individual subject means ranging from 1 to 2.5. Repeated treatment with both the commercial and professional oxalate treatments resulted in significant (P less than .05) reductions in sensitivity for all stimuli and methods. At the 1-month posttreatment recall, there were 84% to 86% reductions in clinically measured cool-air sensitivity for each oxalate group. Groups did not differ significantly (P > .57) on examiner or self-graded air or water sensitivity. In a clinical study, use of 1.5% oxalate gel strips yielded similar benefits as professionally applied oxalate treatments for adults with recession-based dentin hypersensitivity.

In-use peroxide kinetics of 10% hydrogen peroxide whitening strips.

OBJECTIVE: Clinical research was conducted to establish the peroxide degradation profile of a very thin 10% hydrogen peroxide bleaching gel delivered on a flexible polyethylene strip. METHODS: Sixteen subjects participated in this study of Crest Whitestrips Premium, a thin layer of 10% hydrogen peroxide gel. Application was supervised, and strips were removed after five, 10, 30, and 60 minutes. Samples were collected from the strips, teeth, gingiva, and saliva, and peroxide levels were derived using a colorimetric peroxide assay. RESULTS: At five minutes, median peroxide concentrations were 7.3%, 6.4%, and 0.7% for strips, teeth, and gingiva, respectively, declining to 4.6%, 2.9%, and 0.1% at 30 minutes. Salivary samples never exceeded a median concentration of 0.014% at any time point. Samples differed significantly (p < 0.01) with respect to the 30- and 60-minute area-under-the-curve calculations, with the highest concentrations on the strip and teeth, and the lowest on the gingiva and in saliva. Median peroxide concentrations on strips and teeth remained above 2% over 60 minutes. At all post-treatment time points, the gingival peroxide concentration was an order of magnitude lower than the teeth samples. CONCLUSION: Use of 10% hydrogen peroxide whitening strips yielded appreciable peroxide on teeth over a 60-minute period, with rapid peroxide degradation on the gingiva, and exceedingly low accumulation in saliva anytime during use.

Application of digital imaging in tooth whitening randomized controlled trials.

PURPOSE: The development of novel peroxide-based bleaching systems during the last several years has prompted the need for robust clinical methods to evaluate whitening response. Advances in digital camera technology and image analysis software provided the basis for an instrumental method to assess tooth color closely following a technique previously used to quantify plaque on tooth surfaces. In vitro and in vivo research was conducted to determine reproducibility of color measurements using this objective, digital imaging method. METHODS: Each of the 16 tabs in a standard shade guide system was mounted in a jig, and measurement reproducibility was assessed in vitro from paired digital images collected over a 2-day period. Separately, clinical measurement reproducibility was assessed in vivo from paired images of 14 healthy adult volunteers collected over a 2-day period. From these digital images, mean L*, a*, and b* color values were derived for each of the 16 individual shade tabs (in vitro study), or the facial surfaces of the maxillary six anterior teeth (in vivo study) of the 14 subjects. For each data set, variability was determined using ANOVA, and between-visit color measurement reliability was determined from intra-class correlation coefficients (ICCs). RESULTS: In the in vitro study, shade tab yellowness (b*) ranged from 9.0-18.6, lightness (L*) ranged from 63.4-76.2, and redness (a*) ranged from 0.9-3.6. Overall daily means differed by 0.08 units or less, and intra-class correlations for the image pairs were 0.998 for L*, 0.996 for a* and 0.998 for b*. In the in vivo assessment, the 14 volunteers exhibited considerable range in tooth color. Yellowness (b*) ranged from 13.5-21.3, lightness (L*) ranged from 69.2-78.0, and redness (a*) ranged from 5.2-8.8. Clinical measurement of mean tooth color from digital images was highly reproducible across visits. Intra-class correlations for the image pairs were 0.989 for b*, 0.970 for L* and 0.979 for a*.

A 24-hour dental plaque prevention study with a stannous fluoride dentifrice containing hexametaphosphate.

Recently, a novel antibacterial fluoride dentifrice containing stannous fluoride and sodium hexametaphosphate (CrestPRO-HEALTH) was introduced. A digital plaque image analysis (DPIA) technique was used to quantify in situ plaque formation in a population carrying out a phased intervention protocol that included: (1) an initial treatment regimen including toothbrushing with standard sodium fluoride dentifrice in conventional bid brushing, (2) a second treatment regimen where a modified hygiene regimen was applied using standard sodium fluoride dentifrice including a period of 24 hours of non-brushing, and (3) a third treatment regimen where the 24-hour non-brushing regimen was continued using the antimicrobial stannous fluoride/sodium hexametaphosphate dentifrice. The quantitative evaluation of plaque formation was assessed in morning measurements following either standard evening hygiene (treatment period 1) or 24 hours since brushing (treatment periods 2 and 3). Post-brushing plaque measurements were also taken in each treatment regimen. Sixteen subjects completed all three treatment regimens with no side effects or oral complaints. Morning plaque coverage in treatment period 1 was 13.3%. Plaque coverage significantly increased in treatment period 2 when pre-bedtime brushing was discontinued, with 24-hour growth covering 18.4% of the dentition. Intervention of the antimicrobial stannous fluoride/hexametaphosphate dentifrice in treatment period 3 provided significant inhibition of plaque regrowth over 24 hours (15.2% coverage, a 17% reduction vs. sodium fluoride dentifrice control). These results support the strong retention and lasting antimicrobial efficacy of high stabilized stannous fluoride/sodium hexametaphosphate dentifrices.

Use of a physical barrier to improve efficacy of a paint-on whitening gel: a seven-day randomized clinical trial.

OBJECTIVE: This randomized, examiner-blind clinical trial evaluated the impact of a physical barrier on tooth whitening response of a peroxide-containing paint-on gel. METHODOLOGY: A total of 33 adult volunteers, ranging from 18-75 years of age, were randomized to one of two treatment groups: a whitening paint-on gel used alone, or a whitening paint-on gel applied to the tooth surface and immediately covered with a polyethylene strip barrier. Both treatments were used twice a day for seven days, and all subjects used a cavity protection dentifrice and an extra-soft toothbrush twice a day while in the study. Whitening efficacy was assessed using L*a*b* color analysis obtained via digital imaging. Efficacy and safety data were collected at baseline and again at Days 2, 5, and 8. RESULTS: Use of a whitening gel with a protective barrier resulted in significant (p < or = 0.025) color improvement from baseline (as evident by mean deltab* and deltaL*) at Days 5 and 8, while changes from baseline were not significant for the group using whitening gel alone for the same time points. At Day 2, subjects in the barrier group had a significant (p = 0.046) yellowness reduction (deltab*) relative to baseline. Between-treatment comparisons were significant for deltab* at Days 5 and 8 (p < or = 0.015) and for deltab* whitening improvement slopes for the duration of the study (p < 0.002). Both treatments were well tolerated, and no subjects discontinued treatment due to an adverse event. CONCLUSION: Protecting hydrogen peroxide in the whitening gel from the oral environment with a polyethylene barrier increases the magnitude of the whitening response for a paint-on gel, with results evident as early as after five days of product use.

Randomized controlled trial of 10% hydrogen peroxide whitening strips.

OBJECTIVE: This research compared the clinical response of two different peroxide-containing gel formulations delivered using self-applied whitening strips. METHODOLOGY: A randomized, double-blind clinical trial was conducted to compare a one-week 10% hydrogen peroxide thin (0.13 mm) bleaching gel (Crest Whitestrips Premium) to a marketed two-week 6% hydrogen peroxide strip (0.20 mm) control (Crest Whitestrips). The maxillary arch was treated twice daily for 30 minutes. Efficacy (L*a*b* color change) was measured objectively by digital image analysis after one and two weeks. RESULTS: A total of 40 adults ranging from 19-48 years of age participated in the study. Both treatments were effective in whitening teeth, as evidenced by a statistically significant improvement from baseline (p < 0.001) beginning at one week. At that time, the adjusted mean deltab* (SE) (yellowness reduction) for the 10% strip was -2.42 (0.147) compared to -1.91 (0.143) for the 6% strip, with the treatments differing significantly (p = 0.02). At two weeks, the adjusted mean deltab* (SE) for the 10% strip was -3.31 (0.182) compared to -2.49 (0.167) for the control. After two weeks, treatments differed significantly (p < 0.02) for deltab* and deltaL* (lightness improvement). Comparing results from two weeks of the 6% control strip to one week of the 10% strip, the mean deltab* treatment difference was -0.07 (90% confidence interval from -0.44 to +0.31). Both treatments were generally well tolerated, with mild and transient tooth sensitivity or oral irritation representing the most common adverse events. CONCLUSION: Vital bleaching with 10% hydrogen peroxide strips at one week was as effective as 6% hydrogen peroxide strips used for two weeks.

Vital bleaching with a thin peroxide gel: the safety and efficacy of a professional-strength hydrogen peroxide whitening strip.

BACKGROUND: Use of higher peroxide concentrations for professional at-home vital bleaching often balances two factors in patient compliance: whitening and tolerability. Development of a polyethylene strip coated with a very thin (0.10-millimeter) layer of 14 percent hydrogen peroxide gel (Crest Whitestrips Supreme, Procter & Gamble, Cincinnati)--which represents an increase in concentration and a decrease in amount of gel--was believed to allow for greater at-home whitening with little additional oral soft-tissue exposure to peroxide. METHODS: The authors conducted a randomized, double-blind, two-week clinical trial with 38 adults to evaluate the safety and efficacy of twice-daily use of the thin, concentrated bleaching gel strip versus the effects of a control product (Crest Whitestrips, Procter & Gamble). The two products differed only in concentration (14 percent versus 6 percent) and gel layer thickness (0.10 mm versus 0.20 mm). The authors measured efficacy from digital images using the Commission Internationale de l'Eclairage L*a*b* color scale. They assessed safety via subject interviews and clinical examination and compared treatments using analysis of covariance. RESULTS: Relative to baseline color, both strip groups exhibited significant (P < .001) improvement in yellowness, brightness and composite color change. Between-group comparisons after two weeks demonstrated significant (P < .003) color improvement for the experimental strip relative to the control. Both products were well-tolerated generally. Despite the concentration differences, clinical examination of each group showed a similar low level (11 percent) of "minor oral irritation." CONCLUSION: Use of the thin 14 percent hydrogen peroxide gel strip resulted in greater whitening, including 42 to 49 percent greater improvement in tooth color and faster whitening onset than that seen with a 6 percent hydrogen peroxide whitening strip, without clinical evidence of increased oral-tissue irritation. CLINICAL IMPLICATIONS: Use of whitening strips with a thin, concentrated layer of hydrogen peroxide gel may represent a useful approach for professionally directed at-home vital bleaching.

Placebo-controlled clinical trial evaluating a 10% hydrogen peroxide whitening strip.

OBJECTIVE: A placebo-controlled clinical trial was conducted to evaluate the effectiveness and safety of a 10% hydrogen peroxide strip-based whitening system in subjects with tooth discoloration and no previous history of tooth whitening. METHODOLOGY: Informed consent was obtained, and 39 healthy adults were randomly assigned to either 10% hydrogen peroxide whitening strips (Crest Whitestrips Premium) or placebo strips with no peroxide. Strips were used unsupervised twice daily for 30 minutes over a seven-day period. At day four and day eight, tooth color (L*a*b*) was measured on the maxillary anterior teeth from standard digital images, and safety was assessed from examinations and subject reports. RESULTS: After three treatment days, the 10% hydrogen peroxide strip group had significant (p < 0.0001) color improvement from baseline, with means (SD) for deltab* and deltaL* of -1.57 (0.472) and 1.72 (0.619), respectively. Continued strip use from day four to day eight resulted in significant (p < 0.002) incremental improvement in both yellowness and lightness. By the end of treatment (day eight), the adjusted mean (SE) color change between groups was -2.20 (0.275) for deltab* and 2.24 (0.254) for deltaL*, a highly significant (p < 0.0001) color improvement for the 10% hydrogen peroxide group relative to placebo, of similar absolute magnitude for deltab* and deltaL*. Treatment with the 10% hydrogen peroxide strips was well-tolerated, with tooth sensitivity and oral irritation representing the most common findings. CONCLUSION: In this double-blind, placebo-controlled clinical trial, statistically significant tooth whitening was evident after three days' treatment with 10% hydrogen peroxide whitening strips, and color improved with continued usage over seven days.

A new approach to strip-based tooth whitening: 14% hydrogen peroxide delivered via controlled low dose.

Professionally dispensed, take-home whitening products originally consisted of tray systems into which the patient dispensed a peroxide-containing gel. Because the process of inserting peroxide-containing gels into the trays is patient controlled, the resulting exposure of the gingiva to peroxide can be variable, and often high. In addition to concentration, soft tissue irritation is a function of the amount, or dose, of peroxide with which the tissue is challenged. All other things being equal, higher-concentration products will whiten faster because of the peroxide concentration gradient, but they also will lead to poorer soft tissue tolerability because of a higher peroxide challenge. Consequently, take-home trays are somewhat limited with respect to the concentration of hydrogen peroxide that they can safely use. In 2000, strip-based whitening technology was introduced that allowed a controlled, uniform, low dose of peroxide to be applied to the teeth. An execution of this strip-based technology that contained 6.5% hydrogen peroxide, Crest Professional Whitestrips, was launched in 2001. A new professionally dispensed strip product, Crest Whitestrips Supreme, recently has been introduced. A 14% hydrogen-peroxide gel is incorporated onto these strips, but the amount of gel is half of what is on the 6.5% strips. The net result is that the dose, or amount, of peroxide on each strip is essentially the same as for the Professional Whitestrips product. Therefore, the 14% hydrogen-peroxide strip product whitens faster and better than previous strip products, while still being well tolerated by the soft tissue.

In-use comparative kinetics of professional whitening strips: peroxide recovery from strips, teeth, gingiva, and saliva.

A clinical trial was conducted to evaluate the peroxide degradation and dilution kinetics of Crest Whitestrips Supreme, a whitening strip carrying a low, fixed amount of a 14% hydrogen-peroxide bleaching gel. Crest Professional Whitestrips--a 6.5% hydrogen-peroxide strip with a well-established clinical efficacy and safety profile--served as the positive experimental control. A total of 17 healthy adults were enrolled in the crossover study (subjects used both products, and each product was used 4 times by each person). Test strips were applied to the maxillary arch, after which hydrogen-peroxide concentration was measured on the strip, teeth, gingiva, and in saliva over a 60-minute period using standard analytical methods. Treatments were compared at individual time points, and overall using the area-under-the-curve (AUC) calculation of total hydrogen-peroxide exposure (concentration over time). For the higher-concentration strip, hydrogen-peroxide concentration from the strip and teeth samples dropped initially at the 5-minute sampling point, then slowly declined over time. At 30 minutes--the nominal treatment time for these 14% hydrogen-peroxide strips--the median hydrogen-peroxide concentration was 6.2% on the strips and 4.4% on the teeth. In contrast, the gingival and salivary hydrogen-peroxide concentrations were already low and/or below the level of detection by 5 minutes, and remained low throughout the sampling period. Treatments generally differed (P < .001) with respect to hydrogen-peroxide concentrations on the strip and teeth, but not on the gingiva or in the saliva. AUC cumulative measurements through 60 minutes demonstrated 77% higher hydrogen-peroxide levels on teeth for the 14% hydrogen-peroxide strip compared to the 6.5% hydrogen-peroxide strip. This research demonstrates the feasibility of vital bleaching with an exceedingly thin layer of 14% hydrogen-peroxide gel, with little gingival or salivary hydrogen-peroxide exposure.

Initial color change and color retention with a hydrogen peroxide bleaching strip.

PURPOSE: A randomized, double blind clinical trial was conducted to evaluate initial color improvement and post-treatment color retention following vital bleaching with a strip-based tooth whitening system. MATERIALS AND METHODS: After balancing for baseline color, 57 healthy adults were randomized to either whitening strips with a 5.3% hydrogen peroxide bleaching gel (Crest Whitestrips) or placebo strips without hydrogen peroxide. Maxillary and mandibular anterior teeth were treated twice daily for 30 minutes each over a 2-week period, and efficacy was measured objectively by comparing digital images of teeth collected at baseline, end-of-treatment (Week 2) and 6 months after treatment (Month 6). RESULTS: The whitening strip group experienced a highly significant (P< 0.0001) reduction in yellow of -2.0 deltab* units versus baseline and -1.95 deltab* units versus placebo, with similar results noted for the other color parameters in the study. Most of the initial color change remained at 6 months post-treatment, with the whitening strip group continuing to demonstrate highly significant (P< 0.0001) improvements in tooth color relative to baseline and placebo. Age was found to significantly contribute to initial color improvement, with younger subjects experiencing a greater initial reduction in yellowness compared to older participants, but not to post-treatment color retention. The whitening strips were well tolerated, with minor tooth sensitivity and oral irritation representing the most common findings during treatment. There were no persistent or new treatment-related adverse events during the 6-month monitoring period.

Effect of peroxide concentration and brushing on whitening clinical response.

This clinical trial compared the effects of hydrogen peroxide concentration and toothbrushing on clinical response to vital bleaching. Tooth bleaching was accomplished with a flexible, polyethylene strip coated with a hydrogen peroxide bleaching gel worn for 30 minutes twice daily over a 14-day period. A total of 36 subjects were randomized to 1 of 3 treatment groups: 5.3% hydrogen peroxide strip plus prebrushing, 6.5% hydrogen peroxide strip plus prebrushing, or 6.5% hydrogen peroxide strip without prebrushing. Two groups brushed with regular anticavity toothpaste immediately before bleaching, while the other group performed ad libitum brushing only. Tooth color was measured over a 14-day period using digital images of the anterior dentition. Over the 14-day treatment period, all 3 strip groups experienced highly significant (P < 0.001) whitening as evidenced by decreased yellowness (delta b*) and increased brightness (delta L*), as well as composite color change (delta E*) relative to baseline. Keeping brushing constant, the 6.5% hydrogen peroxide strip plus prebrushing group experienced a 31% to 60% improvement in whitening relative to the 5.3% hydrogen peroxide standard. Keeping concentration constant at 6.5% hydrogen peroxide, the prebrushing group experienced a directional 5% to 33% improvement in whitening relative to no prebrushing. All treatments were generally well tolerated. This study demonstrates that for strip-based delivery, increasing hydrogen peroxide concentration to 6.5% results in a significant improvement in efficacy with few tolerability trade-offs.

Overview of a professional tooth-whitening system containing 6.5% hydrogen peroxide whitening strips.

Professionally dispensed, at-home tooth whitening began with 10% carbamide peroxide gels applied to the dentition with custom-made trays. In the 1990s, higher-concentration carbamide peroxide gels were introduced to achieve faster results. Today, 15% and 20% carbamide peroxide gels are commonly used. Recently, a new vital tooth-whitening technique that uses a flexible strip rather than a tray to apply a 5.3% hydrogen peroxide whitening gel was introduced. The new strip-based product was shown to provide whitening equivalent to a 10% carbamide peroxide tray with half the wear time. In addition, the strip eliminated the need to custom fabricate trays for each patient. This article provides an overview of a professionally distributed strip-based whitening system and reviews some of the clinical data which supports the efficacy of the product. This new whitening system includes 42 mandibular and 42 maxillary strips at a higher concentration of 6.5% hydrogen peroxide. In addition, the system also includes a novel dual-action whitening dentifrice to prevent future staining postbleaching and an extrasoft toothbrush. Clinically, the professionally distributed strip-based whitening system provided 96% more efficacy than a popular carbamide plus hydrogen peroxide (equivalent to 10% carbamide peroxide) tray system and 52% more whitening than the 5.3% hydrogen peroxide strip system.

Objective and subjective whitening response of two self-directed bleaching systems.

PURPOSE: To evaluate objective and subjective whitening responses of two marketed vital bleaching systems under intended use conditions. MATERIALSA ND METHODS: The randomized clinical trial evaluated 50 adults who received either a combination system with a 3% hydrogen peroxide bleaching gel, pre-formed dual arch tray, dentifrice and oral rinse (Rapid White), or 6% hydrogen peroxide whitening strips (Crest Whitestrips). Efficacy was assessed objectively from L*a*b* tooth color at Days 7 & 14, while subjective, first-person whitening perception was measured by questionnaire. A cumulative multinomial probability model was generated to predict subjective responses from objectively measured tooth color. RESULTS: At end-of-treatment, adjusted mean deltab* was -2.05 +/- 0.158 for the whitening strip group compared to -0.69 +/- 0.141 for the combination group, with these groups differing significantly (P < 0.0001). This response held across every color parameter and time point in this study. Relative to the combination system, subjects in the whitening strip group rated that product significantly (P < 0.01) more favorably with respect to the amount of whiteness improvement, as well as whitening satisfaction and overall impression. These subjective responses were correlated with objective changes in tooth color measured during treatment. When the deltab* effect was included in a cumulative multinomial probability model, deltaL*, deltaa*, and treatment were non-significant predictors. Odds ratios demonstrate that a subject had 3.3 times (1/0.3003 = 3.33) greater odds of selecting a higher whiteness rating when the value of deltab* was decreased by 1.0 unit (less yellowness). Similar results were noted for whitening satisfaction and overall impression of treatment.

Vital bleaching with two at-home professional systems.

PURPOSE: To compare the whitening effectiveness of two professional vital bleaching systems in a randomized clinical trial. MATERIALS AND METHODS: Balancing for baseline color, 6 9 adult volunteers were randomized to either a whitening strip containing 6.5% hydrogen peroxide (Professional Crest Whitestrips) or a custom tray-based system using both hydrogen and carbamide peroxide (Nite White Excel2). Total contact time was 21 hours for the strip system and 28 hours for the 10% carbamide peroxide equivalent tray system. Whitening response was measured objectively as L*a*b* from digital images of the maxillary anterior teeth. RESULTS: Both treatments resulted in significant (P < 0.01) improvements in yellowness (deltab*), brightness (deltaL*) and overall color (deltaE*). For between group comparisons, strip subjects had a statistically significant or directionally favorable whitening response relative to the tray system at intermediary time points, while at the end-of-treatment, the strip group had highly statistically significant (P < or = 0.005), superior whitening response for all color parameters measured in the study. Both treatments were generally well tolerated, with 35-40% of the subjects in each group reporting minor tooth sensitivity or gingival irritation.