An interventional study of Carbamide peroxide 16% in Tooyh Discoloration, sponsored by University of Valencia. Not yet recruiting. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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.
University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Carbamide peroxide 16%
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.
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.
Time frame: Baseline to 6 weeks
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.
Time frame: Baseline, 3 weeks, and 6 weeks
Oral Health-Related Quality of Life (OHIP-14)
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.
Time frame: Baseline and 6 weeks
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared because the study involves a small sample size and contains potentially identifiable clinical information.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Valencia