- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07560761
Contribution of a* to Dental Bleaching After Combined Dental Bleaching
Contribution of the a* Parameter to Dental Bleaching After Combined Bleaching: A Prospective Non-randomized Single-arm Interventional Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: José Amengual-Lorenzo, PhD
- Phone Number: +34616941167
- Email: jose.amengual@uv.es
Study Contact Backup
- Name: Rubén Agustín Panadero, MSc; Phd
- Phone Number: +34653098901
- Email: ruben.agustin@uv.es
Study Locations
-
-
Valencia
-
Valencia, Valencia, Spain, 46010
- University of Valencia
-
Contact:
- José Amengual Lorenzo, Phd
- Phone Number: +34616941167
- Email: jose.amengual@uv.es
-
Contact:
- Rubén Agustín-Panader, MsC; PhD
- Phone Number: +34653098901
- Email: ruben.agustin@uv.es
-
Principal Investigator:
- José Amengual-Lorenzo, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age 18 to 65 years
- Good oral health
- Presence of natural anterior teeth (incisors, canines, premolars)
- Anterior teeth without restorations
- Indication for tooth bleaching treatment
- Ability to comply with study procedures and visits
Exclusion Criteria
- Smoking
- Previous tooth bleaching treatment
- Pregnancy
- Breastfeeding
- Restorations in anterior teeth
- Presence of diseases affecting tooth color
- Conditions that may interfere with study outcomes
Study Plan
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: Combined Dental Bleaching
Participants will undergo a combined dental bleaching treatment consisting of an in-office phase followed by an at-home phase using custom trays.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Whiteness Index for Dentistry (WID)
Time Frame: From baseline to end of treatment (up to 12 weeks).
|
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).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in L* parameter
Time Frame: Baseline to end of treatment (up to 12 weeks).
|
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
Time Frame: Baseline to end of treatment (up to 12 weeks).
|
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
Time Frame: Baseline to end of treatment (up to 12 weeks)
|
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
Time Frame: At end of treatment (up to 12 weeks).
|
Assessment of the relationship between changes in WID and changes in L*, a*, and b*.
|
At end of treatment (up to 12 weeks).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: José Amengual-Lorenzo, University of Valencia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Bleaching_aStar_WID_2026
- Application Reference 2026-ODO (Other Identifier: Ethics Committee University of Valencia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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