Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial
IntroductionIn-office tooth whitening treatment using violet light emited diode (LED) (405 nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H2O2). This study describes a protocol for the first randomised c...
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| creator | Santos, Ana Eliza Castanho Garrini dos Bussadori, Sandra Kalil Pinto, Marcelo Mendes Pantano Junior, Dácio Antonio Brugnera Jr, Aldo Zanin, Fátima Antonia Aparecida Rodrigues, Maria Fernanda Setúbal Destro Motta, Lara Jansiski Horliana, Anna Carolina Ratto Tempestini |
| description | IntroductionIn-office tooth whitening treatment using violet light emited diode (LED) (405 nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H2O2). This study describes a protocol for the first randomised controlled clinical trial to compare the effects of the two methods.Methods and analysisEighty patients will be divided into four groups: G1 violet LED; G2 violet LED +35% carbamide peroxide; G3 35% H2O2 and G4 violet LED +gingivoplasty. Colour will be measured at baseline, immediately after the first session and at the 15 and 180 days follow-up using the Vita Classical and the digital Easyshade V spectrophotometer (Vita, Zahnfabrik, Germany). Sensitivity after whitening will be measured using the Visual Analogue Scale at baseline and at each session in all groups and in all follow-ups. The tissue removed during gingivoplasty (G4) will be submitted to immunohistochemical analysis for the determination of inflammatory changes caused by violet LED. The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) will be evaluated before, as well as at established time point controls. The results will be expressed as mean and SD values. After determining the normality of the data, a one-way repeated-measures analysis of variance will be used for the comparison of data with normal distribution and the Kruskal-Wallis test will be used for data with non-normal distribution. A p |
| doi_str_mv | 10.1136/bmjopen-2017-021414 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6129043</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2099894574</sourcerecordid><originalsourceid>FETCH-LOGICAL-b472t-4c87cecf96ae6436d043e00262a91775c6ee24cf0ec03331c4b33f2cb625171f3</originalsourceid><addsrcrecordid>eNqNkU9vEzEQxVcIRKvST4CELHHhssX_d5cDEiqhRYrEBc6W1xk3jrye4HVS9dvjkFAVTvjikeY3b-bpNc1rRq8YE_r9OG1wC6nllHUt5Uwy-aw551TKVlOlnj-pz5rLed7Q-qQalOIvmzNBWc9Yr86b_WJv486WgImgJyG16H1wQApiWZP7dSiQQrojJYMtE6RC7kNt7ANGKGS5-PyBbDMWdBiJx0wsyTatcAozrIjDVDLGeChjSMHZWIWCja-aF97GGS5P_0Xz48vi-_Vtu_x28_X607IdZcdLK13fOXB-0Ba0FHpFpQBKueZ2YF2nnAbg0nkKjgohmJOjEJ67UXPFOubFRfPxqLvdjROsXL0_22i2OUw2Pxi0wfzdSWFt7nBvNONDXVYF3p0EMv7cwVxMdeYgRpsAd7PhdBj6QapOVvTtP-gGdzlVe78prrTUfaXEkXIZ5zmDfzyGUXOI1pyiNYdozTHaOvXmqY_HmT9BVuDqCNTp_1L8BcwKsZg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2099256468</pqid></control><display><type>article</type><title>Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial</title><source>BMJ Open Access Journals</source><source>DOAJ Directory of Open Access Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><source>PubMed Central Open Access</source><creator>Santos, Ana Eliza Castanho Garrini dos ; Bussadori, Sandra Kalil ; Pinto, Marcelo Mendes ; Pantano Junior, Dácio Antonio ; Brugnera Jr, Aldo ; Zanin, Fátima Antonia Aparecida ; Rodrigues, Maria Fernanda Setúbal Destro ; Motta, Lara Jansiski ; Horliana, Anna Carolina Ratto Tempestini</creator><creatorcontrib>Santos, Ana Eliza Castanho Garrini dos ; Bussadori, Sandra Kalil ; Pinto, Marcelo Mendes ; Pantano Junior, Dácio Antonio ; Brugnera Jr, Aldo ; Zanin, Fátima Antonia Aparecida ; Rodrigues, Maria Fernanda Setúbal Destro ; Motta, Lara Jansiski ; Horliana, Anna Carolina Ratto Tempestini</creatorcontrib><description>IntroductionIn-office tooth whitening treatment using violet light emited diode (LED) (405 nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H2O2). This study describes a protocol for the first randomised controlled clinical trial to compare the effects of the two methods.Methods and analysisEighty patients will be divided into four groups: G1 violet LED; G2 violet LED +35% carbamide peroxide; G3 35% H2O2 and G4 violet LED +gingivoplasty. Colour will be measured at baseline, immediately after the first session and at the 15 and 180 days follow-up using the Vita Classical and the digital Easyshade V spectrophotometer (Vita, Zahnfabrik, Germany). Sensitivity after whitening will be measured using the Visual Analogue Scale at baseline and at each session in all groups and in all follow-ups. The tissue removed during gingivoplasty (G4) will be submitted to immunohistochemical analysis for the determination of inflammatory changes caused by violet LED. The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) will be evaluated before, as well as at established time point controls. The results will be expressed as mean and SD values. After determining the normality of the data, a one-way repeated-measures analysis of variance will be used for the comparison of data with normal distribution and the Kruskal-Wallis test will be used for data with non-normal distribution. A p<0.05 will be considered indicative of statistical significance. After determining the normality of the data, the Kruskal-Wallis test will be used for non-parametric data. Multivariate analysis of variance (MANOVA) and the Wilcoxon test will be used for comparing data from the PIDAQ.Ethics and disseminationThis protocol has been approved by the Human Research Ethics Committee of UniversidadeNove de Julho (certificate: 2.034.518). The findings will be published in a peer-reviewed journal.Trial registration number NCT03192852; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2017-021414</identifier><identifier>PMID: 30181185</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Aesthetics ; Clinical trials ; Color ; Dentin ; Dentistry ; Dentistry and Oral Medicine ; Evidence-based medicine ; Light ; Researchers ; Systematic review</subject><ispartof>BMJ open, 2018-09, Vol.8 (9), p.e021414-e021414</ispartof><rights>Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2018 Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-4c87cecf96ae6436d043e00262a91775c6ee24cf0ec03331c4b33f2cb625171f3</citedby><cites>FETCH-LOGICAL-b472t-4c87cecf96ae6436d043e00262a91775c6ee24cf0ec03331c4b33f2cb625171f3</cites><orcidid>0000-0002-7774-4345 ; 0000-0003-3476-9064</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/8/9/e021414.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/8/9/e021414.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27526,27527,27901,27902,53766,53768,77344,77375</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30181185$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Santos, Ana Eliza Castanho Garrini dos</creatorcontrib><creatorcontrib>Bussadori, Sandra Kalil</creatorcontrib><creatorcontrib>Pinto, Marcelo Mendes</creatorcontrib><creatorcontrib>Pantano Junior, Dácio Antonio</creatorcontrib><creatorcontrib>Brugnera Jr, Aldo</creatorcontrib><creatorcontrib>Zanin, Fátima Antonia Aparecida</creatorcontrib><creatorcontrib>Rodrigues, Maria Fernanda Setúbal Destro</creatorcontrib><creatorcontrib>Motta, Lara Jansiski</creatorcontrib><creatorcontrib>Horliana, Anna Carolina Ratto Tempestini</creatorcontrib><title>Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionIn-office tooth whitening treatment using violet light emited diode (LED) (405 nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H2O2). This study describes a protocol for the first randomised controlled clinical trial to compare the effects of the two methods.Methods and analysisEighty patients will be divided into four groups: G1 violet LED; G2 violet LED +35% carbamide peroxide; G3 35% H2O2 and G4 violet LED +gingivoplasty. Colour will be measured at baseline, immediately after the first session and at the 15 and 180 days follow-up using the Vita Classical and the digital Easyshade V spectrophotometer (Vita, Zahnfabrik, Germany). Sensitivity after whitening will be measured using the Visual Analogue Scale at baseline and at each session in all groups and in all follow-ups. The tissue removed during gingivoplasty (G4) will be submitted to immunohistochemical analysis for the determination of inflammatory changes caused by violet LED. The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) will be evaluated before, as well as at established time point controls. The results will be expressed as mean and SD values. After determining the normality of the data, a one-way repeated-measures analysis of variance will be used for the comparison of data with normal distribution and the Kruskal-Wallis test will be used for data with non-normal distribution. A p<0.05 will be considered indicative of statistical significance. After determining the normality of the data, the Kruskal-Wallis test will be used for non-parametric data. Multivariate analysis of variance (MANOVA) and the Wilcoxon test will be used for comparing data from the PIDAQ.Ethics and disseminationThis protocol has been approved by the Human Research Ethics Committee of UniversidadeNove de Julho (certificate: 2.034.518). The findings will be published in a peer-reviewed journal.Trial registration number NCT03192852; Pre-results.</description><subject>Aesthetics</subject><subject>Clinical trials</subject><subject>Color</subject><subject>Dentin</subject><subject>Dentistry</subject><subject>Dentistry and Oral Medicine</subject><subject>Evidence-based medicine</subject><subject>Light</subject><subject>Researchers</subject><subject>Systematic review</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkU9vEzEQxVcIRKvST4CELHHhssX_d5cDEiqhRYrEBc6W1xk3jrye4HVS9dvjkFAVTvjikeY3b-bpNc1rRq8YE_r9OG1wC6nllHUt5Uwy-aw551TKVlOlnj-pz5rLed7Q-qQalOIvmzNBWc9Yr86b_WJv486WgImgJyG16H1wQApiWZP7dSiQQrojJYMtE6RC7kNt7ANGKGS5-PyBbDMWdBiJx0wsyTatcAozrIjDVDLGeChjSMHZWIWCja-aF97GGS5P_0Xz48vi-_Vtu_x28_X607IdZcdLK13fOXB-0Ba0FHpFpQBKueZ2YF2nnAbg0nkKjgohmJOjEJ67UXPFOubFRfPxqLvdjROsXL0_22i2OUw2Pxi0wfzdSWFt7nBvNONDXVYF3p0EMv7cwVxMdeYgRpsAd7PhdBj6QapOVvTtP-gGdzlVe78prrTUfaXEkXIZ5zmDfzyGUXOI1pyiNYdozTHaOvXmqY_HmT9BVuDqCNTp_1L8BcwKsZg</recordid><startdate>20180901</startdate><enddate>20180901</enddate><creator>Santos, Ana Eliza Castanho Garrini dos</creator><creator>Bussadori, Sandra Kalil</creator><creator>Pinto, Marcelo Mendes</creator><creator>Pantano Junior, Dácio Antonio</creator><creator>Brugnera Jr, Aldo</creator><creator>Zanin, Fátima Antonia Aparecida</creator><creator>Rodrigues, Maria Fernanda Setúbal Destro</creator><creator>Motta, Lara Jansiski</creator><creator>Horliana, Anna Carolina Ratto Tempestini</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-7774-4345</orcidid><orcidid>https://orcid.org/0000-0003-3476-9064</orcidid></search><sort><creationdate>20180901</creationdate><title>Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial</title><author>Santos, Ana Eliza Castanho Garrini dos ; Bussadori, Sandra Kalil ; Pinto, Marcelo Mendes ; Pantano Junior, Dácio Antonio ; Brugnera Jr, Aldo ; Zanin, Fátima Antonia Aparecida ; Rodrigues, Maria Fernanda Setúbal Destro ; Motta, Lara Jansiski ; Horliana, Anna Carolina Ratto Tempestini</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-4c87cecf96ae6436d043e00262a91775c6ee24cf0ec03331c4b33f2cb625171f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aesthetics</topic><topic>Clinical trials</topic><topic>Color</topic><topic>Dentin</topic><topic>Dentistry</topic><topic>Dentistry and Oral Medicine</topic><topic>Evidence-based medicine</topic><topic>Light</topic><topic>Researchers</topic><topic>Systematic review</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Santos, Ana Eliza Castanho Garrini dos</creatorcontrib><creatorcontrib>Bussadori, Sandra Kalil</creatorcontrib><creatorcontrib>Pinto, Marcelo Mendes</creatorcontrib><creatorcontrib>Pantano Junior, Dácio Antonio</creatorcontrib><creatorcontrib>Brugnera Jr, Aldo</creatorcontrib><creatorcontrib>Zanin, Fátima Antonia Aparecida</creatorcontrib><creatorcontrib>Rodrigues, Maria Fernanda Setúbal Destro</creatorcontrib><creatorcontrib>Motta, Lara Jansiski</creatorcontrib><creatorcontrib>Horliana, Anna Carolina Ratto Tempestini</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Santos, Ana Eliza Castanho Garrini dos</au><au>Bussadori, Sandra Kalil</au><au>Pinto, Marcelo Mendes</au><au>Pantano Junior, Dácio Antonio</au><au>Brugnera Jr, Aldo</au><au>Zanin, Fátima Antonia Aparecida</au><au>Rodrigues, Maria Fernanda Setúbal Destro</au><au>Motta, Lara Jansiski</au><au>Horliana, Anna Carolina Ratto Tempestini</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2018-09-01</date><risdate>2018</risdate><volume>8</volume><issue>9</issue><spage>e021414</spage><epage>e021414</epage><pages>e021414-e021414</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionIn-office tooth whitening treatment using violet light emited diode (LED) (405 nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H2O2). This study describes a protocol for the first randomised controlled clinical trial to compare the effects of the two methods.Methods and analysisEighty patients will be divided into four groups: G1 violet LED; G2 violet LED +35% carbamide peroxide; G3 35% H2O2 and G4 violet LED +gingivoplasty. Colour will be measured at baseline, immediately after the first session and at the 15 and 180 days follow-up using the Vita Classical and the digital Easyshade V spectrophotometer (Vita, Zahnfabrik, Germany). Sensitivity after whitening will be measured using the Visual Analogue Scale at baseline and at each session in all groups and in all follow-ups. The tissue removed during gingivoplasty (G4) will be submitted to immunohistochemical analysis for the determination of inflammatory changes caused by violet LED. The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) will be evaluated before, as well as at established time point controls. The results will be expressed as mean and SD values. After determining the normality of the data, a one-way repeated-measures analysis of variance will be used for the comparison of data with normal distribution and the Kruskal-Wallis test will be used for data with non-normal distribution. A p<0.05 will be considered indicative of statistical significance. After determining the normality of the data, the Kruskal-Wallis test will be used for non-parametric data. Multivariate analysis of variance (MANOVA) and the Wilcoxon test will be used for comparing data from the PIDAQ.Ethics and disseminationThis protocol has been approved by the Human Research Ethics Committee of UniversidadeNove de Julho (certificate: 2.034.518). The findings will be published in a peer-reviewed journal.Trial registration number NCT03192852; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30181185</pmid><doi>10.1136/bmjopen-2017-021414</doi><orcidid>https://orcid.org/0000-0002-7774-4345</orcidid><orcidid>https://orcid.org/0000-0003-3476-9064</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Aesthetics Clinical trials Color Dentin Dentistry Dentistry and Oral Medicine Evidence-based medicine Light Researchers Systematic review |
| title | Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial |
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