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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of two new tooth bleaching gels (experimental bleaching agents) compared to two popular commercial products. It will evaluate how well these treatments change tooth color and their effects on sensitivity and user satisfaction. Participants will try different combinations of the gels, with or without nanoparticles (tiny particles), and with or without light activation. Individuals with moderate tooth yellowing, who do not have fillings or sensitivity issues and do not smoke or vape, might be suitable for this trial. As an unphased trial, this study allows participants to explore innovative tooth whitening options before they become widely available.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tooth whitening gels with hydrogen peroxide are usually well-tolerated. The most common side effects include tooth sensitivity and gum irritation. For Gel A, which contains Carbomer 940 and 6% hydrogen peroxide, past research has not identified major safety issues. Similarly, Gel B, which includes Hyaluronic Acid and the same amount of hydrogen peroxide, demonstrated less cell damage when used with nanoparticles and light.

Hydrogen peroxide is already widely used in dental products, and these gels are being tested with similar amounts, suggesting they are likely safe. However, like many dental treatments, some temporary sensitivity may occur. It is advisable to consult a dentist about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore innovative ways to tackle tooth discoloration using advanced bleaching gels. Unlike traditional whitening treatments that mostly rely on hydrogen peroxide alone, these experimental gels incorporate nanoparticles, which could enhance the bleaching effect. Additionally, some treatments use violet LED light to potentially boost the whitening process further. These unique features might offer a more effective and quicker whitening experience compared to standard options like over-the-counter whitening strips or professional peroxide treatments.

What evidence suggests that this trial's treatments could be effective for tooth discoloration?

This trial will compare various bleaching agents for tooth discoloration. Studies have shown that bleaching gels with 6% hydrogen peroxide effectively whiten teeth. In this trial, some participants will receive Gel A, which combines a thickening agent called Carbomer 940 with nanoparticles and showed a noticeable change in tooth color in previous research. Others will receive Gel B, which uses hyaluronic acid and nanoparticles and demonstrated similar whitening results. Additionally, the trial tests a violet LED light to enhance the effectiveness of both gels. Overall, these experimental gels promise noticeable tooth whitening. ^{1 4 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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

History of dentin hypersensitivity

Use of substances that could affect tooth color during the trial, such as smoking and vaping

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06802614?term=AREA%5BBasicSearch%5D(viola%20to%20color)&rank=5

Efficacy and Safety Assessment of Experimental Bleaching ... This study compares the efficacy of two experimental bleaching gels, Gel A (Carbomer 940 + 6% Hydrogen Peroxide) and Gel B (Hyaluronic Acid + 6% Hydrogen ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12315631/

Hyaluronic Acid‐Based Bleaching Gels With NF_TiO2 and ... Objective. To evaluate the efficacy and cytotoxicity of in‐office bleaching gels with hyaluronic acid (HA) or carbomer 940 (CAR), titanium ...

3. researchgate.net researchgate.net/publication/395448407_Clinical_Performance_of_Low-Concentration_Bleaching_Gels_with_Hyaluronic_Acid_and_NF_TiO2_Nanoparticles_Activated_by_Violet_LED_A_Randomized_Clinical_Trial

Clinical Performance of Low-Concentration Bleaching Gels ... This study evaluated the photoactivation of hydrogen peroxide gels at different concentrations using blue or violet LED in terms of whitening efficacy and tooth ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2836817/

Comparative Clinical Study of Two Tooth Bleaching Protocols ... Treatment with 6% hydrogen peroxide gel using the paint-on system shows significant clinical efficacy whether applied by clinicians or by the patients ...

5. mdpi.com mdpi.com/2076-3417/13/12/7089

Efficacy of Carbamide and Hydrogen Peroxide Tooth ... Conclusion: Carbamide and hydrogen peroxide based whitening techniques were shown to be equally successful at treating tooth discoloration after bracket ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/14738835/

Safety evaluation of a novel whitening gel, containing 6% ... Objectives: The aim of this study was to compare the effect on oral soft tissue of a self-applied tooth whitening gel containing 6% hydrogen peroxide (Xtra ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jerd.13484

Hyaluronic Acid‐Based Bleaching Gels With NF_TiO2 and ... To evaluate the efficacy and cytotoxicity of in-office bleaching gels with hyaluronic acid (HA) or carbomer 940 (CAR), titanium dioxide ...

8. mdpi.com mdpi.com/1422-0067/24/3/1956

Effectiveness and Safety of Over-the-Counter Tooth ... This study investigated the whitening effect, cytotoxicity and enamel surface alterations induced by different over-the-counter (OTC) bleaching agents in ...