Efficacy and Safety Assessment of Experimental Bleaching Agents

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dentin Sensitivity; Patient Satisfaction; Tooth Discoloration
• Intervention / Treatment: Device: BLEACHING GEL A; Device: 5% NF_TiO2; Radiation: VISIBLE LIGHT IRRADIATION; Device: BLEACHING GEL B; Device: Whiteness HP 35%; Device: Whiteness HP Automixx 6%

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando L Esteban Florez, D.D.S., M.S., Ph.D.; Phone Number: 48646 (405)271-6545; Email: fernando-esteban-florez@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • The University of Oklahoma Health Sciences Center College of Dentistry
      • Contact: Fernando L Esteban Florez, DDS, MS, PhD; Phone Number: 48646 405-271-6545; Email: festeban@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: BLEACHING GEL A; Carbomer 940 hydrogel + 6% Hydrogen Peroxide; Device: 5% NF_TiO2; Bioactive nanoparticles
Experimental: 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.	Device: BLEACHING GEL A; Carbomer 940 hydrogel + 6% Hydrogen Peroxide; Device: 5% NF_TiO2; Bioactive nanoparticles; Radiation: VISIBLE LIGHT IRRADIATION; Low intensity visible light irradiation (405 nm)
Experimental: 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.	Device: BLEACHING GEL A; Carbomer 940 hydrogel + 6% Hydrogen Peroxide
Experimental: 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.	Device: BLEACHING GEL A; Carbomer 940 hydrogel + 6% Hydrogen Peroxide; Radiation: VISIBLE LIGHT IRRADIATION; Low intensity visible light irradiation (405 nm)
Experimental: 5. Gel B with nanoparticles, no light.; Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) applied for 50 minutes.	Device: 5% NF_TiO2; Bioactive nanoparticles; Device: BLEACHING GEL B; Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide
Experimental: 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.	Device: 5% NF_TiO2; Bioactive nanoparticles; Radiation: VISIBLE LIGHT IRRADIATION; Low intensity visible light irradiation (405 nm); Device: BLEACHING GEL B; Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide
Experimental: 7. Gel B without nanoparticles, no light.; Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide applied for 50 minutes.	Device: BLEACHING GEL B; Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide
Experimental: 8. Gel B without nanoparticles, with light.; Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.	Radiation: VISIBLE LIGHT IRRADIATION; Low intensity visible light irradiation (405 nm); Device: BLEACHING GEL B; Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide
Active Comparator: 9. Whiteness HP 35% no light (control).; Whiteness HP 35% applied for 30 minutes.	Device: Whiteness HP 35%; Commercially available bleaching gel
Active Comparator: 10. Whiteness HP 35% with light (control).; Whiteness HP 35% + 405 nm violet LED light applied for 30 minutes.	Radiation: VISIBLE LIGHT IRRADIATION; Low intensity visible light irradiation (405 nm); Device: Whiteness HP 35%; Commercially available bleaching gel
Active Comparator: 11. Whiteness HP AutoMixx 6% no light (control); Whiteness HP AutoMixx 6% applied for 30 minutes.	Device: Whiteness HP Automixx 6%; Commercially available bleaching gel
Active Comparator: 12. Whiteness HP AutoMixx 6% with light (control); Whiteness HP 6% + 405 nm violet LED light applied for 30 minutes.	Radiation: VISIBLE LIGHT IRRADIATION; Low intensity visible light irradiation (405 nm); Device: Whiteness HP Automixx 6%; Commercially available bleaching gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth Color - Delta E	Delta E ; This outcome measure is dimensionless and will be extracted from L*, a* and b* values.	At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
Tooth Color - Delta E00	Delta E00; This outcome measure is dimensionless and will be extracted from L*, a* and b* values.	At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
Tooth Color - WiD	WiD; This outcome measure is dimensionless and will be extracted from L*, a* and b* values.	At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth sensitivity	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	At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
Patient Satisfaction	Post-treatment questionnaire.	at T4 (14 days after T3)

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Fernando L Esteban Florez, D.D.S., M.S., Ph.D., The University of Oklahoma Health Sciences Center College of Dentistry

Publications and helpful links

General Publications

• Kury M, Hiers RD, Zhao YD, Picolo MZD, Hsieh J, Khajotia SS, Esteban Florez FL, Cavalli V. Novel Experimental In-Office Bleaching Gels Containing Co-Doped Titanium Dioxide Nanoparticles. Nanomaterials (Basel). 2022 Aug 30;12(17):2995. doi: 10.3390/nano12172995.
• Matos ICRT, Kury M, de Melo PBG, de Souza LVS, Esteban Florez FL, Cavalli V. Effects of experimental bleaching gels containing co-doped titanium dioxide and niobium pentoxide combined with violet light. Clin Oral Investig. 2023 Aug;27(8):4827-4841. doi: 10.1007/s00784-023-05113-z. Epub 2023 Jun 28.
• Kury M, Esteban Florez FL, Tabchoury CPM, Cavalli V. Effects of experimental in-office bleaching gels incorporated with co-doped titanium dioxide nanoparticles on dental enamel physical properties. Odontology. 2025 Jan;113(1):318-330. doi: 10.1007/s10266-024-00976-4. Epub 2024 Jul 4.
• Kury M, de Oliveira Ribeiro RA, de Souza Costa CA, Florez FLE, Cavalli V. Co-doped titanium dioxide nanoparticles decrease the cytotoxicity of experimental hydrogen peroxide gels for in-office tooth bleaching. Clin Oral Investig. 2024 Sep 25;28(10):550. doi: 10.1007/s00784-024-05916-8.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Hydrogen Peroxide; Dental Bleaching; Tooth Whitenining; Titanium Dioxide Nanoparticles
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dentin Sensitivity; Tooth Discoloration
• Other Study ID Numbers: OUCOD001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share individual data. We plan on sharing data that have been statistically analyzed. The sharing of this data will occur via peer-reviewed publications and conferences such as the annual meetings of the American Association for Dental, Oral and Craniofacial Research, the International Association for Dental Research and the annual meeting of the Academy of Dental Materials.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No