Dentin Sensitivity, Patient Satisfaction, Tooth Discoloration
Conditions
Keywords
Tooth Whitenining, Dental Bleaching, Hydrogen Peroxide, Titanium Dioxide Nanoparticles
Brief 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.
Detailed 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. Methods: This is a randomized controlled trial that will include 200 participants aged 18-65 years with mild to moderate tooth discoloration. Participants will be randomly assigned to one of 10 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 the Vita EasyShade V system to assess ΔE, ΔE00, and Whiteness Index for Dentistry (WiD). Secondary outcomes will include tooth sensitivity (measured with a Visual Analog Scale) and patient satisfaction (assessed via post-treatment questionnaire). Randomization will be computer-generated, and the study will be double-blinded for evaluators. Results: The study is expected to detect significant differences in color change between the experimental gels and Whiteness HP 35%, with or without nanoparticles and light activation. Tooth sensitivity and patient satisfaction will be evaluated to determine the overall effectiveness and safety of the treatments. Conclusions: This trial will provide insights into the whitening efficacy of two experimental gels compared to a widely used commercial product. The inclusion of nanoparticles and light activation as variables will help determine the optimal conditions for effective tooth bleaching in patients with moderate discoloration. The results will contribute to evidence-based recommendations for aesthetic dental treatments.
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
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be a randomized, parallel-arm clinical trial that compares the efficacy of the two experimental bleaching gels, with and without nanoparticles, versus two commercial products that serve as the control groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tooth Color - WiD | At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3) | WiD; This outcome measure is dimensionless and will be extracted from L\*, a\* and b\* values. |
| Tooth Color - Delta E00 | At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3) | Delta E00; This outcome measure is dimensionless and will be extracted from L\*, a\* and b\* values. |
| Tooth Color - Delta E | At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3) | Delta E ; This outcome measure is dimensionless and will be extracted from L\*, a\* and b\* values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tooth sensitivity | At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3) | Visual Analog Scale (VAS). The scale will vary from 0 (no pain) to 10 (worst pain possible). In this outcome measure, higher scores reflect outcomes that are worse in nature |
| Patient Satisfaction | at T4 (14 days after T3) | Post-treatment questionnaire. |
Countries
United States
Contacts
Primary ContactFernando L Esteban Florez, D.D.S., M.S., Ph.D.
Outcome results
None listed