Bleaching Agents for Tooth Discoloration

Recruiting in Palo Alto (17 mi)

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

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Oklahoma

No Placebo Group

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.

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

Treatment Details

Interventions

• Experimental Bleaching Agents (Bleaching Agent)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Oklahoma Health Sciences Center College of Dentistry Oklahoma City, OK

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Patients Recruited

95,900+