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

May 31, 2026 updated by: José Amengual Lorenzo, University of Valencia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: José Amengual-Lorenzo, DDS, PhD
  • Phone Number: +34 616941167
  • Email: jose.amengual@uv.es

Study Contact Backup

  • Name: Rubén Agustín-Panadero, DDS, PhD
  • Phone Number: +34 653098901
  • Email: ruben.agustin@uv.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: At-Home Dental Bleaching
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Whiteness Index for Dentistry (WID)
Time Frame: Baseline to 6 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in CIELAB color parameters (L*, a*, b*)
Time Frame: Baseline, 3 weeks, and 6 weeks
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)
Time Frame: Baseline and 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: José Amangual-Lorenzo, DDS, PhD, Universitat de València
  • Study Chair: Rubén Agustín-Panadero, DDS, PhD, Universitat de València

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

May 25, 2026

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UV-2026-ODON-4376952-OHIP14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study involves a small sample size and contains potentially identifiable clinical information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tooyh Discoloration

Clinical Trials on Carbamide peroxide 16%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe