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Not yet recruitingNCT07560761Updated May 6, 2026

Contribution of a* to Dental Bleaching After Combined Dental Bleaching

An interventional study of Combined Dental Bleaching in Healthy, sponsored by University of Valencia. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Dental bleaching
  • Tooth color
  • CIELab
  • Whiteness Index
  • Spectrophotometry
03

In context

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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.

    Procedure: Combined Dental Bleaching

Interventions

  • ProcedureCombined Dental Bleaching

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From baseline to end of treatment (up to 12 weeks).

Secondary outcomes

  1. Change in L* parameter

    Difference in L\* values between baseline and the end of treatment (up to 12 weeks) measured using spectrophotometry.

    Time frame: Baseline to end of treatment (up to 12 weeks).

  2. Change in a* parameter

    Difference in a\* values between baseline and the end of treatment (up to 12 weeks), including assessment of sign changes.

    Time frame: Baseline to end of treatment (up to 12 weeks).

  3. Change in b* parameter

    Difference in b\* values between baseline and the end of treatment (up to 12 weeks), measured using spectrophotometry.

    Time frame: Baseline to end of treatment (up to 12 weeks)

  4. Correlation between WID and CIELab parameters

    Assessment of the relationship between changes in WID and changes in L\*, a\*, and b\*.

    Time frame: At end of treatment (up to 12 weeks).

07

Study locations

1 site
  • University of Valencia
    Valencia, Valencia 46010, Spain
    • José Amengual Lorenzo, Phd · Contact · jose.amengual@uv.es · +34616941167
    • Rubén Agustín-Panader, MsC; PhD · Contact · ruben.agustin@uv.es · +34653098901
    • José Amengual-Lorenzo, PhD · Principal investigator
08

References and documents

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 26778404 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07560761
Lead sponsor
University of Valencia
Responsible party
José Amengual Lorenzo (Assistant Professor of Stomatology, University of Valencia) — Principal investigator
First posted
May 1, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
May 6, 2026

Study contacts

José Amengual-Lorenzo, PhD
Contact
jose.amengual@uv.es
+34616941167
Rubén Agustín Panadero, MSc; Phd
Contact
ruben.agustin@uv.es
+34653098901
José Amengual-Lorenzo
principal investigator · University of Valencia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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