Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial
Introduction In-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...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2018-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/8/9/e021414.full |
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| author | Lara Jansiski Motta Anna Carolina Ratto Tempestini Horliana Sandra Kalil Bussadori Maria Fernanda Setúbal Destro Rodrigues Ana Eliza Castanho Garrini dos Santos Marcelo Mendes Pinto Dácio Antonio Pantano Junior Aldo Brugnera Jr Fátima Antonia Aparecida Zanin |
| author_facet | Lara Jansiski Motta Anna Carolina Ratto Tempestini Horliana Sandra Kalil Bussadori Maria Fernanda Setúbal Destro Rodrigues Ana Eliza Castanho Garrini dos Santos Marcelo Mendes Pinto Dácio Antonio Pantano Junior Aldo Brugnera Jr Fátima Antonia Aparecida Zanin |
| author_sort | Lara Jansiski Motta |
| collection | DOAJ |
| description | Introduction In-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 analysis Eighty 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 dissemination This 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. |
| format | Article |
| id | doaj-art-38c56cfb9ff4477f9b959814a4b0f470 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2018-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-38c56cfb9ff4477f9b959814a4b0f4702025-02-12T01:30:14ZengBMJ Publishing GroupBMJ Open2044-60552018-09-018910.1136/bmjopen-2017-021414Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trialLara Jansiski Motta0Anna Carolina Ratto Tempestini Horliana1Sandra Kalil Bussadori2Maria Fernanda Setúbal Destro Rodrigues3Ana Eliza Castanho Garrini dos Santos4Marcelo Mendes Pinto5Dácio Antonio Pantano Junior6Aldo Brugnera Jr7Fátima Antonia Aparecida Zanin81 Biophotonics Applied to Health Sciences Postgraduate Program, Universidade Nove de Julho (UNINOVE), Sao Paulo, Brazil5 Postgraduate program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho - Campus Vergueiro, Sao Paulo, SP, Brazil1 Postgraduate Program in Biophotonics Appliedto Health Sciences, Nove de Julho University, São Paulo, BrazilPost Graduate Program of Biophotonics-Medicine, Universidade Nove de Julho, Sao Paulo, Brazil1 Postgraduate Program in Biophotonics Appliedto Health Sciences, Nove de Julho University, São Paulo, Brazil3 School of Dentistry, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil3 School of Dentistry, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil4 IFSC (Phisics Institute of São Carlos)5 Brugnera and Zanin Biophotonic Center Institute, São Paulo, BrazilIntroduction In-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 analysis Eighty 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 dissemination This 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.https://bmjopen.bmj.com/content/8/9/e021414.full |
| spellingShingle | Lara Jansiski Motta Anna Carolina Ratto Tempestini Horliana Sandra Kalil Bussadori Maria Fernanda Setúbal Destro Rodrigues Ana Eliza Castanho Garrini dos Santos Marcelo Mendes Pinto Dácio Antonio Pantano Junior Aldo Brugnera Jr Fátima Antonia Aparecida Zanin Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial BMJ Open |
| title | Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial |
| title_full | Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial |
| title_fullStr | Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial |
| title_full_unstemmed | Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial |
| title_short | Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial |
| title_sort | evaluation of in office tooth whitening treatment with violet led protocol for a randomised controlled clinical trial |
| url | https://bmjopen.bmj.com/content/8/9/e021414.full |
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