Tooyh DiscolorationWID-OHIPNCT07624344
Impact of At-Home Dental Bleaching on Quality of Life Using OHIP-14
A study testing Carbamide peroxide 16% in people with Tooyh Discoloration, run by University of Valencia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooyh Discoloration
- What is being tested?
- Carbamide peroxide 16%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooyh Discoloration
- Being tested
- Carbamide peroxide 16%
- Keywords
- Dental bleaching At-home bleaching Carbamide peroxide WID OHIP-14, CIELAB, Oral health-related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Carbamide peroxide 16% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tooyh DiscolorationStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Amengual Lorenzo, University of Valencia
- Investigators
- José Amangual-Lorenzo, DDS, PhD, Principal investigator, Universitat de ValènciaRubén Agustín-Panadero, DDS, PhD, Study chair, Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624344
- Sponsor's protocol ID
- UV-2026-ODON-4376952-OHIP14
- Acronym
- WID-OHIP
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves a small sample size and contains potentially identifiable clinical information.
Publications
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.
PubMed 26778404Maran 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.
PubMed 39378962Bersezio 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.
PubMed 30132252Pereira 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.
PubMed 35976497
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07624344
- Acronym / sponsor ID
- WID-OHIP / UV-2026-ODON-4376952-OHIP14
- Conditions
- Tooyh Discoloration
- Keywords
- Dental bleaching At-home bleaching Carbamide peroxide WID OHIP-14, CIELAB, Oral health-related quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| At-Home Dental Bleaching | Experimental | Drug: Carbamide peroxide 16%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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 20 and 40 years
- Healthy gums and periodontal condition
- No oral diseases
- No previous dental bleaching treatment
- No restorations in anterior teeth
Key exclusion criteria (6 listed)
- Smoking
- Pregnancy
- Breastfeeding
- Medical conditions that could affect bleaching treatment
- Use of medications that could interfere with bleaching treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | At-Home Dental Bleaching |
Primary outcome
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.
2 secondary outcomes
Changes in CIELAB color parameters (L*, a*, b*)
Time frame: Baseline, 3 weeks, and 6 weeks
Oral Health-Related Quality of Life (OHIP-14)
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 26778404Perez 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.
- Background: PubMed 39378962Maran 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.
- Background: PubMed 30132252Bersezio 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.
- Background: PubMed 35976497Pereira 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves a small sample size and contains potentially identifiable clinical information.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José Amangual-Lorenzo, DDS, PhD principal investigator
Universitat de València
Rubén Agustín-Panadero, DDS, PhD study chair
Universitat de València
Questions about this trial
What is this clinical trial studying?
A study testing Carbamide peroxide 16% in people with Tooyh Discoloration, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Amengual-Lorenzo, DDS, PhD (+34 616941167, jose.amengual@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Whiteness Index for Dentistry (WID) (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07624344, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.