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Contribution of a* to Dental Bleaching After Combined Dental Bleaching

30. april 2026 opdateret af: José Amengual Lorenzo, University of Valencia

Contribution of the a* Parameter to Dental Bleaching After Combined Bleaching: A Prospective Non-randomized Single-arm Interventional Clinical Study

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Rubén Agustín Panadero, MSc; Phd
  • Telefonnummer: +34653098901
  • E-mail: ruben.agustin@uv.es

Studiesteder

  • Spanien
    • Valencia
      • Valencia, Valencia, Spanien, 46010
        • University of Valencia
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • José Amengual-Lorenzo, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Whiteness Index for Dentistry (WID)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in L* parameter
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Valencia

Efterforskere

  • Ledende efterforsker: José Amengual-Lorenzo, University of Valencia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

25. marts 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Bleaching_aStar_WID_2026
  • Application Reference 2026-ODO (Anden identifikator: Ethics Committee University of Valencia)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Combined Dental Bleaching

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