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NCT06371664

Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment

Completed EARLY_PHASE1 Last updated 17 April 2024
What this trial tests

EARLY_PHASE1 trial testing Conventional Tray (1 mm) in Gingival Inflammation in 72 participants. Completed in 5 April 2023.

Timeline
1 March 2023
Primary endpoint
5 April 2023
5 April 2023

Quick facts

Lead sponsorUniversity of Santiago de Compostela
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment72
Start date1 March 2023
Primary completion5 April 2023
Estimated completion5 April 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

University of Santiago de Compostela

Who can join

18 and older, any sex, with Gingival Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Does the use of a 3-mm extended tray during an at-home bleaching treatment increase gingival irritation? A randomized clinical trial.
    Pereira-Lores P, Martín-González J, Gancedo-Gancedo T, Alonso de la Peña V, et al · · 2025 · cited 2× · PMID 39562219 · DOI 10.1016/j.prosdent.2024.09.029
  2. 12th CONSEURO and the 25th National and 12th International SEOC Congress, April 3-5, 2025, Cordoba, Spain.
    · 2025 · PMID 41431710 · DOI 10.4317/jced.1122335667806

Verify or expand the search:

Other recruiting trials for Gingival Inflammation

Currently open trials in the same condition.

Other University of Santiago de Compostela trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing