Evaluation of At-home Bleaching Times on Effectiveness and Sensitivity with 10% Hydrogen Peroxide: A Randomized Controlled Double-blind Clinical Trial

2021 ◽  
Author(s):  
K Chemin ◽  
M Rezende ◽  
MC Costa ◽  
ADY Salgado ◽  
JL de Geus ◽  
...  

SUMMARY Objectives: The aim of this randomized double-blind controlled clinical trial was to evaluate different protocols for at-home use of 10% hydrogen peroxide in whitening effectiveness and tooth sensitivity. Methods: Seventy-two patients were selected according to the inclusion and exclusion criteria, with the upper central incisors having color A2 or darker according to the Vita Classical scale (VITA Zahnfabrik, Bad Säckingen, Germany) and randomized into two groups: 10% hydrogen peroxide applied once daily for 15 minutes (HP 15) or applied once daily for 30 minutes (HP 30). Bleaching was performed for 14 days in both groups. The color was evaluated before bleaching, during bleaching (1st and 2nd weeks), and 1 month after the bleaching treatment using the Vita Classical, Vita Bleachedguide 3D-MASTER, and Vita Easyshade spectrophotometer (VITA Zahnfabrik). Dental sensitivity was recorded by the patients using the numerical rating scale (0–4) and visual analogue scale (0-10 cm). Color data were evaluated by two-way analysis of variance (ANOVA) of repeated measures (group vs. treatment time). The Mann-Whitney test was performed to contrast the means (α=0.05). Tooth sensitivity was assessed by Fisher’s exact test (p=1.00) and intensity of tooth sensitivity was evaluated by the Mann-Whitney test (α=0.05) for both scales. Results: A significant whitening effect was observed after 2 weeks of bleaching for all color measurements (p=0.01), with no difference between HP 15 and HP 30 (p>0.05). Also, the absolute risk and intensity of tooth sensitivity were similar (47%; p>0.05). Conclusions: The effectiveness and tooth sensitivity of at-home bleaching carried out with 10% hydrogen peroxide applied for 15 minutes or 30 minutes are similar.

2018 ◽  
Vol 43 (3) ◽  
pp. 232-240 ◽  
Author(s):  
K Chemin ◽  
M Rezende ◽  
AD Loguercio ◽  
A Reis ◽  
S Kossatz

SUMMARY Objectives: To evaluate the risk for and intensity of tooth sensitivity and color change of at-home dental bleaching with 4% and 10% hydrogen peroxide (HP). Methods: For this study, 78 patients were selected according to the inclusion and exclusion criteria and randomized into two groups: HP 4 (White Class 4%, FGM) and HP 10 (White Class 10%, FGM). In both groups, the at-home bleaching was performed for a period of 30 minutes twice a day for two weeks. The color was assessed by Vita Classical, Vita Bleachedguide 3D-MASTER and spectrophotometer Vita Easyshade (Vita Zahnfabrik) at baseline, during bleaching (first and second weeks) and after bleaching (one month). Patients recorded their tooth sensitivity using a numeric rating scale (0-4) and visual analog scale (0-10). Data from color change (DeltaE data) was submitted to two-way analysis of variance. The color change data in Delta SGU from the two shade guide units were compared with the Mann Whitney test. The risk of tooth sensitivity was evaluated by χ2 test and the intensity of tooth sensitivity from both scales was evaluated by a Mann-Whitney test (α=0.05). Results: The absolute risk and intensity of tooth sensitivity was higher in the group that used HP 10 than the one that used HP 4. Data from change in the number of shade guide units and color variation after one month of bleaching for both groups showed significant whitening, with no difference between groups. Conclusions: At-home bleaching is effective with 4% and 10% HP concentrations, but 10% HP increased the absolute risk and intensity of tooth sensitivity during at-home bleaching.


2021 ◽  
Vol 32 (3) ◽  
pp. 105-115
Author(s):  
Karine Letícia da Silva ◽  
Elisama Sutil ◽  
Diego Hortkoff ◽  
Renata Maria Oleniki Terra ◽  
Márcia Rezende ◽  
...  

Abstract This clinical trial evaluated the effect of the coadministration of ibuprofen/caffeine on bleaching-induced tooth sensitivity (TS). A triple-blind, parallel-design, randomized clinical trial was conducted on 84 patients who received ibuprofen/caffeine or placebo capsules. The drugs were administered for 48 hours, starting 1 hour before the in-office bleaching. Two bleaching sessions were performed with 35% hydrogen peroxide gel with 1-week interval. TS was recorded up to 48 hours after dental bleaching with a 0-10 visual analogic scale (VAS) and a 5-point numeric rating scale (NRS). The color was evaluated with VITA Classical and VITA Bleachedguide scales (ΔSGU) and VITA Easyshade spectrophotometer (ΔE*ab and ΔE00). The absolute risk of TS in both groups was evaluated using Fischer's exact test. Comparisons of the TS intensity (NRS and VAS data) were performed by using the Mann-Whitney test and a two-way repeated measures ANOVA, respectively. The color alteration between the groups was compared with the Student's t test. The significance level was 5%. There was no statistically significant difference between the groups for the absolute risk of TS (p = 1.00) or for the intensity of TS (p > 0.05). A bleaching of approximately 7 shade guide units was observed on the Vita Classical and Vita Bleachedguide scales, with no statistical difference between the groups. It was concluded that coadministration of ibuprofen and caffeine did not reduce the absolute risk or intensity of TS and did not interfere with the efficacy of dental bleaching.


CNS Spectrums ◽  
2018 ◽  
Vol 23 (1) ◽  
pp. 102-103
Author(s):  
Robert Goldman ◽  
Lenard Adler ◽  
Thomas Spencer ◽  
Robert Findling ◽  
Seth C. Hopkins ◽  
...  

AbstractObjectivesOnce-daily dosing with dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, achieves stable plasma concentrations over 24 hours with once-daily dosing. This study evaluated dasotraline in children aged 6–12 years (NCT02428088).MethodsPatients were randomized 1:1:1 to 6 weeks of once-daily, fixed-dose dasotraline 2 or 4 mg/day, or placebo. The primary efficacy endpoint was change from baseline (CFB) at Week 6 in ADHD Rating Scale Version IV – Home Version (ADHD RS-IV HV) total score, using a mixed model for repeated measures (MMRM) in the intent-to-treat (ITT) population. Secondary endpoints included Clinical Global Impression-Severity (CGI-S) score and safety endpoints.ResultsThe mean age of 342 randomized patients was 9.1 [SD: 1.9] years; 66.7% were male. Overall, 79% of patients completed the study. In the ITT population (N=336), ADHD RS-IV HV total score improved significantly with dasotraline 4 mg/day vs placebo(least squares [LS] mean [SE] CFB at Week 6: –17.53 [±1.31] vs –11.36 [±1.29], respectively, p<0.001; effect size [ES]: 0.48). Inattentiveness and hyperactivity/impulsivity subscale scores significantly improved with 4 mg/day vs placebo at Week 6 (p=0.001, p=0.003, respectively). Improvement in CGI-S score was statistically significant with dasotraline 4 mg/day vs placebo(LS mean [SE] CFB at Week 6: –1.39 [±0.12] vs –1.04 [±0.12], respectively, p=0.040; ES: 0.29). No significant improvement was observed on the ADHD RS-IV HV total score and the CGI-S score for dasotraline 2 mg/day vs placebo. The most frequent treatment-emergent AEs (≥5% and higher than placebo) were (2 mg/day; 4 mg/day; placebo): insomnia (15.3%; 21.7%; 4.3%, all terms combined), decreased appetite (12.6%; 21.7%; 5.2%), weight loss (5.4%; 8.7%; 0%), irritability (3.6%; 7.0%; 6.0%), nasopharyngitis (0.9%; 5.2%; 0.9%), and nausea (0%; 5.2%; 2.6%).ConclusionsCompared with placebo, dasotraline 4 mg/day significantly improved ADHD symptoms in children, as assessed by ADHD RS-IV HV total score and inattentiveness and hyperactivity/impulsivity subscale scores. Dasotraline was generally well tolerated; most common AEs were insomnia, decreased appetite, weight loss and irritability.Funding AcknowledgementsStudy sponsored by Sunovion Pharmaceuticals Inc.


2019 ◽  
Vol 13 (1) ◽  
pp. 377-382
Author(s):  
Leandro Féliz-Matos ◽  
Ninoska Abreu-Placeres ◽  
Luis Miguel Hernandez ◽  
Carlos Ruiz-Matuk ◽  
Patricia Grau-Grullón

Background: The clinical evidence relate the effect of associating the in-office and at home vital tooth whitening, describing positive effects on tooth color change and reduction of dental sensitivity. Objective: The purpose of this randomized double-blind clinical trial was to evaluate the effect on the shortened application of in-office vital tooth whitening combined with different concentrations of at-home peroxides in the final tooth color change and dental sensitivity. Methods: Randomized double-blind clinical trial with 120 participants between 18-65 years, allocated in four tooth whitening treatment groups: G1= Carbamide Peroxide 10% + Hydrogen Peroxide 40%, G2= Carbamide Peroxide 15% + Hydrogen Peroxide 40%, G3= Carbamide Peroxide 20% + Hydrogen Peroxide 40%, G4= Hydrogen Peroxide 10% + Hydrogen Peroxide 40% was conducted. Tooth color was measured at baseline and dental sensitivity and tooth color change during and after treatment. Results: No statistical significant differences were found in tooth color change (superior arch p= 0.183 / inferior arch p= 0.374), and in dental sensitivity (p=0.268). Conclusion: Reducing the application time of in-office whitening, combined with in-home products was effective in improving the color. All groups resulted in identical final color change and dental sensitivity. Clinicaltrials.gov: NCT02682329 Available from: https://clinicaltrials.gov/ct2/show/NCT02682329?term=hydrogen+peroxide.


2018 ◽  
Vol 43 (2) ◽  
pp. E53-E63 ◽  
Author(s):  
FM Coppla ◽  
M Rezende ◽  
E de Paula ◽  
PV Farago ◽  
AD Loguercio ◽  
...  

SUMMARY Bleaching-induced tooth sensitivity (TS) is highly prevalent. Objective: This study aimed to determine if the combination of opioids and nonopioids analgesics (Tylex) may provide a better analgesic effect. Method: A triple-blind, parallel, randomized two-center clinical trial was conducted with 105 healthy patients who received either a placebo or a combination of acetaminophen/codeine. The first dose of Tylex 30 mg (acetaminophen 500 mg/codeine 30 mg) or placebo was administered one hour before the in-office bleaching (35% hydrogen peroxide), and extra doses were administered every six hours for 48 hours. The TS was recorded using a visual analog scale of 0 to 10 and a numeric rating scale of 0 to 4 in different periods: during bleaching, one hour up to 24 hours, and 24 hours up to 48 hours postbleaching. The color was measured before and one month after dental bleaching with a visual shade guide (Vita Classical), Vita Bleachedguide 3D-MASTER, and the spectrophotometer Vita Easyshade. The absolute risk of TS was evaluated using the Fisher exact test. Data of TS intensity with numeric rating scale of the two groups were compared with the Mann-Whitney U-test and the Friedman test, while data from the visual analog scale were evaluated by two-way repeated measures analysis of variance and the Tukey test for pairwise comparison. The color changes between groups were compared using the Student t-test (α=0.05). Results: No significant differences between the groups were observed in the risk and intensity of TS. The overall absolute risk of TS was approximately 96%. No significant differences between groups were observed in terms of color change (p&gt;0.05) for any scale. Conclusion: The use of an acetaminophen/codeine combination prior to in-office bleaching does not reduce the risk and intensity of bleaching-induced TS.


2021 ◽  
Author(s):  
RMO Terra ◽  
KL da Silva ◽  
L Vochikovski ◽  
E Sutil ◽  
M Rezende ◽  
...  

Clinical Relevance Although color change was slightly lower in a 3-week 30-minutes/day protocol, than in the 120-minute protocol, this could be compensated by an extra week of bleaching. The advantage of the shorter protocol is the reduced daily application, making the procedure more comfortable for the patients. SUMMARY Objective: Compare the risk/intensity of tooth sensitivity (TS) and color change of a 30-minute vs. the recommended 120-minute application time of 4% hydrogen peroxide (HP) for at-home bleaching. Methods: A single-blind, parallel, randomized clinical trial was conducted with 92 adult patients with caries and restoration-free anterior teeth A2 or darker, randomly allocated to two groups. Bleaching trays containing 4% HP were used for three-weeks. A four-week regimen was also offered to the patients for the 30-min group after the end of the 3-week protocol. The color change was assessed with the Vita Classical (VITA Zahnfabrik, Bad Säckingen, Germany) and Vita Bleachedguide shade guides (VITA Zahnfabrik) and the Vita Easyshade spectrophotometer (VITA Zahnfabrik) at baseline, weekly, and 30 days after the bleaching. The absolute risk and the intensity of TS were assessed daily using the 0-10 visual analogue scale (VAS) and 5-point Numerical Rating Scale (NRS) scale, and patient satisfaction was recorded with a Likert 0-7 scale. Risk of TS (Fisher’s test), intensity of TS in NRS scale (Mann-Whitney test), VAS scale (t-test), and a color change (t-test) were compared. Results: The 30-minute group saw color change of around 1 SGU inferior to the 120-minute group in all-time assessments (p&lt;0.05). After an extra week of bleaching, mean color change was similar (p&gt;0.05). Patient satisfaction was high for both groups (p&gt;0.05). Conclusions: A four-week protocol of at-home dental bleaching with 4% HP for 30 minutes/day whitened teeth similarly to the 120 minutes/day protocol, with low intensity of dental sensitivity and high patient satisfaction.


2020 ◽  
Author(s):  
Jin-Kyoung Kim ◽  
Ha-Young Youn ◽  
Myoung-Uk Jin ◽  
Jae-Hyun Ahn ◽  
Seung-Eun Bang ◽  
...  

Abstract Background: To clinically evaluate the efficacy and safety of a primer that contains taurine and self-bleaching patches containing 3.0% hydrogen peroxide.Methods: Overall, 55 participants were selected in this double-blinded randomized clinical trial between March and May 2019. Bleaching patches containing 3.0% hydrogen peroxide were attached using the primer on the labial surface of the upper six anterior teeth for 30 min once daily. △E* values of color changes were measured using Shade Eye NCC for determining the efficacy of bleaching on days 3, 5, 7, and 10 before and after attachment. The safety was assessed using gingival index and visual analog scale for tooth sensitivity and gingival irritation, respectively.Results: △E* values were visibly detected from day 7 after the attachment of patches, and the bleaching effect was identifiable. No statistically significant difference was observed in the gingival index (p = 0.069), tooth sensitivity (p = 0.983), and gingival irritation (p = 0.518).Conclusions: When the self-bleaching patches using 3.0% hydrogen peroxide with the primers were attached for 30 min once daily, visible bleaching effect was observed from day 7 of attachment, and it was verified to be safe for use without any significant adverse effect.Clinical Relevance: This study was conducted after securing safety for clinical trials.Trial registration: ISRCTN63650330


2019 ◽  
Vol 44 (1) ◽  
pp. 13-23 ◽  
Author(s):  
D Cordeiro ◽  
C Toda ◽  
S Hanan ◽  
LP Arnhold ◽  
A Reis ◽  
...  

SUMMARY Objectives: This study aimed to compare the tooth sensitivity, gingival irritation, and bleaching efficacy of at-home whitening performed with 10% hydrogen peroxide (HP) using a conventional tray-delivered system or two different bleaching systems (strips or prefilled disposable trays). Methods and Materials: Sixty patients, with maxillary incisors darker than A2 were selected for this single-blind, parallel randomized clinical trial. Teeth were bleached during 14 days with a 30-minute gel contact with teeth per day. The 10% HP was delivered in a bleaching tray (White Class, FGM) in strips (White Strips, Oral-B) or prefilled disposable trays (Opalescence Go, Ultradent). The color changes were evaluated by subjective (Vita Classical and Vita Bleachedguide) and objective (Easyshade Spectrophotometer) methods at baseline and 30 days after the second bleaching session. Tooth sensitivity was recorded during 14 days with a five-point numeric rating scale (NRS) and 0-10 visual analog scale (VAS). The risk of gingival irritation was also recorded during 14 days on a dichotomous scale. All data were submitted to appropriate statistical analysis (α=0.05). Results: No significant difference was observed in the risks of tooth sensitivity among groups (p&gt;0.09). However, the conventional bleaching tray produced a higher intensity of tooth sensitivity when compared with the strips and prefilled disposable tray systems (p&lt;0.04). Regarding gingival irritation, the prefilled disposable tray system showed a lower risk of gingival irritation when compared with the conventional bleaching tray (p=0.003). Significant whitening was observed in all groups after 30 days of clinical evaluation with no significant difference between them (p&gt;0.06). Conclusions: All 10% HP bleaching systems showed similar whitening after a 14-day use. However, the strips and prefilled disposable trays produced lower intensity of tooth sensitivity than the conventional bleaching tray system. The prefilled disposable tray produced lower risk of gingival irritation when compared to the conventional bleaching tray.


1997 ◽  
Vol 170 (4) ◽  
pp. 381-386 ◽  
Author(s):  
Edgar Jones ◽  
J. P. Watson

BackgroundThe study sought to investigate the form of the delusion in schizophrenia and the overvalued idea in anorexia, employing a range of belief characteristics to discover whether differences could be detected between them, and how they stood in general relationship to the religious beliefs of normals.MethodA belief rating scale was devised with 12 characteristics, and completed by 20 schizophrenics, 20 anorectics, and 20 normal controls. Comparisons were drawn between populations using the Mann-Whitney test, and different types of belief were contrasted within diagnostic groups using each subject as their own control by repeated-measures MANOVA.ResultsThe schizophrenic delusion was differentiated from the overvalued idea in anorexia by a number of variables, which also served to distinguish both phenomena from religious beliefs held by normals. The schizophrenic delusion exhibited many of the qualities of an initial (or observational) belief, when its content suggested that it should manifest those of a derived belief. The anorectic overvalued idea, although occasionally an initial belief in terms of its content, was typically held in the form of a derived belief.ConclusionsA wider range of characteristics is required to define all the differences between delusion and the overvalued idea, and these have implications for belief modification programmes.


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