美白牙贴洁白牙齿的有效性和安全性临床观察

目的评价含10%过氧化氢的美白牙贴对牙齿的美白效果和安全性。方法采用双盲、单中心的临床研究方法。根据数字成像系统记录的上前牙的牙齿颜色、性别和年龄将54名研究对象随机地分为两组,使用实验和对照牙贴,每天两贴,每贴30分钟,7天共用14贴。于基线、使用牙贴第9天,检查研究对象数字成像系统记录的牙齿颜色变化、口腔软组织的健康状况。结果共有50名研究对象完成了该研究。7天使用14贴牙贴后:实验组使用牙贴后与使用前比较,牙齿各项颜色指标都有明显变化(P<0.001),其中△b*值为-1.96±0.085,△L*值为2.16±0.136;实验组与对照组比较,各项颜色指标也都有显著改变(P<0.001),其中△b*的组间差值为-1.75±0.118,△L*的组间差值为1.87±0.154。牙齿的白度(b*)和亮度(L*)都有明显改善,差异具有明显统计学意义。实验组有轻度口腔黏膜刺激症状的占16%,有牙本质过敏症状的占60%,这些不良反应都在停用产品2周内基本消失。结论7天使用14贴含10%过氧化氢的美白牙贴,能使牙齿明显亮白,没有明显不良反应。     

Vital bleaching: a new light-activated hydrogen peroxide system.

With ever increasing interest in cosmetic enhancement of dentition by dentists and patients alike, this article introduces a new light-activated bleaching system that adds up to total patient satisfaction and reduced chair time. The chairside application of hydrogen peroxide 30% was effective in lightening a moderate case of tetracycline staining. The uniqueness of this system allows the practitioner complete control within an office setting, and it provides the patient with an immediate result. The ease of application and strict supervision of a dentist has allowed this system to satisfy recent watchdogs of the Federal Drug Administration.     

Manganese oxide increases bleaching efficacy and reduces the cytotoxicity of a 10% hydrogen peroxide bleaching gel

Clinical Oral Investigations - The study aims to assess the effects of a 10% H2O2 bleaching gel with different MnO2 concentrations on the bleaching efficacy (BE), degradation kinetics (DK) of H2O2,...     

Professional vital bleaching using a thin and concentrated peroxide gel on whitening strips: an integrated clinical summary

Rapid innovation in vital bleaching continues to expand the number of treatment options available to patients, particularly in the area of at-home whitening. The development of bleaching strips represented a new paradigm in the delivery of peroxide. The efficacy and safety of bleaching strip systems delivering up to 6.5% hydrogen peroxide has been established in numerous randomized clinical trials. In 2003, a novel bleaching strip with 14% hydrogen peroxide (Crest Whitestrips Supreme) was introduced. This advanced system carries a thinner but more concentrated gel on each strip, resulting in a relatively similar total amount of peroxide as compared to other strip systems. This 2-variable change, higher concentration gel with lowered gel volume translates to improved whitening without adversely affecting oral soft tissue tolerability and irritation. This paper provides an integrated review of 9 comparative clinical trials evaluating the whitening response (six trials) and safety (nine trials) of this novel vital bleaching system. Efficacy results for the 14% hydrogen peroxide strips were significantly (p<0.05) better than the placebo or pooled positive controls evaluated in the clinical trials assessing tooth color or shade. Adverse events were similar in type to the other vital bleaching systems. Overall, the research of 408 patients showed generally better efficacy and similar to or better tolerability for the 14% hydrogen peroxide strips compared to a selected group of marketed positive bleaching controls.     

Efficacy and safety assessment of a new liquid tooth whitening gel containing 5.9% hydrogen peroxide

PURPOSE: To evaluate the efficacy and safety of a new 5.9% hydrogen peroxide liquid, invisible gel, (Colgate Simply-White Whitening Gel). METHODS: A total of 30 subjects were enrolled into the study and divided into two treatment groups (Colgate vs. placebo gel). Efficacy was assessed using VITA shade scores and safety evaluations were performed including the examination of plaque index (PI), bleeding index (BOP), gingival recession and dentin hypersensitivity. Statistical analysis was performed to determine the mean change from baseline. RESULTS: The new whitening gel containing 5.9% hydrogen peroxide was significantly effective in lightening tooth shade. After only 2 weeks, patients enrolled in the study exhibited an overall mean 4.48-shade improvement from baseline, which was significantly greater than placebo group and far exceeded the ADA minimum requirements to claim "clinical efficacy". In the new Colgate Simply White Clear Whitening Gel group, periodontal health (PI and BOP) improved with time overall. Moreover, dentin hypersensitivity did not significantly increase, and all treatments were generally well tolerated. CLINICAL SIGNIFICANCE: The new Colgate Simply White whitening gel containing 5.9% hydrogen peroxide allowed consistent bleaching using minimal contact time, without adversely impacting overall tolerability.     

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.     

Single site meta-analysis of 6% hydrogen peroxide whitening strip effectiveness and safety over 2 weeks

Objectives

This research evaluated efficacy and safety of 6% hydrogen peroxide whitening strips from a clinical trials database accumulated over a multi-year period at a single site.

Methods

The inclusive meta-analysis involved seven different randomized clinical trials at one dental school. Each study used 6% hydrogen peroxide whitening strips twice daily for 30 min over a 2-week period. Common efficacy (digital images) and safety (examination and interview) methods were used across studies. Pooled subject-level data were analyzed using a general linear mixed model to determine overall response and effects of treatment duration on whitening.

Results

The 148 treated subjects were 18–71 years old, with b* (yellowness) ranging from 12 to 22, and L* (lightness) ranging from 69 to 80. After 1-week strip use, the adjusted mean (S.E.) for Δb* was −1.6 (0.08), differing significantly from baseline (p < 0.0001). After 2 weeks, the adjusted mean (S.E.) for Δb* was −2.3 (0.07), differing significantly from Week 1 (p < 0.0001). The estimated correlation between Weeks 1 and 2 for Δb* was 0.74. Study-to-study variation contributed less than 2% of Δb* variability. Results were similar for ΔL*, with Weeks 1 and 2 estimated means (S.E.) of 1.5 (0.13) and 2.0 (0.12). Occurrence of oral irritation (22%) and tooth sensitivity (20%) did not adversely affect whitening. Other side effects were unremarkable, and only 1 subject (0.7%) discontinued treatment early due to an adverse event.

Conclusions

The meta-analysis of multiple studies conducted at a single clinical site over several years establishes consistent, effective and safe vital bleaching with 6% hydrogen peroxide whitening strips.     

Concentrations of and application protocols for hydrogen peroxide bleaching gels: Effects on pulp cell viability and whitening efficacy

Objectives

To assess the whitening effectiveness and the trans-enamel/trans-dentinal toxicity of experimental tooth-bleaching protocols on pulp cells.

Methods

Enamel/dentine discs individually adapted to trans-well devices were placed on cultured odontoblast-like cells (MDPC-23) or human dental pulp cells (HDPCs). The following groups were formed: G1 – no treatment (control); G2 to G4 – 35% H₂O₂, 3 × 15, 1 × 15, and 1 × 5 min, respectively; and G5 to G7 – 17.5% H₂O₂, 3 × 15, 1 × 15, and 1 × 5 min, respectively. Cell viability and morphology were evaluated immediately after bleaching (T1) and 72 h thereafter (T2). Oxidative stress and cell membrane damage were also assessed (T1). The amount of H₂O₂ in culture medium was quantified (Mann–Whitney; α = 5%) and colour change (ΔE) of enamel was analysed after 3 sessions (Tukey's test; α = 5%).

Results

Cell viability reduction, H₂O₂ diffusion, cell morphology alteration, oxidative stress, and cell membrane damage occurred in a concentration-/time-dependent fashion. The cell viability reduction was significant in all groups for HDPCs and only for G2, G3, and G5 in MDPC-23 cells compared with G1. Significant cell viability and morphology recovery were observed in all groups at T2, except for G2 in HDPCs. The highest ΔE value was found in G2. However, all groups presented significant ΔE increases compared with G1.

Conclusion

Shortening the contact time of a 35%-H₂O₂ gel for 5 min, or reducing its concentration to 17.5% and applying it for 45, 15, or 5 min produce gradual tooth colour change associated with reduced trans-enamel and trans-dentinal cytotoxicity to pulp cells.

Clinical significance

The experimental protocols tested in the present study provided significant tooth-bleaching improvement associated with decreased toxicity to pulp cells, which may be an interesting alternative to be tested in clinical situations intended to reduce tooth sensitivity and pulp damage.     

In vivo kinetics of bleaching gel with three-percent hydrogen peroxide within the first hour

This in vivo study determined the kinetics of 3% hydrogen peroxide in a bleaching gel within the first hour. The material used in this study was 3% hydrogen peroxide gel (Perfecta 3/15, Premier Dental Products Co) and the study involved 10 subjects who met the inclusion and exclusion criteria. Each subject wore the tray with gel six different times on separate days. Evaluation of the remaining amount of hydrogen peroxide was calculated by the method stated in US Pharmacopoeia. The study results indicate that the mean percentage of hydrogen peroxide recovered for 5, 10, 20, 30, 45 and 60 minutes was 61, 56, 49, 44, 38 and 32, respectively. The amount of hydrogen peroxide in the saliva sample after one hour was 0.42 mg. Excluding the first 10 minutes, the kinetics of hydrogen peroxide in the tray and teeth sample was exponential.     

Vital bleaching with whitening strips: summary of clinical research on effectiveness and tolerability

Rapid innovation in vital bleaching has increased the popularity of tooth whitening among dental professionals and patients. A broad range of peroxide-based treatments are currently available including those that are professionally-administered (in-office), professionally-dispensed (custom-tray-based systems), and self-directed (over-the-counter). Recently, a novel, flexible polyethylene bleaching strip was introduced that delivers a hydrogen peroxide bleaching gel to the anterior dentition. This "trayless" system, available in professional-strength and over-the-counter versions, reportedly offers advantages with respect to overall peroxide dose, contact time, and ease-of-use compared to other delivery systems. This paper reviews the relevant published clinical research on whitening strips tested among a broad range of patients commonly encountered in contemporary dental practices.     

Comparative tooth whitening efficacy of 18% carbamide peroxide liquid whitening gel using three different regimens

OBJECTIVE: 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. METHODOLOGY: 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. RESULTS: 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. CONCLUSION: 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.     

A 180-day clinical investigation of the tooth whitening efficacy of a bleaching gel with added amorphous calcium phosphate

OBJECTIVE: The purpose of this study was to determine if there are any significant long-term clinical benefits, or side effects, caused by the addition of amorphous calcium phosphate (ACP) to a professional, 16% peroxide bleaching gel. METHODOLOGY: This study examined the effect of bleaching gel with added ACP in a subset of subjects (n=27) from a previously published, short-term (n=50) study, in which two groups were assigned to use either an experimental ACP-containing gel or a similar "control" gel. Both groups used the product for four hours (or overnight) daily for 14 days. In the present study, the long-term ACP effects on tooth color, gingival health, and three measures of dentinal hypersensitivity at post-treatment days +90 and +180 were assessed. RESULTS: In the previously published study, at day +five, the difference in tooth whitening efficacy (relative to baseline) between the test group and the control group was only 0.19 shades and was not statistically significant. In the present study, at day +90, the differences between the groups had almost doubled, and were calculated to be 0.34 shades (statistically different; t-test p = 0.002). Furthermore, at day +180, the differences had more than doubled again, with the ACP group subjects' teeth being 0.78 shades lighter than the control group's teeth (statistically different; t-test p = 0.002). Considered as a percentage, at day +180 the ACP group had retained nearly 10% more of their original whitening treatment result compared to control. There were no other significant differences found between the two groups. Tooth sensitivity, soft tissue health, and gingival health remained similar to baseline levels. CONCLUSIONS: This study demonstrated that the ACP product offers 10% better long-term (6-months) whitening efficacy than the traditional bleaching gel tested. The long-term safety of the product has also been demonstrated, as there were no adverse gingival or other effects seen at either day +90 or day +180.     

At-home vital bleaching: a comparison of hydrogen peroxide and carbamide peroxide treatments

Tray bleaching of vital teeth performed at home by the patient under the dentist s supervision, whether alone or in combination with any of the in-office techniques, provides an interesting alternative to other methods employed in this type of dental treatment. This bleaching procedure applies low-concentration peroxides to the enamel by means of a custom-made mouth tray specifically designed for this purpose. The aim of this study is to examine and compare two commercially-available bleaching products, at equivalent concentrations, for use in this technique: VivaStyle (Vivadent) and FKD (Kin); the former is a 10% carbamide peroxide and the latter a 3.5% hydrogen peroxide formulation. It examines the parameters that must be monitored during the application of this type of procedure and presents 6 cases (3 treated with one of the above-mentioned products and the other 3 with the other), establishing the bleaching power of the products and the appearance and intensity of post-operatory hypersensitivity. The results obtained show that both products are effective for the purpose for which they were designed. In general, dental hypersensitivity was minimal.     

Bleaching effectiveness,hydrogen peroxide diffusion,and cytotoxicity of a chemically activated bleaching gel

Objectives

The objective of this study was to evaluate the bleaching effectiveness, hydrogen peroxide diffusion (H₂O₂), and cytotoxicity of a bleaching gel with 35 % H₂O₂ either associated with ferrous sulfate (FeSO₄) or not.

Materials and methods

Enamel/dentin discs adapted to artificial pulp chambers were placed in compartments containing a culture medium (Dulbecco's Modified Eagle's Medium (DMEM)) and distributed into the following groups: G1—no treatment (negative control), G2—10 % carbamide peroxide (one application for 4 h), G3—35 % H₂O₂ (three applications for 15 min), and G4—35 % H₂O₂ + 0.004 g FeSO₄ (three applications for 15 min). After treatments, the extracts (DMEM + bleaching components that diffused across enamel and dentin) were applied on human dental pulp cells (HDPCs) and odontoblast-like cells (MDPC-23). Cell viability (MTT assay, Kruskal–Wallis and Mann–Whitney, α?=?5 %), quantification of H₂O₂ diffusion, and color change of the enamel/dentin discs (Commission Internationale de I'Eclairage L*a*b* system) were assessed (analysis of variance and Tukey's tests, α?=?5 %).

Results

For both cells, a significant reduction in cell viability was observed for G3 and G4 compared with G1 and G2. No statistical difference was observed between G3 and G4. The rate of H₂O₂ diffusion was significantly higher in G3 compared with that in G2 and G4. The ΔE value for G4 was statistically higher than that of the other groups.

Conclusions

Chemical activation of H₂O₂ by FeSO₄ improves the bleaching effectiveness. However, this metal ion has no significant protective effect against pulp cell cytotoxicity.

Clinical relevance

Although the chemical activation of H₂O₂ by adding FeSO₄ to the bleaching agent improved the bleaching effectiveness, this metal ion has no significant protective effect against pulp cell cytotoxicity.