Bleaching Agents for Tooth Discoloration

Overseen By Fernando L Esteban Florez, D.D.S., M.S., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Pregnancy, Restorations, Hypersensitivity, Caries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 3 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on dental health and tooth color, so it's best to consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Experimental Bleaching Agents for tooth discoloration?

Research shows that various bleaching agents, including those similar to Experimental Bleaching Agents, are effective in whitening discolored teeth. Studies found that these agents work well in both simple models and actual teeth, with noticeable results after the first application. ^{1 2 3 4 5}

Is tooth bleaching generally safe for humans?

Research shows that tooth bleaching agents can cause stomach irritation if swallowed, but no harm to the liver or kidneys was observed in animal studies. It's important to follow safety guidelines to avoid exceeding safe exposure levels. ^{6 7 8 9 10}

How is the Experimental Bleaching Agents treatment different from other tooth discoloration treatments?

The Experimental Bleaching Agents treatment is unique because it involves a combination of sodium perborate and hydrogen peroxide, which can be applied in different concentrations and methods, such as a thermocatalytic procedure. This approach may offer a more effective and faster whitening process compared to using hydrogen peroxide or sodium perborate alone. ^{1 9 10 11 12}

Research Team

Fernando L Esteban Florez, D.D.S., M.S., Ph.D.

Principal Investigator

The University of Oklahoma Health Sciences Center College of Dentistry

Eligibility Criteria

This trial is for individuals aged 18-65 with moderate tooth yellowing who want to try new bleaching treatments. Participants should be in good general health and have discolored teeth but not severe sensitivity or other dental issues that might affect the results.

Inclusion Criteria

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

I have fillings or other dental work.

History of dentin hypersensitivity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the experimental or control bleaching treatments, with or without nanoparticles and light activation, for 50 minutes per session

3 weeks

4 visits (in-person)

Follow-up

Participants are monitored for tooth color change, sensitivity, and satisfaction after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Experimental Bleaching Agents

Trial Overview The study tests two experimental bleaching gels (with/without nanoparticles, with/without light) against two commercial products at different concentrations. It aims to compare their effectiveness in whitening teeth, impact on sensitivity, and patient satisfaction.

Participant Groups

Group I: 8. Gel B without nanoparticles, with light. Experimental Treatment 2 Interventions

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.

Group II: 7. Gel B without nanoparticles, no light. Experimental Treatment 1 Intervention

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide applied for 50 minutes.

Group III: 6. Gel B with nanoparticles, with light. Experimental Treatment 3 Interventions

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) + 405 nm violet LED light applied for 50 minutes.

Group IV: 5. Gel B with nanoparticles, no light. Experimental Treatment 2 Interventions

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) applied for 50 minutes.

Group V: 4. Gel A without nanoparticles, with light. Experimental Treatment 2 Interventions

An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.

Group VI: 3. Gel A without nanoparticles, no light. Experimental Treatment 1 Intervention

An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide will be applied for 50 minutes.

Group VII: 2. Gel A with nanoparticles, with light. Experimental Treatment 3 Interventions

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.

Group VIII: 1. Gel A with nanoparticles, no light. Experimental Treatment 2 Interventions

An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) will be applied for 50 minutes.

Group IX: 11. Whiteness HP AutoMixx 6% no light (control) Active Control 1 Intervention

Whiteness HP AutoMixx 6% applied for 30 minutes.

Group X: 9. Whiteness HP 35% no light (control). Active Control 1 Intervention

Whiteness HP 35% applied for 30 minutes.

Group XI: 10. Whiteness HP 35% with light (control). Active Control 2 Interventions

Whiteness HP 35% + 405 nm violet LED light applied for 30 minutes.

Group XII: 12. Whiteness HP AutoMixx 6% with light (control) Active Control 2 Interventions

Whiteness HP 6% + 405 nm violet LED light applied for 30 minutes.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[In vitro tests of internal tooth whitening agents on colored solutions do not replace tests on teeth]. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of the Bleaching Efficacy of Different Agents Used for Internal Bleaching: A Systematic Review and Meta-Analysis. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[A review of the effect of tooth bleaching agents on oral microbes]. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Study on the mechanism of discoloration and the efficacy of bleaching in non-infected traumatically discolored teeth]. [2014]

5. South Africa pubmed.ncbi.nlm.nih.gov

Tooth colour change with Ozicure Oxygen Activator: a comparative in vitro tooth bleaching study. [2014]

6. England pubmed.ncbi.nlm.nih.gov

A review of the safety of tooth bleaching. [2018]

7. South Africa pubmed.ncbi.nlm.nih.gov

A review of the safety of tooth bleaching. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Acute toxicity of carbamide peroxide and a commercially available tooth-bleaching agent in rats. [2018]

9. China pubmed.ncbi.nlm.nih.gov

[Effects of vinegar on tooth bleaching and dental hard tissues in vitro]. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Effects of two in-office bleaching agents with different pH values on enamel surface structure and color: an in situ vs. in vitro study. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Bleaching of discolored teeth. Examination and evaluation of the effect of various bleaching agents]. [2013]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Influence of various bleaching regimes on surface roughness of resin composite and ceramic dental biomaterials. [2017]