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Impact of At-Home Dental Bleaching on Quality of Life Using OHIP-14

Clinical Evaluation of Color Changes (CIELAB),Whiteness Index (WID), and Oral Health-Related Quality of Life (OHIP-14) Following At-home Dental Bleaching: A Prospective Clinical Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07624344
Acronym
WID-OHIP
Enrollment
10
Registered
2026-06-03
Start date
2026-11-01
Completion date
2027-07-31
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooyh Discoloration

Keywords

Dental bleaching At-home bleaching Carbamide peroxide WID OHIP-14, CIELAB, Oral health-related quality of life

Brief summary

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.

Detailed description

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.

Interventions

DRUGCarbamide 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.

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Age between 20 and 40 years * Healthy gums and periodontal condition * No oral diseases * No previous dental bleaching treatment * No restorations in anterior teeth * Ability to attend follow-up visits * Willingness to follow the study instructions

Exclusion criteria

* Smoking * Pregnancy * Breastfeeding * Medical conditions that could affect bleaching treatment * Use of medications that could interfere with bleaching treatment * Inability to comply with scheduled appointments

Design outcomes

Primary

MeasureTime frameDescription
Change in Whiteness Index for Dentistry (WID)Baseline to 6 weeksChange 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.

Secondary

MeasureTime frameDescription
Changes in CIELAB color parameters (L*, a*, b*)Baseline, 3 weeks, and 6 weeksObjective color changes measured using spectrophotometric evaluation of the CIELAB color parameters (L\*, a\*, b\*) during at-home dental bleaching treatment.
Oral Health-Related Quality of Life (OHIP-14)Baseline and 6 weeksOral 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.

Contacts

CONTACTJosé Amengual-Lorenzo, DDS, PhD
jose.amengual@uv.es+34 616941167
CONTACTRubén Agustín-Panadero, DDS, PhD
ruben.agustin@uv.es+34 653098901
PRINCIPAL_INVESTIGATORJosé Amangual-Lorenzo, DDS, PhD

Universitat de València

STUDY_CHAIRRubén Agustín-Panadero, DDS, PhD

Universitat de València

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026