Efficacy and Safety Assessment of Experimental Bleaching Agents

January 24, 2025 updated by: University of Oklahoma

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tooth Color - Delta E
Time Frame: At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
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
Time Frame: At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
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
Time Frame: At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tooth sensitivity
Time Frame: At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
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
Time Frame: at T4 (14 days after T3)
Post-treatment questionnaire.
at T4 (14 days after T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oklahoma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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