A Randomized Controlled Clinical Trial Comparing the Efficacy of Two Experimental Bleaching Gels With and Without Nanoparticles and Light Irradiation Versus Whiteness HP 35% and Whiteness HP AutoMixx 6% in Patients With A2-C4 Tooth Discolorations
University of Oklahoma
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.
Description
Tooth whitening treatments are widely used to address dental discoloration. This study compares the efficacy of two experimental bleaching gels, Gel A (Carbomer 940 + 6% Hydrogen Peroxide) and Gel B (Hyaluronic Acid + 6% Hydrogen Peroxide), with and without 5% of NF\_TiO₂ nanoparticles, and with and without light activation (405 nm, 30 min) versus a control bleaching product (Whiteness HP 35%, FGM). The aim is to evaluate tooth color change, sensitivity, and patient satisfaction in patients with baseline tooth discoloration ranging from shades A3 to C4 on the Vita Classical Shade Guide. Method…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age: 18-65 years old. * Healthy periodontal tissues. * Willingness to participate and follow the post-treatment protocols. * Ability to provide informed consent. * Teeth having baseline colors ranging from shade A2 to C4 Exclusion Criteria: * Pregnant or breastfeeding women. * Teeth with restorations. * History of dentin hypersensitivity. * Active caries, periodontal disease or endodontically treated teeth. * Use of substances that could affect tooth color during the trial, such as smoking and vaping.
Interventions
- DeviceBLEACHING GEL A
Carbomer 940 hydrogel + 6% Hydrogen Peroxide
- Device5% NF_TiO2
Bioactive nanoparticles
- DeviceBLEACHING GEL B
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide
- RadiationVISIBLE LIGHT IRRADIATION
Low intensity visible light irradiation (405 nm)
- DeviceWhiteness HP 35%
Commercially available bleaching gel
- DeviceWhiteness HP Automixx 6%
Commercially available bleaching gel
Location
- The University of Oklahoma Health Sciences Center College of DentistryOklahoma City, Oklahoma