Peroxide Versus Non-Peroxide In-Office Tooth Bleaching: A Randomized Clinical Trial (BECTS)
8. september 2026 oppdatert av: Esraa Eid Qurany, Minia University
Bleaching Efficacy, Color Durability, and Tooth Sensitivity After In-Office Bleaching With Peroxide Versus Non-Peroxide Systems: A Randomized Clinical Trial
This randomized clinical trial aims to compare the effectiveness of peroxide and non-peroxide in-office tooth bleaching systems.
The study will evaluate tooth whitening efficacy, color durability over time, and tooth sensitivity after treatment.
Participants will receive one of the two bleaching treatments and will be followed for six months to assess the clinical outcomes and compare the performance of both systems.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
This randomized controlled clinical trial is designed to compare the clinical performance of peroxide-based and non-peroxide in-office tooth bleaching systems.
Eligible participants will be randomly allocated into two treatment groups.
Tooth color will be assessed using standardized clinical evaluation methods before treatment, immediately after bleaching, and during follow-up visits.
The study will also evaluate color stability and tooth sensitivity over a six-month follow-up period.
The findings are expected to provide evidence regarding the effectiveness and safety of both bleaching systems and to support evidence-based clinical decision-making in esthetic dentistry.
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Esraa Eid, MSc
- Telefonnummer: +20 1019243773
- E-post: esraa.korny@nub.edu.eg
Studiesteder
-
-
Minya Governorate
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Minya, Minya Governorate, Egypt
- Rekruttering
- Minia University Hospital
-
Ta kontakt med:
- Esraa Eid, MSc
- Telefonnummer: +20 1019243773
- E-post: esraa.korny@nub.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Adults aged 18-45 years.
- Good general health.
- Presence of all maxillary anterior teeth free from restorations, caries, or structural defects.
- Baseline tooth shade suitable for bleaching assessment.
- Good oral hygiene and periodontal health.
- Willingness to comply with the study protocol and attend all follow-up visits.
- Signed informed consent.
Exclusion Criteria:
- Pregnancy or lactation.
- History of tooth hypersensitivity.
- Active caries or defective restorations in the anterior teeth.
- Intrinsic tooth discoloration (e.g., fluorosis, tetracycline staining).
- Ongoing orthodontic treatment.
- Smoking.
- Use of tooth-whitening products within the previous 6 months.
- Allergy to any component of the bleaching materials.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Peroxide-based in office bleaching
Participants will receive a peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions.
|
Participants will receive an in-office peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.
|
|
Eksperimentell: Non-peroxide-based in office bleaching
Participants will receive a non-peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions.
|
Participants will receive an in-office non- peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bleaching efficacy measured by Whiteness Index for Dentistry (WID)
Tidsramme: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
|
Bleaching efficacy will be assessed using the Whiteness Index for Dentistry (WID) obtained by spectrophotometric measurements of the anterior teeth.
|
Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
|
|
Color durability measured by CIEDE2000 color difference (ΔE00)
Tidsramme: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
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Color durability will be evaluated using spectrophotometric color measurements and expressed as CIEDE2000 color difference (ΔE00).
|
Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
|
|
Tooth sensitivity assessed using the Visual Analog Scale (VAS)
Tidsramme: Daily during the 14-day treatment period
|
ooth sensitivity will be evaluated using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain
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Daily during the 14-day treatment period
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. august 2026
Primær fullføring (Antatt)
15. februar 2027
Studiet fullført (Antatt)
15. mars 2027
Datoer for studieregistrering
Først innsendt
8. september 2026
Først innsendt som oppfylte QC-kriteriene
8. september 2026
Først lagt ut (Faktiske)
14. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MU-1301-2026
- 1301/2026 (Annen identifikator: Research Ethics Committee, Faculty of Dentistry, Minia University)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
individual participant data will not be shared because there is no plan for public data sharing beyond the analyses and results reported in the study.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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