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Efficacy and Safety Assessment of Experimental Bleaching Agents

NCT ID: NCT06802614

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Discoloration Dentin Sensitivity Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

BLEACHING GEL A

Intervention Type DEVICE

Carbomer 940 hydrogel + 6% Hydrogen Peroxide

5% NF_TiO2

Intervention Type DEVICE

Bioactive nanoparticles

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.

Group Type EXPERIMENTAL

BLEACHING GEL A

Intervention Type DEVICE

Carbomer 940 hydrogel + 6% Hydrogen Peroxide

5% NF_TiO2

Intervention Type DEVICE

Bioactive nanoparticles

VISIBLE LIGHT IRRADIATION

Intervention Type RADIATION

Low intensity visible light irradiation (405 nm)

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.

Group Type EXPERIMENTAL

BLEACHING GEL A

Intervention Type DEVICE

Carbomer 940 hydrogel + 6% Hydrogen Peroxide

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.

Group Type EXPERIMENTAL

BLEACHING GEL A

Intervention Type DEVICE

Carbomer 940 hydrogel + 6% Hydrogen Peroxide

VISIBLE LIGHT IRRADIATION

Intervention Type RADIATION

Low intensity visible light irradiation (405 nm)

5. Gel B with nanoparticles, no light.

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

Group Type EXPERIMENTAL

5% NF_TiO2

Intervention Type DEVICE

Bioactive nanoparticles

BLEACHING GEL B

Intervention Type DEVICE

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide

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.

Group Type EXPERIMENTAL

5% NF_TiO2

Intervention Type DEVICE

Bioactive nanoparticles

BLEACHING GEL B

Intervention Type DEVICE

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide

VISIBLE LIGHT IRRADIATION

Intervention Type RADIATION

Low intensity visible light irradiation (405 nm)

7. Gel B without nanoparticles, no light.

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

Group Type EXPERIMENTAL

BLEACHING GEL B

Intervention Type DEVICE

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide

8. Gel B without nanoparticles, with light.

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

Group Type EXPERIMENTAL

BLEACHING GEL B

Intervention Type DEVICE

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide

VISIBLE LIGHT IRRADIATION

Intervention Type RADIATION

Low intensity visible light irradiation (405 nm)

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

Whiteness HP 35% applied for 30 minutes.

Group Type ACTIVE_COMPARATOR

Whiteness HP 35%

Intervention Type DEVICE

Commercially available bleaching gel

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

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

Group Type ACTIVE_COMPARATOR

VISIBLE LIGHT IRRADIATION

Intervention Type RADIATION

Low intensity visible light irradiation (405 nm)

Whiteness HP 35%

Intervention Type DEVICE

Commercially available bleaching gel

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

Whiteness HP AutoMixx 6% applied for 30 minutes.

Group Type ACTIVE_COMPARATOR

Whiteness HP Automixx 6%

Intervention Type DEVICE

Commercially available bleaching gel

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

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

Group Type ACTIVE_COMPARATOR

VISIBLE LIGHT IRRADIATION

Intervention Type RADIATION

Low intensity visible light irradiation (405 nm)

Whiteness HP Automixx 6%

Intervention Type DEVICE

Commercially available bleaching gel

Interventions

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BLEACHING GEL A

Carbomer 940 hydrogel + 6% Hydrogen Peroxide

Intervention Type DEVICE

5% NF_TiO2

Bioactive nanoparticles

Intervention Type DEVICE

BLEACHING GEL B

Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide

Intervention Type DEVICE

VISIBLE LIGHT IRRADIATION

Low intensity visible light irradiation (405 nm)

Intervention Type RADIATION

Whiteness HP 35%

Commercially available bleaching gel

Intervention Type DEVICE

Whiteness HP Automixx 6%

Commercially available bleaching gel

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

The University of Oklahoma Health Sciences Center College of Dentistry

Locations

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The University of Oklahoma Health Sciences Center College of Dentistry

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Central Contacts

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

Role: CONTACT

[email protected]
(405)271-6545 ext. 48646

Facility Contacts

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Fernando L Esteban Florez, DDS, MS, PhD

Role: primary

[email protected]
405-271-6545 ext. 48646

References

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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.

Reference Type BACKGROUND
PMID: 36080033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37369816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38963521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39320486 (View on PubMed)

Other Identifiers

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OUCOD001

Identifier Type: -

Identifier Source: org_study_id

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