Clinical evaluation of a new 10% carbamide peroxide tooth-whitening agent. Clinical response of three whitening products having different peroxide delivery: comparison of tray, paint-on gel, and dentifrice. Comparative tooth whitening efficacy of 18% carbamide peroxide liquid whitening gel using three different regimens. Clinical comparison of two self-directed bleaching systems. Comparative clinical investigation of the tooth whitening efficacy of two tooth whitening gels. Efficacy of a novel, nontray, paint-on 18% carbamide peroxide whitening gel. Comparison of clinical efficacy and safety of three professional at-home tooth whitening systems. A randomized clinical trial comparing a novel 5.3% hydrogen peroxide whitening strip to 10%, 15%, and 20% carbamide peroxide tray-based bleaching systems. A six-month study of two self-applied tooth whitening products containing carbamide peroxide. Vital bleaching with two at-home professional systems. Tooth-whitening efficacy and safety: a randomized and controlled clinical trial. Randomized clinical trial comparing overnight use of two self-directed peroxide tooth whiteners. Comparative efficacy and tolerability of two direct-to-consumer tooth whitening systems. Clinical evaluation of bleaching agents of different concentrations. Initial color change and color retention with a hydrogen peroxide bleaching strip. A clinical evaluation of 10 percent vs. 15 percent carbamide peroxide tooth-whitening agents. Vital bleaching with a thin peroxide gel: the safety and efficacy of a professional-strength hydrogen peroxide whitening strip. Comparative clinical evaluation of two professional tooth-whitening products. A 3-year clinical trial into the effect of fluoride content and toothpaste abrasivity on the caries inhibitory properties of a dentifrice. A clinical investigation of the efficacy of three different treatment regimens for the control of plaque and gingivitis. Oral hygiene regimens, plaque control, and gingival health: a two-month clinical trial with antimicrobial agents. Effects of combined application of antimicrobial and fluoride varnishes in orthodontic patients. [The caries-protective efficacy of 2 fluoride varnishes in a 2-year controlled clinical trial].
NUPRO Gold Tooth Whitening System was evaluated for efficacy according to the proposed ADA guidelines for acceptance. Sixty participants with discolored anterior teeth participated in a 14-day, double-blind, clinical trial. The participants were matched for age, gender, and oral health status and were given either a placebo gel without the active agent or the NUPRO Gold active gel, which they wore in a custom-fabricated mouth guard for home use. The shade of each participant's maxillary anterior teeth was evaluated using a value-oriented Vita Lumin Vacuum Shade Guide before the study. The same shade guide was used to determine shade changes. Time of use of the agent and potential side effects, such as tooth and gingival hypersensitivity and tissue irritation, were assessed at all recall examinations and were recorded by participants in daily diaries. The average shade change for the placebo users was less than one shade. The average shade change for the NUPRO Gold users was 6.96 shades. Tooth hypersensitivity varied from none to severe. Tissue irritation was minimal. The results of these evaluations indicate that NUPRO Gold is effective as a tooth-whitening system, when administered properly under the supervision of a dentist, with commonly reported side effects of transient tooth sensitivity and minimal gingival sensitivity. Little or no change in tissue health was noted. This study was supported by Dentsply Preventive Care (York, Pennsylvania). Comparative clinical research was conducted to evaluate the efficacy and safety of three peroxide-containing tooth whitening products having different peroxide delivery.
                A total of 43 healthy adults who met entrance criteria were randomly assigned to either a dual-phase, anticavity, 1% hydrogen peroxide dentifrice with a manganese gluconate activator, an 18% carbamide peroxide paint-on gel, or a 5% carbamide peroxide professional custom tray system. Following manufacturer's instructions, the activated dentifrice was used at least twice daily for two minutes, while the paint-on gel was applied twice daily. The custom tray, a barrier system and the experimental control for this study, was worn continuously for six to eight hours daily. Tooth color (L*a*b*) was measured on the maxillary anterior teeth from standard digital images, while safety was assessed from examination and subject report.
                At Day 15, the custom tray group had a significant (p < 0.002) reduction in yellowness and increased lightness, with adjusted mean (SE) deltab* of -1.83 (0.210) and deltaL* of 1.45 (0.292). The custom tray group experienced on average greater color improvement compared to either the paint-on gel or activated peroxide whitening dentifrice, differing significantly (p < 0.01) from either of the barrier-free systems with respect to deltab*, deltaL*, deltaE*, and deltaW*. In comparison, 14-days' use of the paint-on gel and activated dentifrice did not result in significant (p > 0.10) color improvements from baseline for deltab*, deltaL*, or deltaW*, with these two barrier-free systems not differing significantly (p > 0.26) with respect to any individual or composite color parameters. Tooth sensitivity and oral irritation were the most common safety findings in the tray and dentifrice groups (there were no adverse events in the paint-on group), and no subject discontinued treatment early because of a treatment-related adverse event.
                In head-to-head 14-day testing, a low concentration (5% carbamide peroxide) barrier-based tray system yielded superior tooth color improvement compared to two barrier-free delivery systems-an 18% carbamide peroxide paint-on gel and a 1% hydrogen peroxide dentifrice with a metal activator. Recently, a novel paint-on liquid whitening gel--Colgate Simply White Clear Whitening Gel--which contains 18% carbamide peroxide, has been developed as a self-administered tooth bleaching system. The purpose of the present study was to determine the efficacy and safety of this product using alternate exaggerated or simplified treatment regimens.
                This was a three-week clinical trial using a parallel, double-blind, stratified protocol with three different instructions for application: 1) twice-daily, no air-drying, and 15 minutes without eating/drinking; 2) three times daily, 30-second air-drying and 30 minutes without eating/drinking; or 3) four times daily, 30-second air-drying and 30 minutes without eating/drinking. One-hundred and twenty (120) healthy volunteers were balanced into three equal groups based on shade scores (A3 or darker). Clinical evaluations (shade guide, oral tissue health, gingival index and visual analog sensitivity score) were performed on each group at baseline and weekly for the next 21 days. At the conclusion of the study, a survey of the subjects' opinions on their assigned product regimen was also conducted.
                Subjects who used Colgate Simply White Clear Whitening Gel three and four times daily achieved the greatest shade improvement (5.88 +/- 1.53 shades, and 5.57 +/- 1.54, respectively). However, these values were only about one shade better than the value observed for the more convenient, twice-daily, "no-dry" regimen (4.51 +/- 1.77 shades), though they were statistically significant (p < 0.05). The result for the four-times daily protocol was not statistically different from the three-times group. Also, no differences were observed between the groups concerning oral tissue health, gingival index or tooth sensitivity, and no adverse effects were observed or reported regardless of the regimen used. Surveys completed by the subjects showed that those who used the twice-daily, "no-dry" regimen found the product to be the easiest to use, the most comfortable and the most pleasant tasting.
                It can be concluded from the clinical data that three or four applications of Colgate Simply White Clear Whitening Gel per day provided better efficacy. In addition, the use of the whitening gel twice daily, even without "dry time" and only 15 minutes without eating/drinking, yielded results that were comparable to previously reported results using the original on-label directions. The potential additional benefit to the "simplified regimen" is that it was perceived to be the most convenient and comfortable. The use of Colgate Simply White Clear Whitening Gel up to four times daily for up to three weeks is also safe, and the tendency of abusing the product with more frequent daily use may be deterred by the inconvenience reported by the study subjects. This randomized clinical trial compared the clinical efficacy and tolerability of 2 marketed self-directed vital tooth-whitening systems.
                Balancing for baseline tooth color, self-reported coffee/tea use, and age, 57 adult volunteers were randomized to either a whitening strip containing 6% hydrogen peroxide or a tray-based 10% carbamide peroxide/dentifrice/mouth rinse combination system. Following the manufacturer's directions, the strip group bleached twice daily for 30 minutes, whereas the tray group bleached twice daily for 20-30 minutes, preceded by tooth brushing with a whitening dentifrice and followed by mouth rinsing with a whitening solution. Treatment extended for 14 days, with evaluation at day 7 and again at day 14. Whitening response was measured objectively as L*a*b* from standardized digital images of maxillary anterior teeth. Tolerability was assessed by oral examination and subject interview. Efficacy comparisons were made using analysis of covariance, whereas tolerability was compared using the nonparametric Wilcoxon rank-sum test.
                Both treatments resulted in statistically significant (P < 0.01) improvements from baseline for all color parameters. For between-group comparisons, the 6% hydrogen peroxide strips yielded a nearly 3-fold reduction in yellowness (deltab*), a nearly 2-fold improvement in lightness (deltaL*), 2.6 times greater redness reduction (deltaa*), and a more than 2-fold change in overall color (deltaE*) compared to the tray-based combination system. Between-group comparisons were statistically significant for the all color parameters at both the day 7 and day 14 evaluations (P < 0.001). In general, 7-day use of the whitening strips provided significantly greater color improvement relative to the combination dentifrice/gel/rinse system at day 14. In addition, the groups differed significantly (P < 0.05) in bleaching tolerability severity-days, with the strip system demonstrating better overall tolerability compared to the combination system.
                The single-step 6% hydrogen peroxide strips demonstrated better overall clinical response, in terms of both tooth-whitening efficacy and tolerability, than the multiple-step tray-based combination system. The objective of this randomized, double-blind, parallel-group clinical study was to compare the tooth whitening efficacy of two tooth whitening gel products--Colgate Simply White Night Clear Whitening Gel containing either 25% carbamide peroxide, or 8.7% hydrogen peroxide--when used once daily at night.
                Following a baseline tooth shade evaluation using the Vita Shade Guide, qualifying adult male and female subjects from the Central New Jersey area were randomized into two treatment groups, which were balanced for baseline Vita Shade Guide scores, gender and age. The treatment groups were: 1) a tooth whitening gel containing 25% carbamide peroxide; or 2) a tooth whitening gel containing 8.7% hydrogen peroxide. All subjects were given a commercially available, non-whitening dentifrice and a soft-bristled toothbrush at the beginning of the study. In addition, they were also given one of the two tooth whitening gel products. All subjects were instructed to brush their teeth for one minute twice daily (morning and evening) with the non-whitening toothpaste. The subjects were further instructed to apply their assigned tooth whitening gel product once daily at night, per the instructions provided. Evaluations of tooth shade for each subject were repeated after two weeks, and again after three weeks of product use.
                Fifty-nine (59) subjects complied with the protocol and completed the three-week study. At both the two-week and three-week examinations, all subjects exhibited statistically significant (p < 0.05) tooth shade lightening relative to baseline tooth shade. Further, there was no statistically significant difference in tooth shade lightening between the two tooth whitening gel products.
                The results of this clinical study indicate that after once daily use at night for two or three weeks, a tooth whitening gel containing 25% carbamide peroxide and a tooth whitening gel containing 8.7% hydrogen peroxide both provided statistically significant tooth shade lightening relative to baseline tooth shade. The results also showed that there was no statistical difference in tooth whitening efficacy between the two tooth whitening gel products. A double-blind, 3-week, randomized, placebo-controlled, parallel-group clinical trial was conducted to evaluate the tooth-whitening efficacy of a novel nontray, "paint-on" liquid whitening gel containing 18% carbamide peroxide (Colgate Simply White Clear Whitening Gel). Efficacy was based on measured Vita tooth-shade scores collected at baseline and after 2 and 3 weeks of product use. Eighty healthy volunteers were balanced into 2 groups based on gender, age, and shade scores (A3 or higher). The duration of product usage was 30 minutes, twice daily, for 3 weeks. Results from this clinical study showed that subjects' teeth in the liquid whitening gel-treated group exhibited an overall mean 3.84-shade improvement and a 3.5-shade difference compared with teeth in the placebo gel group (statistically significant, P < .05) after 3 weeks. Furthermore, this improvement exceeds the minimum requirement to claim "clinical efficacy" as established by the "Guidelines for the Acceptance of Peroxide-Containing Oral Hygiene Products," published by the American Dental Association in 1994. Therefore, it can be concluded that Colgate Simply White Clear Whitening Gel significantly whitens teeth. A three-cell, randomized, parallel, investigator-blinded clinical trial was conducted to compare the efficacy and safety of three professional at-home tooth whitening systems, including Crest Professional Whitestrips (6.5% H2O2), Day White 2 (7.5% H2O2) and Nite White Excel 2 (16% carbamide peroxide equivalent). Ninety subjects were randomly assigned to three groups (30/group). Subjects were instructed to use the assigned whitener following the manufacturers' instructions. Clinical examinations at baseline, and on days 3, 7, 14, and 18 (Day White), or 21 (Crest Professional Whitestrips and Nite White) included the following parameters: 1) oral tissues; 2) tooth shade by the Vitapan Classical shade guide; 3) tooth shade by a chromameter with a jig; and, 4) tooth sensitivity and gingival irritation. The results showed significant shade reductions with time in all three groups. Nite White resulted in significantly greater shade reductions in periods between days 7, 14, or 21 and baseline than did the other two systems. Tooth sensitivity and gingival irritation, which were mostly mild and transient, occurred in all groups. It is concluded that all three whitening systems evaluated are effective and safe. Nite White Excel is superior to the other two systems because it provides a greater whitening efficacy with comparable or lower incidence of tooth sensitivity and gingival irritation. A randomized and controlled, parallel-group clinical trial compared the whitening benefits of a novel 5.3% hydrogen peroxide bleaching strip to 10%, 15%, and 20% carbamide peroxide tray-based bleaching systems. A total of 36 healthy adults were randomized to a 14-day regimen in which both arches were whitened for 1 hour per day in the whitening-strip group or 2 hours per day in the tray groups. Efficacy was measured objectively using digital images of the anterior teeth at baseline and after 14 days of treatment. Overall tooth color (L*a*b*) was derived from individual pixel values, and then mean levels of delta b*, delta L*, and composite color (delta E*) were compared using analysis of covariance. After 14 days of treatment, all groups experienced a greater than 1-unit mean improvement in delta b*, delta L*, and delta E* relative to baseline. For the primary study variable, reduction of yellow (delta b*) outcomes after 14 hours of using the experimental strip were comparable to those observed with the 10% tray group after 28 hours of use. These two treatment groups did not differ statistically with respect to any of the color measurements used in this study. For the tray groups, there was a reasonable dose relationship for the primary end point, delta b*, with the 15% and 20% tray groups averaging 17% and 68% improvements in yellow, respectively, over the 10% group. Except for the 20% carbamide peroxide system, where sensitivity was relatively common, all test products were well tolerated. In this first comparative evaluation vs marketed controls, use of the whitening strips twice daily for 14 days yielded a highly significant improvement in tooth color vs baseline. Bleaching offers a non-interventive way of improving the appearance of sound, yet discolored anterior teeth. Until recently, the whitening agent was applied using a tray, but now other methods of delivering whitening agents, such as those using brush applicators, are available. This study investigated the tooth whitening efficacy of two novel, self-applied tooth whitening systems containing either 18% (Group 1) or 16.4% (Group 2) carbamide peroxide. Ninety-five subjects, ranging in age from 18 to 70 with anterior teeth A3 or darker, were recruited and randomly allocated to a group. The subjects were instructed to apply the formulation to all maxillary anterior teeth after brushing in the morning and evening. At baseline, two weeks and six months the upper six anterior teeth of the subjects were measured using the Vita shade guide tab system. In addition, the gingival health of the labial surfaces of the upper six anterior teeth was assessed using the Loee and Silness Gingival index (Loee & Silness, 1963) at baseline and at two weeks. The mean (SD) reduction in shade guide scores was 4.1 (2.4) shade guide tabs for subjects in Group 1, compared to 3.7 (2.6) shades for those in Group 2. This difference was not statistically significant (p=0.5). During the course of study, the gingivitis scores reduced from a mean (SD) of 0.91 (0.62) at baseline to 0.44 (0.55) at final examination (48% reduction). At the six-month recall, the mean (SD) reduction in shade guide scores was 2.3 (2.7) shade guide tabs for subjects in Group 1, compared to 2.5 (2.5) shades for those in Group 2. The different concentrations tested were found to be equally effective in improving the whiteness of upper anterior teeth by approximately four shades over a two-week period and the majority of the whitening benefit (c.60%) was sustained at six-month recall. To compare the whitening effectiveness of two professional vital bleaching systems in a randomized clinical trial.
                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.
                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. A randomized, single-center, double-blind, parallel-group, placebo-controlled trial evaluated the whitening efficacy and safety of 2-week, twice-daily use of a 5.3% hydrogen peroxide tooth-bleaching gel delivered on polyethylene film. Efficacy was based on change in Vita shade scores from baseline to the end of treatment. Thirty-three patients in each group completed treatment. Use of the peroxide-containing gel led to a mean change in baseline Vita shade score of -3.70 +/- 0.35, compared with a change of -0.87 +/- 0.24 after use of a placebo gel. After adjustment for baseline scores, the mean difference in shade change between the peroxide gel-treated group and placebo-treated group was -2.85 +/- 0.41 (P < 0.0001). Both treatments were generally well tolerated. The strips offer ease of use, comfort, and shorter duration of wear compared with other at-home bleaching systems. To directly compare tooth color change and spatial uniformity of two brush-applied, peroxide-based overnight tooth whiteners in a 2-week randomized clinical trial.
                57 adult volunteers were randomly assigned to Crest Night Effects, a 19% sodium percarbonate system packaged in unit dose sachets that when applied, dries to form an adherent film, or Colgate Simply White Night, a paint-on liquid in an applicator bottle at a concentration of 8.7% hydrogen peroxide. Both groups applied their assigned gel on the facial surfaces of the six maxillary anterior teeth for 14 nights. Efficacy was measured objectively as change in L*a*b* tooth color from standard digital images of maxillary teeth, while safety was evaluated by clinical examination and interview.
                After 14 nights treatment, adjusted mean (SE) change in yellowness (delta b*) was -0.95 (0.092) for the 19% sodium percarbonate film and -0.17 (0.096) for the 8.7% hydrogen peroxide gel, with these groups differing statistically (P < 0.0001). Other individual and composite color parameters also demonstrated significantly greater whitening for the 19% sodium percarbonate film compared to the 8.7% hydrogen peroxide gel after 14 nights use. Only the 19% sodium percarbonate film exhibited significant (P< 0.0001) proximal color improvement (delta b*) after 2 weeks, approximately 98% of that seen on the body of the tooth, providing evidence of proximal bleaching and uniform spatial whitening following use of this barrier-free system. Both products were well-tolerated, with no subjects discontinuing treatment early due to a causal adverse event. To compare the clinical response of two self-directed vital bleaching systems under market use conditions.
                A randomized, parallel-group clinical trial was conducted. A total of 20 healthy adults were randomized to either a 6.0% hydrogen peroxide strip-based bleaching system or a combination system involving a 10% carbamide peroxide gel in a stock tray along with an anticavity whitening dentifrice and after-bleaching whitening mouthrinse. Only the maxillary arch was bleached over a 14-day period. Subjects were evaluated at 3, 8 and 15 days. Efficacy was measured objectively using digital image analysis to derive individual color parameters (L*a*b*) and overall color change (deltaE*).
                After 14 days, the adjusted mean reduction in yellow (Ab*) was -2.23 +/- 0.157 for the whitening strips compared to -0.97 +/- 0.188 for the combination system. This represented a highly statistically significant (P< 0.0001), two-fold superior reduction in yellowness for the whitening strip group compared to the marketed control. Similar results were seen for other color parameters, with the whitening strip group exhibiting two-fold color improvement relative to the tray/dentifrice/rinse combination. With respect to tolerability, tooth sensitivity and oral irritation were the most common findings. Considering event duration and severity, median bleaching tolerability severity-days scores were 0.07 and 0.58 for the strip and combination systems respectively, with these treatments differing statistically (P= 0.04 1) favoring the whitening strips. The purpose of this study was to evaluate the degree of color change, any rebound effect, and sensitivities associated with using 2 different concentrations of carbamide peroxide in vivo.
                Twenty-five subjects used 10% and 15% agents in trays for 14 days on different sides of their maxillary arches. Subjects returned in 3 days and at 1, 2, 3, and 6 weeks for evaluation of color change and rebound effect. Shade matching, photographic means, and a colorimeter were used for evaluation. Subjects self-reported gingival and tooth sensitivity on a scale of 1 (no sensitivity) to 5 (severe sensitivity).
                After 2 weeks, delta L*, delta a*, delta b*, delta E* and delta shade guide rank means for the 10% whitening agent were 6.50, -1.37, -4.63, 8.79, and -15.40, respectively; for the 15% agent, they were 8.72, -1.63, -5.90, 11.03, and -16.59, respectively. After 6 weeks, delta L*, delta a*, delta b*, delta E*, and delta shade guide rank means for the 10% whitening agent were 3.04, -0.99, -3.19, 5.13, and -13.13, respectively; for the 15% agent, they were 3.48, -1.01, -3.60, 5.58, and -13.65, respectively. Means for gingival sensitivity were 1.18 and 1.21 for the 10% and 15% agents, respectively; means for tooth sensitivity were 1.21 and 1.26 for the 10% and 15% agents, respectively.
                All 3 methods of evaluation revealed a significant difference in the tooth lightness achieved by 10% and 15% products at 2 weeks but no significant difference at 6 weeks. No statistically significant difference was found in gingival or tooth sensitivity. 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.
                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).
                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. Agents with carbamide peroxide, or CP, in various concentrations are widely prescribed for at-home tooth whitening. It is not clear, however, if the more concentrated gels will whitening teeth to a greater extent, as no controlled clinical trials have been reported. The authors conducted a double-blind study of human subjects to evaluate whether a 15 percent CP tooth-whitening system was more effective than a 10 percent CP system, and to determine if tooth sensitivity increased with use of the higher concentration.
                The authors recruited 57 subjects with maxillary anterior teeth of shade A3 or darker (as gauged against a value-oriented shade guide). The subjects were 18 to 65 years of age and in good general and dental health. After matching the subjects by sex and age, the authors randomly assigned them to either a control group, which used a 10 percent CP whitening agent, or an experimental group, which used a 15 percent CP agent.
                The results indicated that there was no significant difference in shade change between the groups after one week of treatment (t = 1.455, P = .05), but there was a significant difference at the end of the treatment period (t = 2.303, P < .05), as well as two weeks after treatment concluded (t = 2.248, P < .05). There was no significant difference in sensitivity (t = 1.399, P > .05).
                There was a significant difference in color change between the 10 percent CP and 15 percent CP groups at the end of the study period. There was no significant difference in level of tooth sensitivity between the two groups, and the incidence was equal; there was, however, a significant difference in variability of tooth sensitivity between the two groups.
                If performed under the careful guidance of a dentist, at-home whitening is an effective treatment, regardless of whether 10 percent CP or 15 percent CP is used. There may be added color change and varying sensitivity with the use of 15 percent CP. 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.
                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.
                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."
                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.
                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. A 2-week study was conducted to compare the tooth-whitening efficacy of two 10% carbamide peroxide products: Colgate Platinum Professional Toothwhitening System and Rembrandt Lighten Bleaching Gel. Fifty subjects were divided into two groups and assigned a product to use for 2 weeks. Change in tooth color was measured by reflectance spectroscopy at the initiation of study, at 1 week, and at 2 weeks into the study. Color change was calculated using the color-difference equation established by the Commission International de L'Eclairage. Results showed that Colgate Platinum was 62% more effective at tooth whitening after 1 week and 83% more effective after 2 weeks of treatment vs Rembrandt. At the termination of the study, the mean color difference (deltaE) for Colgate Platinum was 4.29 and 2.34 for Rembrandt. Statistical analysis demonstrated that the Colgate product is significantly superior at increasing tooth whiteness, increasing tooth lightness, reducing redness, and reducing yellowness. In this study, no adverse reactions were noted on clinical examination and none were reported by panelists with normal healthy dentition. The effect of reducing the abrasivity of toothpaste on dental caries was observed in a 3-year clinical trial involving 1106 11-13-year-old Berkshire schoolchildren were divided into three groups; Group 1 were allocated a low abrasivity paste containing 0.8% sodium monofluorophosphate, Group 2 a paste of conventional abrasivity also containing 0.8% sodium monofluorophosphate and Group 3 a low abrasivity non-fluoride paste. After 3 years the net DMFS increments (clinical and radiographic scores combined) were 4.22 in Group 1, 4.72 in Group 2 and 6.43 in Group 3. The differences between Groups 1 and 3 and between Groups 2 and 3 were highly significant (P less than 0.001). The mean increment in Group 1 was lower than in Group 2 but did not reach statistical significance. Reducing the abrasivity of the toothpaste had no meaningful effect on the standard of oral hygiene and prevalence of gingivitis as measured by the Gingival and Plaque Indices. The objective of this examiner-blind clinical study was to investigate the efficacy of three oral hygiene regimens for the control of gingivitis and supragingival plaque.
                Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the San Francisco, California area were stratified into three treatment groups, which were balanced for plaque. The groups were then randomly assigned to one of three oral hygiene regimens: 1) twice-daily tooth brushing with Colgate Total Toothpaste, accompanied by once-daily flossing after brushing; 2) twice-daily tooth brushing with Colgate Total Toothpaste without flossing; and 3) twice-daily tooth brushing with a sodium fluoride toothpaste, accompanied by once-daily flossing after brushing. All subjects were given a complete oral prophylaxis, and dispensed their assigned treatment product(s), along with a soft-bristled adult toothbrush for home use. All dentifrice products were supplied in the original packaging to which overwrapping had been applied. Subjects were instructed to brush their teeth for one minute twice daily (morning and evening) using only the dentifrice provided, and to refrain from using anything other than their assigned oral hygiene products for the duration of the study. In addition, subjects were instructed to refrain from any routine dental treatment (except emergency) during the course of the study. There were no restrictions regarding diet or smoking habits over the course of the study. Examinations for gingivitis and supragingival plaque, and oral soft tissue assessments were repeated after three months, and again after six months of product use.
                One-hundred fourteen (114) subjects complied with the protocol and completed the six-month examinations. Statistical analyses showed similar results for both whole-mouth and interproximal scoring sites after six months of product use. Although not statistically significant, subjects using Colgate Total Toothpaste accompanied by the use of dental floss had numerically lower six-month scores for gingivitis and supragingival plaque formation when compared to the scores of subjects using Colgate Total Toothpaste without the use of dental floss. Relative to the sodium fluoride toothpaste accompanied by the use of dental floss, subjects using Colgate Total Toothpaste, both with and without the use of dental floss, exhibited statistically significant reductions in gingivitis and supragingival plaque formation after six months of product use.
                The results of this clinical study support the conclusion that the use of Colgate Total Toothpaste, both with and without the use of dental floss, provided statistically significant improvements over the sodium fluoride toothpaste plus flossing regimen with respect to the control of gingivitis and supragingival plaque formation. Although not statistically significant, numerically lower six-month scores for gingivitis and supragingival plaque were associated with Colgate Total Toothpaste accompanied by the use of dental floss, when compared with Colgate Total Toothpaste without the use of dental floss. The purpose of this study was to examine the effects of various product combinations involving brush, paste, rinse, and floss on the prevention of plaque regrowth and gingivitis.
                In this randomized, parallel-group, examiner-blind, eight-week study, 179 subjects with gingivitis had a dental prophylaxis and were randomly assigned to one of six product combinations: 1) Colgate Wave manual toothbrush + Colgate Total dentifrice (0.3% triclosan/copolymer dentifrice); 2) Wave + Total + Listerine (essential oils rinse); 3) Oral-B CrossAction manual toothbrush + Crest Pro-Health dentifrice (0.454% stannous fluoride/sodium hexametaphosphate); 4) CrossAction + Pro-Health dentifrice + Crest Pro-Health Rinse (0.07% cetylpyridinium chloride rinse); 5) Oral-B ProfessionalCare Series 8000 power toothbrush + Pro-Health dentifrice; or 6) ProfessionalCare power brush + Pro-Health dentifrice + Oral-B Hummingbird power flosser. Subjects used their test products for the duration of the study. Whole mouth plaque, gingivitis, and product-related adverse events were assessed. Treatments were compared at a 0.05 level of significance.
                One-hundred and seventy-four subjects completed the study and were included in the data analysis. At Week 8, the overnight adjusted whole mouth plaque scores were statistically significantly lower in all other groups relative to the Wave + Total group (p < or = 0.030). Plaque scores were also statistically significantly lower (approximately 20%) in both groups where a therapeutic rinse was added to a manual brush and therapeutic paste relative to scores for the brush plus paste without a rinse (p < or = 0.034). All groups showed a reduction in gingivitis at Week 4, and mean scores remained stable or increased slightly at Week 8. The power toothbrush groups were directionally better at preventing gingivitis than the manual groups at Weeks 4 and 8.
                Reductions in overnight plaque were seen when therapeutic rinses were added to manual brush plus therapeutic dentifrice regimens above that observed with a manual brush and therapeutic dentifrice alone. A randomized prospective clinical study, with 220 patients scheduled for fixed orthodontic therapy, was conducted to test the hypothesis that application of an antimicrobial varnish in combination with a fluoride varnish (group 1) is significantly more efficient in reducing white spot lesions on the labial surfaces than application of the fluoride varnish alone (group 2). The effects of the antimicrobial varnish on the occurrence of gingivitis and plaque formation were also studied. A third aim was to investigate whether white spot lesion development could be predicted early during treatment. The antimicrobial varnish significantly reduced the number of mutans streptococci in plaque during the first 48 weeks of treatment. This effect did not result in significantly less development of white spot lesions on the labial surfaces compared with the group receiving only the fluoride varnish application. There was however a clear trend that the combination of the antimicrobial and fluoride varnishes more effectively reduced the increments of new lesions on the maxillary incisors. It was speculated that this could be due partly to an inhibiting effect of the antimicrobial varnish in an area with low oral clearance (with low pH and loss of fluoride) and partly to an inhibiting effect of the varnish on mutans streptococci. No significant differences between the groups with respect to gingivitis and plaque were found. Lesion development was difficult to predict early after bonding, despite a number of caries-relevant parameters of orthodontic importance. The best predictors for white spot lesions at debonding were visible plaque and mutans streptococci (eg, the level of oral hygiene and thus the cariogenic challenge) around the appliance shortly after bonding. The aim of this randomized, double-blind study was to measure the cariostatic effect of Bifluorid 12 (VOCO GmbH), containing 6% sodium fluoride and 6% calcium fluoride and Laweflour-Schüttellack (LAW), containing 5% sodium fluoride in comparing of placebo varnish. The caries study included 400 schoolchildren, aged 12-14 years. The tests according to the DMFS were carried out by two independent examiners. The 400 children were divided into 3 test and 1 placebo group, each group consisting of 100 subjects. After two years there was a significant inhibition of caries increment in all test groups compared to placebo group. Percentage caries reduction ranged from 25 to 30%. The highest effect was stated at proximal surfaces.
There is evidence that whitening products work when compared with placebo/no treatment. There are differences in efficacy between the products, mainly due to the levels of active ingredients, hydrogen peroxide and carbamide peroxide. All trials were however short term and the majority of the studies were judged to be at high risk of bias and were either sponsored or conducted by the manufacturers. There is a need for pragmatic long-term and independent clinical studies that include participants representing diverse populations. There is also a need to evaluate long-term harms. Several studies reported (where measured) the common side effects of tooth sensitivity and gingival irritation, and people should be informed of this.