The Open Dentistry Journal




ISSN: 1874-2106 ― Volume 13, 2019
CLINICAL TRIAL STUDY

Evaluation of In-office Vital Tooth Whitening Combined with Different Concentrations of At-home Peroxides: A Randomized Double-blind Clinical Trial



Leandro Féliz-Matos1, *, Ninoska Abreu-Placeres1, Luis Miguel Hernandez1, Carlos Ruiz-Matuk2, Patricia Grau-Grullón1
1 Biomaterials and Dentistry Research Center, Academic Research Department, Universidad Iberoamericana, Santo Domingo, Dominican Republic
2 Department of Statistics - Universidad Iberoamericana (UNIBE), Santo Domingo, Dominican Republic

Abstract

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.

Keywords: Hydrogen peroxide, Carbamide peroxide, Tooth whitening, Dental sensitivity, Tooth bleaching, Dental Esthetics.


Article Information


Identifiers and Pagination:

Year: 2019
Volume: 13
First Page: 377
Last Page: 382
Publisher Id: TODENTJ-13-377
DOI: 10.2174/1874210601913010377

Article History:

Received Date: 22/05/2019
Revision Received Date: 30/08/2019
Acceptance Date: 13/10/2019
Electronic publication date: 15/11/2019
Collection year: 2019

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© 2019 Feliz-Matos et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


* Address correspondence to this author at the Biomaterials and Dentistry Research Center (CIBO-UNIBE), Academic Research Department, Universidad Iberoamericana, Avenida Francia #129 - Gascue, Santo Domingo, Dominican Republic Tel: (809) 689-4111 Ext. 1501; Fax: (809) 731-2904;
Email: l.feliz@unibe.edu.do






1. INTRODUCTION

Vital Tooth Whitening (VTW) is a widely documented non-invasive technique that improves the aesthetic for discolo-red teeth [1Torres CR, Crastechini E, Feitosa FA, Pucci CR, Borges AB. Influence of pH on the effectiveness of hydrogen peroxide whitening. Oper Dent 2014; 39(6): E261-8.
[http://dx.doi.org/10.2341/13-214-L] [PMID: 25136903]
-10Kose C, Calixto AL, Bauer JR, Reis A, Loguercio AD. Comparison of the effects of in-office bleaching times on whitening and tooth sensitivity: A single blind, randomized clinical trial. Oper Dent 2016; 41(2): 138-45.
[http://dx.doi.org/10.2341/15-085-C] [PMID: 26509229]
]. At - home VTW with custom or prefill trays is usually done daily for several hours per week with low concentrations (10% to 20% resulting in 3.35 - 7% hydrogen peroxide) of Carbamide Peroxide (CP) [11Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients’ acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent 2005; 30(2): 156-63.
[PMID: 15853099]
-13Féliz-Matos L, Hernández LM, Abreu N. Dental bleaching techniques; hydrogen-carbamide peroxides and light sources for activation, an update. Mini review article. Open Dent J 2015; 8: 264-8.
[http://dx.doi.org/10.2174/1874210601408010264] [PMID: 25646134]
]. The 10% CP is considered as the “gold standard” for VTW, since it presents great results with lower risk and intensity of Dental Sensitivity (DS) for the patients [3Basting RT, Amaral FL, França FM, Flório FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent 2012; 37(5): 464-73.
[http://dx.doi.org/10.2341/11-337-C] [PMID: 22616927]
, 7da Costa JB, McPharlin R, Paravina RD, Ferracane JL. Comparison of at-home and in-office tooth whitening using a novel shade guide. Oper Dent 2010; 35(4): 381-8.
[http://dx.doi.org/10.2341/09-344-C] [PMID: 20672721]
, 13Féliz-Matos L, Hernández LM, Abreu N. Dental bleaching techniques; hydrogen-carbamide peroxides and light sources for activation, an update. Mini review article. Open Dent J 2015; 8: 264-8.
[http://dx.doi.org/10.2174/1874210601408010264] [PMID: 25646134]
-17Carlos NR, Bridi EC, Amaral F, França F, Turssi CP, Basting RT. Efficacy of home-use bleaching agents delivered in customized or prefilled disposable trays: A randomized clinical trial. Oper Dent 2017; 42(1): 30-40.
[http://dx.doi.org/10.2341/15-315-C] [PMID: 27723425]
]. Despite its advantages, some patients request quicker results, therefore in-office, VTW using higher concentrations (20 -40%) of Hydrogen Peroxide (HP) is an alternative [18Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent 2011; 36(6): 590-6.
[http://dx.doi.org/10.2341/10-173-C] [PMID: 21913864]
-20de Geus JL, Wambier LM, Kossatz S, Loguercio AD, Reis A. At-home vs in-office bleaching: A systematic review and meta-analysis. Oper Dent 2016; 41(4): 341-56.
[http://dx.doi.org/10.2341/15-287-LIT] [PMID: 27045285]
]. Both techniques have shown favorable effectiveness in color changes [1Torres CR, Crastechini E, Feitosa FA, Pucci CR, Borges AB. Influence of pH on the effectiveness of hydrogen peroxide whitening. Oper Dent 2014; 39(6): E261-8.
[http://dx.doi.org/10.2341/13-214-L] [PMID: 25136903]
, 3Basting RT, Amaral FL, França FM, Flório FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent 2012; 37(5): 464-73.
[http://dx.doi.org/10.2341/11-337-C] [PMID: 22616927]
, 5Tay LY, Kose C, Herrera DR, Reis A, Loguercio AD. Long-term efficacy of in-office and at-home bleaching: A 2-year double-blind randomized clinical trial. Am J Dent 2012; 25(4): 199-204.
[PMID: 23082382]
, 9Giachetti L, Bertini F, Bambi C, Nieri M, Scaminaci Russo D. A randomized clinical trial comparing at-home and in-office tooth whitening techniques: A nine-month follow-up. J Am Dent Assoc 2010; 141(11): 1357-64.
[http://dx.doi.org/10.14219/jada.archive.2010.0081] [PMID: 21037194]
, 11Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients’ acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent 2005; 30(2): 156-63.
[PMID: 15853099]
, 13Féliz-Matos L, Hernández LM, Abreu N. Dental bleaching techniques; hydrogen-carbamide peroxides and light sources for activation, an update. Mini review article. Open Dent J 2015; 8: 264-8.
[http://dx.doi.org/10.2174/1874210601408010264] [PMID: 25646134]
, 14Bernardon JK, Ferrari P, Baratieri LN, Rauber GB. Comparison of treatment time versus patient satisfaction in at-home and in-office tooth bleaching therapy. J Prosthet Dent 2015; 114(6): 826-30.
[http://dx.doi.org/10.1016/j.prosdent.2015.05.014] [PMID: 26372629]
, 19Vaez SC, Correia A, Santana TR, et al. Is a single preliminary session of in-office bleaching beneficial for the effectiveness of at-home tooth bleaching? A randomized controlled clinical trial. Oper Dent 2019; 44(4): E180-9.
[http://dx.doi.org/10.2341/18-196-C] [PMID: 30849011]
-23Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined bleaching technique using low and high hydrogen peroxide in-office bleaching gel. Oper Dent 2016; 41(4): 388-96.
[http://dx.doi.org/10.2341/15-266-C] [PMID: 26919081]
].

In order to overcome the drawbacks of each procedure, the combination of both methods has been widely accepted, resulting in achieving fast effects with less gingiva irritation and DS [8Deliperi S, Bardwell DN, Papathanasiou A. Clinical evaluation of a combined in-office and take-home bleaching system. J Am Dent Assoc 2004; 135(5): 628-34.
[http://dx.doi.org/10.14219/jada.archive.2004.0252] [PMID: 15202756]
, 12Martos J, Kinalski MA. Combined in-office and take-home bleaching in vital teeth. J Restorat Dent 2014; 2(3): 149.
[http://dx.doi.org/10.4103/2321-4619.143599]
, 22Machado LS, Anchieta RB, dos Santos PH, et al. Clinical comparison of at-home and in-office dental bleaching procedures: A randomized trial of a split-mouth design. Int J Periodontics Restorative Dent 2016; 36(2): 251-60.
[http://dx.doi.org/10.11607/prd.2383] [PMID: 26901303]
, 24Dawson PF, Sharif MO, Smith AB, Brunton PA. A clinical study comparing the efficacy and sensitivity of home vs combined whitening. Oper Dent 2011; 36(5): 460-6.
[http://dx.doi.org/10.2341/10-159-C] [PMID: 21859318]
]. However, Machado et al. [22Machado LS, Anchieta RB, dos Santos PH, et al. Clinical comparison of at-home and in-office dental bleaching procedures: A randomized trial of a split-mouth design. Int J Periodontics Restorative Dent 2016; 36(2): 251-60.
[http://dx.doi.org/10.11607/prd.2383] [PMID: 26901303]
], found that the combined technique produced greater DS and the same whitening results when compared to the at-home technique. Vaez et al. [19Vaez SC, Correia A, Santana TR, et al. Is a single preliminary session of in-office bleaching beneficial for the effectiveness of at-home tooth bleaching? A randomized controlled clinical trial. Oper Dent 2019; 44(4): E180-9.
[http://dx.doi.org/10.2341/18-196-C] [PMID: 30849011]
], concluded that the combined technique reduced the time necessary to obtain satisfactory tooth color compared with at-home bleaching, but increased the risk and level of DS.

Longer contact time and higher peroxide concentrations provide faster result, though a medium to severe intensity of DS has been reported [2Peixoto AC, Vaez SC, Pereira NAR, et al. High-concentration carbamide peroxide can reduce the sensitivity caused by in-office tooth bleaching: A single-blinded randomized controlled trial. J Appl Oral Sci 2018; 26e20170573
[http://dx.doi.org/10.1590/1678-7757-2017-0573] [PMID: 30084472]
, 4Rodrigues JL, Rocha PS, Pardim SLS, Machado ACV, Faria-E-Silva AL, Seraidarian PI. Association between in-office and at-home tooth bleaching: A single blind randomized clinical trial. Braz Dent J 2018; 29(2): 133-9.
[http://dx.doi.org/10.1590/0103-6440201801726] [PMID: 29898058]
, 11Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients’ acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent 2005; 30(2): 156-63.
[PMID: 15853099]
, 21Roderjan DA, Stanislawczuk R, Hebling J, Costa CA, Reis A, Loguercio AD. Response of human pulps to different in-office bleaching techniques: preliminary findings. Braz Dent J 2015; 26(3): 242-8.
[http://dx.doi.org/10.1590/0103-6440201302282] [PMID: 26200147]
, 23Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined bleaching technique using low and high hydrogen peroxide in-office bleaching gel. Oper Dent 2016; 41(4): 388-96.
[http://dx.doi.org/10.2341/15-266-C] [PMID: 26919081]
, 25Coppla FM, Rezende M, de Paula E, et al. Combination of acetaminophen/codeine analgesics does not avoid bleaching-induced tooth sensitivity: A randomized, triple-blind two-center clinical trial. Oper Dent 2018; 43(2): E53-63.
[http://dx.doi.org/10.2341/17-092-C] [PMID: 29504880]
]. To decrease DS in at-office protocols, it has been suggested that a single application of the VTW gel is applied, since the amount of product that reaches the pulp might be reduced, although Reis et al. [18Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent 2011; 36(6): 590-6.
[http://dx.doi.org/10.2341/10-173-C] [PMID: 21913864]
], showed that one 45 minutes application reduces the whitening speed and increases the DS intensity, compared to 3- 15 minutes protocol. In order to decrease the interaction with high Hydrogen Peroxide concentration, Rodriguez et al. [4Rodrigues JL, Rocha PS, Pardim SLS, Machado ACV, Faria-E-Silva AL, Seraidarian PI. Association between in-office and at-home tooth bleaching: A single blind randomized clinical trial. Braz Dent J 2018; 29(2): 133-9.
[http://dx.doi.org/10.1590/0103-6440201801726] [PMID: 29898058]
], evaluated the combined technique with two in-office sessions, showing that both protocols result in acceptable color and same DS, in this order Kose et al. [10Kose C, Calixto AL, Bauer JR, Reis A, Loguercio AD. Comparison of the effects of in-office bleaching times on whitening and tooth sensitivity: A single blind, randomized clinical trial. Oper Dent 2016; 41(2): 138-45.
[http://dx.doi.org/10.2341/15-085-C] [PMID: 26509229]
], found that a single 15 minutes session produced less DS but reduced the whitening effect. Roderjam et al. [21Roderjan DA, Stanislawczuk R, Hebling J, Costa CA, Reis A, Loguercio AD. Response of human pulps to different in-office bleaching techniques: preliminary findings. Braz Dent J 2015; 26(3): 242-8.
[http://dx.doi.org/10.1590/0103-6440201302282] [PMID: 26200147]
], concluded that calcium-containing gel could cause less pulp damage and DS. Obtaining acceptable results in terms of satisfactory color modification with none or minimal DS has been the main objective of clinical researchers, this is why continuing modifications in the VTW protocols is still proposed.

To the best of authors’ knowledge, no clinical study has evaluated the whitening effect of the combined technique with shortened application. Therefore, the purpose of this randomized double-blind clinical trial was to evaluate the effect on color change and DS when decreasing the application time of in-office VTW combined with different concentrations of at-home products.

2. MATERIALS AND METHODS

This clinical trial was approved by UNIBE’s Ethics Committee (CEI) No. CEI2013-07 and The National Committee for Health Bioethics (CONABIOS) No.024-2013 [26CONABIOS: Consejo Nacional de Bioetica. Santo Domingo - República Dominica. Available: . http://conabios.gob.do/reglamento/]. The clinical trials identifier is: NCT02682329 [27U.S. national Library of Medicine: ClinicalTrials.gov. Available: . https://clinicaltrials.gov/ct2/show/NCT02682329]. This report follows the protocol established by CONSORT Statement. The study design was a randomized double-blind clinical trial (Fig. 1).

2.1. Eligibility Criteria

An open call was started to recruit the sample, volunteers requiring vital tooth whitening were selected for this study. The clinical trial was conducted at the school of dentistry of Universidad Iberoamericana (Santo Domingo, Dominican Republic) from September 2013- February 2014.

A total of 120 participants between ages 18 to 45 were recruited at the UNIBE’S dental clinics and after signing the informed consent, a medical and the dental record were completed. After a dental prophylaxis and clinical examination, it was determined if the subject was able to participate in the study according to the exclusion criteria defined: patients with caries, restoration, veneers of full crowns or endodontic treatment, severe stains, enamel hypoplasia, severe internal tooth discoloration, gingival recession, spontaneous tooth pain, previous bleaching procedure, use of orthodontics appliances up to the second premolar of both dental arches. Also, patients with bruxism habits, taking analgesic or anti-inflammatory drugs, smokers, and pregnant or lactating applicants were excluded.

2.2. Randomization

Four groups of treatment were defined, the randomization occurred through a card color system for the codification of the different peroxide concentrations of bleaching syringes and to be able to assign the participant into groups, only the principal Investigator was aware of system details. Details of the composition, mode of application and brands of the whitening products are described in Table 1. The participants were randomly assigned into 4 experimental groups: G1= Carbamide Peroxide 10% (CP10%) + Hydrogen Peroxide 40% (HP40%) G2= Carbamide Peroxide 15% (CP15%) + Hydrogen Peroxide 40% (HP40%), G3= Carbamide Peroxide 20% (CP20%) + Hydrogen Peroxide 40% (HP40%), G4= Hydrogen Peroxide 10% (HP10%) + Hydrogen Peroxide 40% (HP40%) (Table 2).

2.3. Study Intervention

2.3.1. In-office VTW Procedure

All patients included in the study were subjected to an initial in-office VTW with 40% HP (Opalescense Xtra Boost Ultradent, USA) without light activation as recommended by the manufacturer. The VTW procedure was performed up to the second premolar of both dental arches (first molar could be included in case of absence of the second premolars). A light-cure resin dam was applied to the gingival tissue to isolate and protect it. The in-office VTW was applied for 20 minutes single application. The manufacturer's recommendation is 45 minutes application in three consecutive 15-minutes intervals. After finishing the process; the teeth were rinsed with copious water. The in-office VTW was performed in two sessions, with an interval of 8 days between them, during which time home bleaching was done.

2.3.2. At-home VTW Procedure

For groups 1, 2 and 3 alginate impressions (Tropicalgin - Zhermark) of both arches were made. The stone molds were produced to fabricate the whitening trays with reservoirs. The patients were instructed to place a small drop of the gel into each tooth of the tray; then after insertion, the excess of gel must be wiped away from the gingiva with a quick tip. Group 4 used prefabricated trays. The patients were advised to use the in-home VTW daily for 1 hour according to the allocation: group 1 for 7 days; group 2 for 5 days; group 3 and 4 for 2 days.

Table 1
Details of the brand, composition and mode of application according to the manufacturer.


Fig. (1)
Consort flow diagram of the clinical trial.


Analgesic, anti-inflammatory or desensitizing gels were indicated to the patient with moderate and severe tooth sensitivity [4Rodrigues JL, Rocha PS, Pardim SLS, Machado ACV, Faria-E-Silva AL, Seraidarian PI. Association between in-office and at-home tooth bleaching: A single blind randomized clinical trial. Braz Dent J 2018; 29(2): 133-9.
[http://dx.doi.org/10.1590/0103-6440201801726] [PMID: 29898058]
].

2.3.3. Visual Analysis of Color Change

The visual analysis of color change was recorded for each volunteer in four intervals: 1. At baseline, 2. Immediately after in-office session, 3. After the conclusion of at-home treatment and 4. Final color tooth measurement, using a shade guide (Vita Classical, Vita Zahn Fabric) organized by scores from B1 (1) to C4 (16). The middle third of the canines of both dental arcades were analyzed for the degree of color change. Two calibrated examiners performed the evaluations; the final color was determined based on a consensus of both.

2.3.4. Dental Sensitivity Analysis

DS was analyzed after the at-office and at-home VTW treatment. The visual analogue scale method was used, with a scale 0 to 3, with 0 indicating no sensitivity, 1low sensitivity, 2 medium sensitivity and 3 indicating severe sensitivity.

Table 2
Experimental groups.


2.3.5. Statistical Analysis

The data collected from 83 patients was registered. The mean and standard deviation were calculated for each group at each evaluation intervals. The two- way ANOVA and Tukey for pairwise comparison (p<. 05) were used. The means of DS were analyzed using one-way analysis of variance (ANOVA) to evaluate the color change between groups at each interval. The means of dental sensitivity were compared using the One- way ANOVA and Tukey test (p<0.05) for each whitening protocol. All results were analyzed using the SPSS version (23) (SPSS inc, Chicago, IL, USA).

3. RESULTS

A total of 120 patients were included in this clinical study, where 83 completed the whitening protocol and attended recalls appointment, 37 volunteers did not complete the treatment or missed appointments for evaluation.

The baseline tooth color in the superior arch was 4.76 +/-3.53 and 6.89 +/- 2.78 in the inferior arch. The mean color change results for each group are described in Table 3 and 4. Analysis of variance (ANOVA) and HSD Tukey test detected that there was no statistical significance for the color change in the superior/ inferior arc for de 4 experimental groups (p= 0.183/ p=0.374). All in-office combined with different in-home gels were effective for color change for vital tooth whitening (Tables 4-5). No statistically significant differences were found in tooth color change between subjects, p= 0.065 and within subjects, p= 0.187

The final DS mean of each group are described in Table 6. No statistically significant differences were found in dental sensitivity between subjects, p=0.268 (Table 7).

Table 3
Mean values of color change superior arch in each intervention.


4. DISCUSSION

The whitening effect is related to the concentration and application time [10Kose C, Calixto AL, Bauer JR, Reis A, Loguercio AD. Comparison of the effects of in-office bleaching times on whitening and tooth sensitivity: A single blind, randomized clinical trial. Oper Dent 2016; 41(2): 138-45.
[http://dx.doi.org/10.2341/15-085-C] [PMID: 26509229]
, 13Féliz-Matos L, Hernández LM, Abreu N. Dental bleaching techniques; hydrogen-carbamide peroxides and light sources for activation, an update. Mini review article. Open Dent J 2015; 8: 264-8.
[http://dx.doi.org/10.2174/1874210601408010264] [PMID: 25646134]
], all the techniques investigated in this randomized double-blind clinical trial showed significant color change with no statistical differences between the groups, regardless of in-home concentration, from 10 to 20% and application protocol, from 2 to 7 days. This has an important clinical implication: reducing the in-office time to half, from 40 minutes, indicated by the manufacturer, to 20 minutes in two sessions, combined with at-home products for just 2 days (group 4) could be effective in better tooth whitening results.

Table 4
Mean values of color change inferior arch in each intervention.


Table 5
Total mean values of color change inferior arch.


Table 6
Total mean values of color change inferior arch.


Table 7
Mean values of dental sensitivity.


Long chair-time, usually 40 - 45 minutes in two or three different appointments and high risk of TS are most common complains about in-office VTW [2Peixoto AC, Vaez SC, Pereira NAR, et al. High-concentration carbamide peroxide can reduce the sensitivity caused by in-office tooth bleaching: A single-blinded randomized controlled trial. J Appl Oral Sci 2018; 26e20170573
[http://dx.doi.org/10.1590/1678-7757-2017-0573] [PMID: 30084472]
, 10Kose C, Calixto AL, Bauer JR, Reis A, Loguercio AD. Comparison of the effects of in-office bleaching times on whitening and tooth sensitivity: A single blind, randomized clinical trial. Oper Dent 2016; 41(2): 138-45.
[http://dx.doi.org/10.2341/15-085-C] [PMID: 26509229]
, 13Féliz-Matos L, Hernández LM, Abreu N. Dental bleaching techniques; hydrogen-carbamide peroxides and light sources for activation, an update. Mini review article. Open Dent J 2015; 8: 264-8.
[http://dx.doi.org/10.2174/1874210601408010264] [PMID: 25646134]
]. The main concern regarding in-home whitening is the longer time required to obtain a satisfactory color. Two combined protocol have been suggested, a whitening treatment in a single 40 minutes in-office session as a jump-start for the initial effect and shortening the time required for at-home procedure [19Vaez SC, Correia A, Santana TR, et al. Is a single preliminary session of in-office bleaching beneficial for the effectiveness of at-home tooth bleaching? A randomized controlled clinical trial. Oper Dent 2019; 44(4): E180-9.
[http://dx.doi.org/10.2341/18-196-C] [PMID: 30849011]
]. Rodriguez et al. [4Rodrigues JL, Rocha PS, Pardim SLS, Machado ACV, Faria-E-Silva AL, Seraidarian PI. Association between in-office and at-home tooth bleaching: A single blind randomized clinical trial. Braz Dent J 2018; 29(2): 133-9.
[http://dx.doi.org/10.1590/0103-6440201801726] [PMID: 29898058]
], concluded that the combined protocol using a tray for 1week after the in-office VTW could increase the TS when compared to two in-office sessions.

In this study, group 4 used in-home HP 10% bleaching with a prefabricated tray for just 2 days reporting the same results compared with the other combinations evaluated. This also has a significant clinical inference: favors the clinician’s preference to simplification: This product requires no impression, plaster cats or costume made tray, reducing the treatment time. Carlos et al. [17Carlos NR, Bridi EC, Amaral F, França F, Turssi CP, Basting RT. Efficacy of home-use bleaching agents delivered in customized or prefilled disposable trays: A randomized clinical trial. Oper Dent 2017; 42(1): 30-40.
[http://dx.doi.org/10.2341/15-315-C] [PMID: 27723425]
], found no significant differences among the acceptance of prefill and custom-made trays. Also, aggressive bleaching protocols can cause pulp damage resulting in a rebound effect of the bleached teeth due to the production of reactional dentin [4Rodrigues JL, Rocha PS, Pardim SLS, Machado ACV, Faria-E-Silva AL, Seraidarian PI. Association between in-office and at-home tooth bleaching: A single blind randomized clinical trial. Braz Dent J 2018; 29(2): 133-9.
[http://dx.doi.org/10.1590/0103-6440201801726] [PMID: 29898058]
].

The DS, a common side effect of whitening treatments, is the principal concern related to this procedure reported by patients, especially in-office treatments [2Peixoto AC, Vaez SC, Pereira NAR, et al. High-concentration carbamide peroxide can reduce the sensitivity caused by in-office tooth bleaching: A single-blinded randomized controlled trial. J Appl Oral Sci 2018; 26e20170573
[http://dx.doi.org/10.1590/1678-7757-2017-0573] [PMID: 30084472]
, 16Bernardon JK, Vieira Martins M, Branco Rauber G, Monteiro Junior S, Baratieri LN. Clinical evaluation of different desensitizing agents in home-bleaching gels. J Prosthet Dent 2016; 115(6): 692-6.
[http://dx.doi.org/10.1016/j.prosdent.2015.10.020] [PMID: 26794704]
, 28Correa AC, Santana TR, Nahsan FP, Loguercio AD, Faria-E-Silva AL. The impact of a customized tray on in-office bleaching tooth sensitivity: A randomized clinical trial. Oper Dent 2016; 41(1): 15-22.
[http://dx.doi.org/10.2341/15-029-C] [PMID: 26244263]
]. The hydrogen peroxide has a rapid diffusion into enamel prism due to its low molecular mass reaching the pulp chamber through the dentinal tubules. Although the majority of people are able to tolerate tooth whitening, sensitivity is a major problem. In this study, there was no statistical difference in sensitivity between the groups (p=0.268). Basting et al. [3Basting RT, Amaral FL, França FM, Flório FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent 2012; 37(5): 464-73.
[http://dx.doi.org/10.2341/11-337-C] [PMID: 22616927]
], found that 13.8% participants experienced extreme sensitivity that forces them to quit the study, also Briso et al. [15Briso ALF, Rahal V, Azevedo FA, et al. Neurosensory analysis of tooth sensitivity during at-home dental bleaching: A randomized clinical trial. J Appl Oral Sci 2018; 26e20170284
[http://dx.doi.org/10.1590/1678-7757-2017-0284] [PMID: 29742258]
], reported spontaneous low to moderate TS during all treatment periods, equal to the findings in this study.

Vaez et al. [19Vaez SC, Correia A, Santana TR, et al. Is a single preliminary session of in-office bleaching beneficial for the effectiveness of at-home tooth bleaching? A randomized controlled clinical trial. Oper Dent 2019; 44(4): E180-9.
[http://dx.doi.org/10.2341/18-196-C] [PMID: 30849011]
], found a greater risk of DS with the combined protocol compared with in-home techniques with 10% carbamide peroxide. Kose et al. [10Kose C, Calixto AL, Bauer JR, Reis A, Loguercio AD. Comparison of the effects of in-office bleaching times on whitening and tooth sensitivity: A single blind, randomized clinical trial. Oper Dent 2016; 41(2): 138-45.
[http://dx.doi.org/10.2341/15-085-C] [PMID: 26509229]
], suggested that a multiple appointment with a single 15 minutes applications can reduce the pulp tissue damage with satisfactory results. Moghadam et al. [29Moghadam FV, Majidinia S, Chasteen J, Ghavamnasiri M. The degree of color change, rebound effect and sensitivity of bleached teeth associated with at-home and power bleaching techniques: A randomized clinical trial. Eur J Dent 2013; 7(4): 405-11.
[http://dx.doi.org/10.4103/1305-7456.120655] [PMID: 24932113]
], founded no differences in TS between in-office and in-home VTW techniques. Patients with darker teeth and those who used in-home VTW presented lower intensity and risk TS [23Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined bleaching technique using low and high hydrogen peroxide in-office bleaching gel. Oper Dent 2016; 41(4): 388-96.
[http://dx.doi.org/10.2341/15-266-C] [PMID: 26919081]
].

The method used to assess the color change in this study was the Vital Classical shade scale, as other clinical trials [3Basting RT, Amaral FL, França FM, Flório FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent 2012; 37(5): 464-73.
[http://dx.doi.org/10.2341/11-337-C] [PMID: 22616927]
, 11Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients’ acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent 2005; 30(2): 156-63.
[PMID: 15853099]
, 18Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent 2011; 36(6): 590-6.
[http://dx.doi.org/10.2341/10-173-C] [PMID: 21913864]
, 22Machado LS, Anchieta RB, dos Santos PH, et al. Clinical comparison of at-home and in-office dental bleaching procedures: A randomized trial of a split-mouth design. Int J Periodontics Restorative Dent 2016; 36(2): 251-60.
[http://dx.doi.org/10.11607/prd.2383] [PMID: 26901303]
, 28Correa AC, Santana TR, Nahsan FP, Loguercio AD, Faria-E-Silva AL. The impact of a customized tray on in-office bleaching tooth sensitivity: A randomized clinical trial. Oper Dent 2016; 41(1): 15-22.
[http://dx.doi.org/10.2341/15-029-C] [PMID: 26244263]
] frequently used to show the beginning and final color to the patient in dental office [17Carlos NR, Bridi EC, Amaral F, França F, Turssi CP, Basting RT. Efficacy of home-use bleaching agents delivered in customized or prefilled disposable trays: A randomized clinical trial. Oper Dent 2017; 42(1): 30-40.
[http://dx.doi.org/10.2341/15-315-C] [PMID: 27723425]
]. Two trained examiners measured the color after each session protocol was blinded to the experimental conditions. Despite the subjectivity of visual assessment, this method is easy, fast, and satisfactory with good reliability [18Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent 2011; 36(6): 590-6.
[http://dx.doi.org/10.2341/10-173-C] [PMID: 21913864]
, 22Machado LS, Anchieta RB, dos Santos PH, et al. Clinical comparison of at-home and in-office dental bleaching procedures: A randomized trial of a split-mouth design. Int J Periodontics Restorative Dent 2016; 36(2): 251-60.
[http://dx.doi.org/10.11607/prd.2383] [PMID: 26901303]
].

In recent studies, the impact on the quality of life and the patient’s level of satisfaction related to the color of their teeth before and after the bleaching treatment has been considered [9Giachetti L, Bertini F, Bambi C, Nieri M, Scaminaci Russo D. A randomized clinical trial comparing at-home and in-office tooth whitening techniques: A nine-month follow-up. J Am Dent Assoc 2010; 141(11): 1357-64.
[http://dx.doi.org/10.14219/jada.archive.2010.0081] [PMID: 21037194]
, 11Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients’ acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent 2005; 30(2): 156-63.
[PMID: 15853099]
, 14Bernardon JK, Ferrari P, Baratieri LN, Rauber GB. Comparison of treatment time versus patient satisfaction in at-home and in-office tooth bleaching therapy. J Prosthet Dent 2015; 114(6): 826-30.
[http://dx.doi.org/10.1016/j.prosdent.2015.05.014] [PMID: 26372629]
, 16Bernardon JK, Vieira Martins M, Branco Rauber G, Monteiro Junior S, Baratieri LN. Clinical evaluation of different desensitizing agents in home-bleaching gels. J Prosthet Dent 2016; 115(6): 692-6.
[http://dx.doi.org/10.1016/j.prosdent.2015.10.020] [PMID: 26794704]
, 19Vaez SC, Correia A, Santana TR, et al. Is a single preliminary session of in-office bleaching beneficial for the effectiveness of at-home tooth bleaching? A randomized controlled clinical trial. Oper Dent 2019; 44(4): E180-9.
[http://dx.doi.org/10.2341/18-196-C] [PMID: 30849011]
]. In the present study, the combination of an initial 20 minutes in-office therapy with different in-home protocol and a final 20 minutes whitening showed that the color change process was gradual, the initial color was between A3 - A3.5 decreasing to a final color between A1 to B1, reducing the number of days and application time, indicating that the participants were satisfied with the results. Rezende et al. [23Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined bleaching technique using low and high hydrogen peroxide in-office bleaching gel. Oper Dent 2016; 41(4): 388-96.
[http://dx.doi.org/10.2341/15-266-C] [PMID: 26919081]
], explained that regardless of the VTW technique used by the clinician, the baseline color showed a significant effect on overall whitening efficacy, especially in younger patients or with darker teeth.

The concentration agent and the bleaching technique are one of the principal factors to be considered in the effectiveness of the whitening procedure. Also Torres et al. [1Torres CR, Crastechini E, Feitosa FA, Pucci CR, Borges AB. Influence of pH on the effectiveness of hydrogen peroxide whitening. Oper Dent 2014; 39(6): E261-8.
[http://dx.doi.org/10.2341/13-214-L] [PMID: 25136903]
], exposed that the efficacy of VTW is directly proportional to the pH, additionally the application time, safety, side effects evolved and patient’s preferences must be taken into consideration [3Basting RT, Amaral FL, França FM, Flório FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent 2012; 37(5): 464-73.
[http://dx.doi.org/10.2341/11-337-C] [PMID: 22616927]
]. The outcomes of this study showed that reducing in half the application time of in-office bleaching combined with at-home products results in positive VTW color changes, however further studies considering the patients' level of satisfaction could increase the evidence. Another limitation of this study was that final color was evaluated immediately after the second VTW application; Correa et al. [28Correa AC, Santana TR, Nahsan FP, Loguercio AD, Faria-E-Silva AL. The impact of a customized tray on in-office bleaching tooth sensitivity: A randomized clinical trial. Oper Dent 2016; 41(1): 15-22.
[http://dx.doi.org/10.2341/15-029-C] [PMID: 26244263]
], suggest longer periods of follow-up to allow color stabilization because teeth appear whiter immediately after the VTW procedure due to dehydration and demineralization caused by the acidity of the agent [4Rodrigues JL, Rocha PS, Pardim SLS, Machado ACV, Faria-E-Silva AL, Seraidarian PI. Association between in-office and at-home tooth bleaching: A single blind randomized clinical trial. Braz Dent J 2018; 29(2): 133-9.
[http://dx.doi.org/10.1590/0103-6440201801726] [PMID: 29898058]
].

CONCLUSION

Within the limitation of this study, it was determined that the reduction in the application time of in-office whitening with different at-home products was effective in color change for VTW, the result was the same for all groups. As for the matter of post-treatment sensitivity, all the VTW combinations were identical.

ETHICS APPROVAL AND CONSENT TO PARTICIPATE

This clinical trial was approved by UNIBE’s Ethics Committee (CEI) No. CEI2013-07 and The National Committee for Health Bioethics (CONABIOS) No.024-2013.

HUMAN AND ANIMAL RIGHTS

No Animals were used in this research. All human research procedures were followed in accordance with the ethical standards of the committee responsible for human experimentation (institutional and national), and with the Helsinki Declaration of 1975, as revised in 2013.

CONSENT FOR PUBLICATION

The participant provided written informed consent.

STANDARDS OF REPORTING

This report follows the protocol established by CONSORT Statement.

AVAILABILITY OF DATA AND MATERIALS

The authors confirm that the data supporting the findings of this study are available within the article.

FUNDING

UNIBE's competitive research fund (FICU). (Grant Code No. 02/2014).

CONFLICT OF INTEREST

The authors declare no conflict of interest, financial or otherwise.

ACKNOWLEDGEMENTS

The authors are thankful to Ultradent USA.

REFERENCES

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