Efficacy and Safety Assessment of Experimental Bleaching Agents

NCT06802614 | Not Yet Recruiting

• 1 other identifier: OUCOD001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Discoloration; Dentin Sensitivity; Patient Satisfaction

Keywords

Tooth Whitenining; Dental Bleaching; Hydrogen Peroxide; Titanium Dioxide Nanoparticles

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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)

• Patient Satisfaction

  at T4 (14 days after T3)

Study Arms (12)

1. Gel A with nanoparticles, no light.

EXPERIMENTAL

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; Device: 5% NF_TiO2

2. Gel A with nanoparticles, with light.

EXPERIMENTAL

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; Device: 5% NF_TiO2; Radiation: VISIBLE LIGHT IRRADIATION

3. Gel A without nanoparticles, no light.

EXPERIMENTAL

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

Device: BLEACHING GEL A

4. Gel A without nanoparticles, with light.

EXPERIMENTAL

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; Radiation: VISIBLE LIGHT IRRADIATION

5. Gel B with nanoparticles, no light.

EXPERIMENTAL

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\_TiO₂) applied for 50 minutes.

Device: 5% NF_TiO2; Device: BLEACHING GEL B

6. Gel B with nanoparticles, with light.

EXPERIMENTAL

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\_TiO₂) + 405 nm violet LED light applied for 50 minutes.

Device: 5% NF_TiO2; Device: BLEACHING GEL B; Radiation: VISIBLE LIGHT IRRADIATION

7. Gel B without nanoparticles, no light.

EXPERIMENTAL

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

Device: BLEACHING GEL B

8. Gel B without nanoparticles, with light.

EXPERIMENTAL

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

Device: BLEACHING GEL B; Radiation: VISIBLE LIGHT IRRADIATION

9. Whiteness HP 35% no light (control).

ACTIVE COMPARATOR

Whiteness HP 35% applied for 30 minutes.

Device: Whiteness HP 35%

10. Whiteness HP 35% with light (control).

ACTIVE COMPARATOR

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

Radiation: VISIBLE LIGHT IRRADIATION; Device: Whiteness HP 35%

11. Whiteness HP AutoMixx 6% no light (control)

ACTIVE COMPARATOR

Whiteness HP AutoMixx 6% applied for 30 minutes.

Device: Whiteness HP Automixx 6%

12. Whiteness HP AutoMixx 6% with light (control)

ACTIVE COMPARATOR

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

Radiation: VISIBLE LIGHT IRRADIATION; Device: Whiteness HP Automixx 6%

Interventions

BLEACHING GEL A DEVICE

Carbomer 940 hydrogel + 6% Hydrogen Peroxide

1. Gel A with nanoparticles, no light.; 2. Gel A with nanoparticles, with light.; 3. Gel A without nanoparticles, no light.; 4. Gel A without nanoparticles, with light.

5% NF_TiO2 DEVICE

Bioactive nanoparticles

1. Gel A with nanoparticles, no light.; 2. Gel A with nanoparticles, with light.; 5. Gel B with nanoparticles, no light.; 6. Gel B with nanoparticles, with light.

BLEACHING GEL B DEVICE

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide

5. Gel B with nanoparticles, no light.; 6. Gel B with nanoparticles, with light.; 7. Gel B without nanoparticles, no light.; 8. Gel B without nanoparticles, with light.

VISIBLE LIGHT IRRADIATION RADIATION

Low intensity visible light irradiation (405 nm)

10. Whiteness HP 35% with light (control).; 12. Whiteness HP AutoMixx 6% with light (control); 2. Gel A with nanoparticles, with light.; 4. Gel A without nanoparticles, with light.; 6. Gel B with nanoparticles, with light.; 8. Gel B without nanoparticles, with light.

Whiteness HP 35% DEVICE

Commercially available bleaching gel

10. Whiteness HP 35% with light (control).; 9. Whiteness HP 35% no light (control).

Whiteness HP Automixx 6% DEVICE

Commercially available bleaching gel

11. Whiteness HP AutoMixx 6% no light (control); 12. Whiteness HP AutoMixx 6% with light (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

The University of Oklahoma Health Sciences Center College of Dentistry

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (4)

• 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.

  PMID: 36080033 BACKGROUND

• 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.

  PMID: 37369816 BACKGROUND

• 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.

  PMID: 38963521 BACKGROUND

• 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.

  PMID: 39320486 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration; Dentin Sensitivity; Patient Satisfaction

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

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

  The University of Oklahoma Health Sciences Center College of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

(405)271-6545; fernando-esteban-florez@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a randomized, parallel-arm clinical trial that compares the efficacy of the two experimental bleaching gels, with and without nanoparticles, versus two commercial products that serve as the control groups.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 31, 2025
• Study Start: March 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)