- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: José Amengual-Lorenzo, PhD
- Telefonnummer: +34616941167
- E-post: jose.amengual@uv.es
Studera Kontakt Backup
- Namn: Rubén Agustín Panadero, MSc; Phd
- Telefonnummer: +34653098901
- E-post: ruben.agustin@uv.es
Studieorter
-
-
Valencia
-
Valencia, Valencia, Spanien, 46010
- University of Valencia
-
Kontakt:
- José Amengual Lorenzo, Phd
- Telefonnummer: +34616941167
- E-post: jose.amengual@uv.es
-
Kontakt:
- Rubén Agustín-Panader, MsC; PhD
- Telefonnummer: +34653098901
- E-post: ruben.agustin@uv.es
-
Huvudutredare:
- José Amengual-Lorenzo, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Whiteness Index for Dentistry (WID)
Tidsram: 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in L* parameter
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: José Amengual-Lorenzo, University of Valencia
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Bleaching_aStar_WID_2026
- Application Reference 2026-ODO (Annan identifierare: Ethics Committee University of Valencia)
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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