NCT07560761

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
9mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

March 25, 2026

Last Update Submit

April 30, 2026

Conditions

Healthy

Keywords

Dental bleachingTooth colorCIELabWhiteness IndexSpectrophotometry

Outcome Measures

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).

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

Secondary Outcomes (4)

  • Change in L* parameter

    Baseline to end of treatment (up to 12 weeks).

  • Change in a* parameter

    Baseline to end of treatment (up to 12 weeks).

  • Change in b* parameter

    Baseline to end of treatment (up to 12 weeks)

  • Correlation between WID and CIELab parameters

    At end of treatment (up to 12 weeks).

Study Arms (1)

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.

Procedure: Combined Dental Bleaching

Interventions

Combined Dental BleachingPROCEDURE

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.

Combined Dental Bleaching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smoking
  • Previous tooth bleaching treatment
  • Pregnancy
  • Breastfeeding
  • Restorations in anterior teeth
  • Presence of diseases affecting tooth color
  • Conditions that may interfere with study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26778404BACKGROUND

Study Officials

  • José Amengual-Lorenzo

    University of Valencia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José Amengual-Lorenzo, PhD

CONTACT

+34616941167jose.amengual@uv.es

Rubén Agustín Panadero, MSc; Phd

CONTACT

+34653098901ruben.agustin@uv.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Stomatology

Study Record Dates

First Submitted

March 25, 2026

First Posted

May 1, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)