Efficacy and Safety Assessment of Experimental Bleaching Agents

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06802614
Status
Not Yet Recruiting

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Conditions

  • Dentin Sensitivity
  • Patient Satisfaction
  • Tooth Discoloration

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • BLEACHING GEL A — DEVICE
    Carbomer 940 hydrogel + 6% Hydrogen Peroxide
  • 5% NF_TiO2 — DEVICE
    Bioactive nanoparticles
  • BLEACHING GEL B — DEVICE
    Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide
  • VISIBLE LIGHT IRRADIATION — RADIATION
    Low intensity visible light irradiation (405 nm)
  • Whiteness HP 35% — DEVICE
    Commercially available bleaching gel
  • Whiteness HP Automixx 6% — DEVICE
    Commercially available bleaching gel

Study Details

Tooth bleaching is widely used to treat the colors of teeth. This study compares the efficiency of two experimental bleaching gels, with and without nanoparticles, and with and without light activation versus two commercial bleaching products of low and high concentrations. The objective is to evaluate tooth color change, sensitivity, and patient satisfaction in patients with moderate yellowing of their teeth. Methods: This is a randomized controlled trial that will include 120 participants aged 18-65 years. Participants will be randomly assigned to one of 12 treatment groups: Gel A (with or without nanoparticles, with or without light), Gel B (with or without nanoparticles, with or without light), Whiteness HP 35% (with or without light) and Whiteness Automixx 6% (with or without light). The primary outcome is tooth color change, measured using a commercially-available equipment. Secondary outcomes will include tooth sensitivity and patient satisfaction. Randomization will be computer-generated. Results: The study is expected to show differences in color change between the experimental and commercial gels. Tooth sensitivity and patient satisfaction will be evaluated to determine the overall effectiveness and safety of the treatments. Conclusions: This trial will provide information into the whitening efficacy of two experimental gels compared to two widely used commercial products.

Key Dates

Start date
Mar 1, 2025
Status verified
Jan 2025
Primary completion
Jul 31, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1. Gel A with nanoparticles, no light.
    An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\_TiO₂) will be applied for 50 minutes.
  • Experimental: 2. Gel A with nanoparticles, with light.
    An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\_TiO₂) + 405 nm violet LED light will be applied for 50 minutes after the gel is applied.
  • Experimental: 3. Gel A without nanoparticles, no light.
    An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide will be applied for 50 minutes.
  • Experimental: 4. Gel A without nanoparticles, with light.
    An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.
  • Experimental: 5. Gel B with nanoparticles, no light.
    Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\_TiO₂) applied for 50 minutes.
  • Experimental: 6. Gel B with nanoparticles, with light.
    Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\_TiO₂) + 405 nm violet LED light applied for 50 minutes.
  • Experimental: 7. Gel B without nanoparticles, no light.
    Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide applied for 50 minutes.
  • Experimental: 8. Gel B without nanoparticles, with light.
    Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.
  • Active Comparator: 9. Whiteness HP 35% no light (control).
    Whiteness HP 35% applied for 30 minutes.
  • Active Comparator: 10. Whiteness HP 35% with light (control).
    Whiteness HP 35% + 405 nm violet LED light applied for 30 minutes.
  • Active Comparator: 11. Whiteness HP AutoMixx 6% no light (control)
    Whiteness HP AutoMixx 6% applied for 30 minutes.
  • Active Comparator: 12. Whiteness HP AutoMixx 6% with light (control)
    Whiteness HP 6% + 405 nm violet LED light applied for 30 minutes.

Primary Outcome Measure

Tooth Color - Delta E [ Time Frame: At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Oklahoma Health Sciences Center College of DentistryOklahoma CityOklahoma73117
Fernando L Esteban Florez, DDS, MS, PhD
[email protected]
405-271-6545

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By research site
The University of Oklahoma Health Sciences Center College of Dentistry· Oklahoma City, OK

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