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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Tooth Color - Delta E
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
10. Whiteness HP 35% with light (control).
Whiteness HP 35% + 405 nm violet LED light applied for 30 minutes.
干预措施: Whiteness HP 35% (Device)
11. Whiteness HP AutoMixx 6% no light (control)
Whiteness HP AutoMixx 6% applied for 30 minutes.
干预措施: Whiteness HP Automixx 6% (Device)
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.
干预措施: BLEACHING GEL A (Device)
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.
干预措施: 5% NF_TiO2 (Device)
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.
干预措施: BLEACHING GEL A (Device)
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.
干预措施: 5% NF_TiO2 (Device)
10. Whiteness HP 35% with light (control).
Whiteness HP 35% + 405 nm violet LED light applied for 30 minutes.
干预措施: VISIBLE LIGHT IRRADIATION (Radiation)
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.
干预措施: BLEACHING GEL A (Device)
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.
干预措施: VISIBLE LIGHT IRRADIATION (Radiation)
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.
干预措施: BLEACHING GEL A (Device)
9. Whiteness HP 35% no light (control).
Whiteness HP 35% applied for 30 minutes.
干预措施: Whiteness HP 35% (Device)
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.
干预措施: VISIBLE LIGHT IRRADIATION (Radiation)
5. Gel B with nanoparticles, no light.
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) applied for 50 minutes.
干预措施: 5% NF_TiO2 (Device)
5. Gel B with nanoparticles, no light.
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) applied for 50 minutes.
干预措施: BLEACHING GEL B (Device)
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.
干预措施: 5% NF_TiO2 (Device)
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.
干预措施: BLEACHING GEL B (Device)
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.
干预措施: VISIBLE LIGHT IRRADIATION (Radiation)
7. Gel B without nanoparticles, no light.
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide applied for 50 minutes.
干预措施: BLEACHING GEL B (Device)
8. Gel B without nanoparticles, with light.
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.
干预措施: BLEACHING GEL B (Device)
8. Gel B without nanoparticles, with light.
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.
干预措施: VISIBLE LIGHT IRRADIATION (Radiation)
12. Whiteness HP AutoMixx 6% with light (control)
Whiteness HP 6% + 405 nm violet LED light applied for 30 minutes.
干预措施: VISIBLE LIGHT IRRADIATION (Radiation)
12. Whiteness HP AutoMixx 6% with light (control)
Whiteness HP 6% + 405 nm violet LED light applied for 30 minutes.
干预措施: Whiteness HP Automixx 6% (Device)
结局指标
主要结局
Tooth Color - Delta E
时间窗: 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.
Tooth Color - Delta E00
时间窗: 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 - WiD
时间窗: 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.
次要结局
- Patient Satisfaction(at T4 (14 days after T3))
- 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))