Efficacy and Safety Assessment of Experimental Bleaching Agents

Summary

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.

Conditions

• Tooth Discoloration
• Dentin Sensitivity
• Patient Satisfaction

Interventions

DEVICE

BLEACHING GEL A

Carbomer 940 hydrogel + 6% Hydrogen Peroxide

DEVICE

5% NF_TiO2

Bioactive nanoparticles

DEVICE

BLEACHING GEL B

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide

RADIATION

VISIBLE LIGHT IRRADIATION

Low intensity visible light irradiation (405 nm)

DEVICE

Whiteness HP 35%

Commercially available bleaching gel

DEVICE

Whiteness HP Automixx 6%

Commercially available bleaching gel

Sponsors & Collaborators

• University of Oklahoma

  lead OTHER

Principal Investigators

• Fernando L Esteban Florez, D.D.S., M.S., Ph.D. · The University of Oklahoma Health Sciences Center College of Dentistry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2025-07-31

Completion

2025-09-30

Countries

• United States

Study Locations