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| ID | Type | Description | Link |
|---|---|---|---|
| Application Reference 2026-ODO | Other Identifier | Ethics Committee University of Valencia |
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A prospective, non-randomized, single-arm interventional clinical study with a before-after design will be conducted to assess changes in CIELab color parameters and the Whiteness Index for Dentistry (WID) following a standardized combined dental bleaching protocol. The study aims to evaluate the contribution of the a* parameter (green-red axis) to overall dental whiteness.
Tooth whitening is one of the most commonly requested aesthetic dental treatments, requiring objective and reproducible methods to quantify color changes. The CIELab color system (L*, a*, b*) and the Whiteness Index for Dentistry (WID) are widely used for this purpose.
While increases in L* and decreases in b* are recognized as the main contributors to dental whitening, the role of the a* parameter remains unclear. Variations in a*, including the presence of negative values or changes in sign during treatment, have been insufficiently studied.
A prospective, non-randomized, single-arm interventional clinical study with a before-after design will be conducted to evaluate changes in L*, a*, b*, and WID following a combined dental bleaching protocol consisting of an in-office phase with hydrogen peroxide and an at-home phase with carbamide peroxide.
Spectrophotometric measurements will be performed at baseline, after the in-office phase, and after completion of the at-home phase. The study will also analyze the relationship between changes in CIELab parameters and WID.
The study will be conducted in accordance with ethical standards and will be approved by the corresponding institutional review board. All participants will provide written informed consent prior to inclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Dental Bleaching | Experimental | Participants will undergo a combined dental bleaching treatment consisting of an in-office phase followed by an at-home phase using custom trays. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Dental Bleaching | Procedure | The intervention consists of an in-office bleaching phase with two 20-minute applications of 40% hydrogen peroxide, followed by an at-home bleaching phase using 16% carbamide peroxide applied with custom trays for 90 minutes daily. Treatment will continue until color stabilization is achieved, defined as a change in WID of less than 2.6 units between two consecutive weekly measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Whiteness Index for Dentistry (WID) | Change in WID values calculated from CIELab parameters (L*, a*, b*) between baseline and the end of treatment (up to 12 weeks). | From baseline to end of treatment (up to 12 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in L* parameter | Difference in L* values between baseline and the end of treatment (up to 12 weeks) measured using spectrophotometry. | Baseline to end of treatment (up to 12 weeks). |
| Change in a* parameter |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Amengual-Lorenzo, PhD | Contact | +34616941167 | jose.amengual@uv.es | |
| Rubén Agustín Panadero, MSc; Phd | Contact | +34653098901 | ruben.agustin@uv.es |
| Name | Affiliation | Role |
|---|---|---|
| José Amengual-Lorenzo | University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Valencia | Valencia | Valencia | 46010 | Spain |
| 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. |
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Individual participant data will not be shared, as this is not necessary to achieve the study's objectives or to interpret the results. All findings will be summarized statistically without revealing individual participant information, thereby ensuring privacy and confidentiality. Individual anonymized data will not be shared, as aggregated data is sufficient to ensure scientific transparency and the reproducibility of the results.
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Difference in a* values between baseline and the end of treatment (up to 12 weeks), including assessment of sign changes.
| Baseline to end of treatment (up to 12 weeks). |
| Change in b* parameter | Difference in b* values between baseline and the end of treatment (up to 12 weeks), measured using spectrophotometry. | Baseline to end of treatment (up to 12 weeks) |
| Correlation between WID and CIELab parameters | Assessment of the relationship between changes in WID and changes in L*, a*, and b*. | At end of treatment (up to 12 weeks). |