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This prospective clinical study aims to evaluate the clinical efficacy of an at-home dental bleaching protocol and its impact on oral health-related quality of life using objective color measurements and patient-reported outcomes. Changes in tooth color will be assessed using CIELAB parameters (L*, a*, b*) and the Whiteness Index for Dentistry (WID), while quality of life will be evaluated using the OHIP-14 questionnaire.
Tooth bleaching is a widely used minimally invasive treatment for improving dental aesthetics. Objective evaluation of color changes is essential and is commonly performed using the CIELAB color space and derived indices such as the Whiteness Index for Dentistry (WID).
This study will be designed as a prospective, non-randomized before-after clinical trial to evaluate the clinical efficacy of an at-home dental bleaching protocol and its effect on tooth color. The protocol will consist of the at-home application of 16% carbamide peroxide delivered through custom trays for six weeks, with one daily application lasting 90 minutes.
The primary objectives of this study will be to quantify color changes and bleaching effectiveness, as well as to evaluate oral health-related quality of life and the subjective impact of treatment. Additional analyses will include a detailed assessment of the behavior of the individual CIELAB parameters and their variation during treatment, the analysis of correlations between WID and the individual color parameters, and the evaluation of oral health-related quality of life using the OHIP-14 questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| At-Home Dental Bleaching | Experimental | Los participantes serán sometidos a un tratamiento de blanqueamiento dental domiciliario utilizando peróxido de carbamida al 16% aplicado mediante férulas individualizadas durante seis semanas, con una aplicación diaria de 90 minutos. Los cambios en el color dentario se evaluarán mediante mediciones espectrofotométricas de los parámetros CIELAB (L*, a*, b*) y del Índice de Blancura para Dentistas (WID). La calidad de vida relacionada con la salud oral también se evaluará mediante el cuestionario OHIP-14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbamide peroxide 16% | Drug | Blanqueamiento dental domiciliario utilizando peróxido de carbamida al 16% aplicado mediante férulas individualizadas durante seis semanas, con una aplicación diaria de 90 minutos. Los cambios en el color dentario se evaluarán mediante mediciones espectrofotométricas de los parámetros CIELAB (L*, a*, b*) y del Índice de Blancura para Dentistas (WID). La calidad de vida relacionada con la salud oral también se evaluará mediante el cuestionario OHIP-14. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Whiteness Index for Dentistry (WID) | Change in dental whiteness measured using the Whiteness Index for Dentistry (WID) calculated from the CIELAB color parameters (L*, a*, b*) obtained by spectrophotometry before and after at-home dental bleaching treatment. | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CIELAB color parameters (L*, a*, b*) | Objective color changes measured using spectrophotometric evaluation of the CIELAB color parameters (L*, a*, b*) during at-home dental bleaching treatment. | Baseline, 3 weeks, and 6 weeks |
| Oral Health-Related Quality of Life (OHIP-14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Amengual-Lorenzo, DDS, PhD | Contact | +34 616941167 | jose.amengual@uv.es | |
| Rubén Agustín-Panadero, DDS, PhD | Contact | +34 653098901 | ruben.agustin@uv.es |
| Name | Affiliation | Role |
|---|---|---|
| José Amangual-Lorenzo, DDS, PhD | Universitat de València | Principal Investigator |
| Rubén Agustín-Panadero, DDS, PhD | Universitat de València | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26778404 | Background | Perez Mdel M, Ghinea R, Rivas MJ, Yebra A, Ionescu AM, Paravina RD, Herrera LJ. Development of a customized whiteness index for dentistry based on CIELAB color space. Dent Mater. 2016 Mar;32(3):461-7. doi: 10.1016/j.dental.2015.12.008. Epub 2016 Jan 6. | |
| 39378962 | Background | Maran BM, Bersezio C, Martin J, Favoreto MW, Rezende M, Vallejo-Izquierdo L, Reis A, Loguercio AD, Fernandez E. The influence of dental bleaching on patient's quality of life: A multistudy analysis of aesthetic and psychosocial outcomes. J Dent. 2024 Dec;151:105397. doi: 10.1016/j.jdent.2024.105397. Epub 2024 Oct 6. |
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Individual participant data will not be shared because the study involves a small sample size and contains potentially identifiable clinical information.
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All participants will receive the same at-home dental bleaching treatment using 16% carbamide peroxide delivered through custom trays for six weeks. Color changes and oral health-related quality of life will be evaluated before and after treatment.
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Oral health-related quality of life will be assessed using the OHIP-14 questionnaire at baseline and after 6 weeks of at-home dental bleaching. Changes in OHIP-14 scores will be used to evaluate the impact of treatment on patients' oral health-related quality of life. |
| Baseline and 6 weeks |
| 30132252 | Background | Bersezio C, Martin J, Mayer C, Rivera O, Estay J, Vernal R, Haidar ZS, Angel P, Oliveira OB Jr, Fernandez E. Quality of life and stability of tooth color change at three months after dental bleaching. Qual Life Res. 2018 Dec;27(12):3199-3207. doi: 10.1007/s11136-018-1972-7. Epub 2018 Aug 21. |
| 35976497 | Background | Pereira R, Silveira J, Dias S, Cardoso A, Mata A, Marques D. Bleaching efficacy and quality of life of different bleaching techniques - randomized controlled trial. Clin Oral Investig. 2022 Dec;26(12):7167-7177. doi: 10.1007/s00784-022-04678-5. Epub 2022 Aug 17. |