Tooth DiscolorationNCT06802614
Efficacy and Safety Assessment of Experimental Bleaching Agents
A study testing BLEACHING GEL A, 5% NF_TiO2 and BLEACHING GEL B in people with Tooth Discoloration and Dentin Sensitivity, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Dentin Sensitivity, Patient Satisfaction
- What is being tested?
- BLEACHING GEL A, 5% NF_TiO2 and BLEACHING GEL B
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fernando L Esteban Florez, D.D.S., M.S., Ph.D. contact
United States1 site
The University of Oklahoma Health Sciences Center College of Dentistry
Oklahoma City, Oklahoma, 73117
Fernando L Esteban Florez, DDS, MS, PhD, 405-271-6545 ext. 48646, festeban@ouhsc.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- BLEACHING GEL A, 5% NF_TiO2, BLEACHING GEL B, VISIBLE LIGHT IRRADIATION, Whiteness HP 35%
- Keywords
- Tooth Whitenining, Dental Bleaching, Hydrogen Peroxide, Titanium Dioxide Nanoparticles
- Medical subject headings
- Tooth Discoloration, Dentin Sensitivity, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLEACHING GEL ADevice
Carbomer 940 hydrogel + 6% Hydrogen Peroxide
5% NF_TiO2Device
Bioactive nanoparticles
BLEACHING GEL BDevice
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide
VISIBLE LIGHT IRRADIATIONRadiation
Low intensity visible light irradiation (405 nm)
Whiteness HP 35%Device
Commercially available bleaching gel
Whiteness HP Automixx 6%Device
Commercially available bleaching gel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: BLEACHING GEL B; Radiation: VISIBLE LIGHT IRRADIATION |
| 9. Whiteness HP 35% no light (control). | Active comparator | Whiteness HP 35% applied for 30 minutes. Receives: 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. Receives: 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. Receives: 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. Receives: Radiation: VISIBLE LIGHT IRRADIATION; Device: Whiteness HP Automixx 6% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth Color - Delta E
Delta E ; This outcome measure is dimensionless and will be extracted from L*, a* and b* values.
Measured: 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.
Measured: 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.
Measured: 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
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
Measured: 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.
Measured: at T4 (14 days after T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando L Esteban Florez, D.D.S., M.S., Ph.D., Principal investigator, The University of Oklahoma Health Sciences Center College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802614
- Sponsor's protocol ID
- OUCOD001
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 36080033Matos 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.
PubMed 37369816Kury 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.
PubMed 38963521Kury 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.
PubMed 39320486
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06802614
- Acronym / sponsor ID
- OUCOD001
- Keywords
- Tooth Whitenining, Dental Bleaching, Hydrogen Peroxide, Titanium Dioxide Nanoparticles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1. Gel A with nanoparticles, no light. | Experimental | Device: BLEACHING GEL A, Device: 5% NF_TiO2An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) will be applied for 50 minutes. |
| 2. Gel A with nanoparticles, with light. | Experimental | Device: BLEACHING GEL A, Device: 5% NF_TiO2, Radiation: VISIBLE LIGHT IRRADIATIONAn 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. |
| 3. Gel A without nanoparticles, no light. | Experimental | Device: BLEACHING GEL AAn experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide will be applied for 50 minutes. |
| 4. Gel A without nanoparticles, with light. | Experimental | Device: BLEACHING GEL A, Radiation: VISIBLE LIGHT IRRADIATIONAn experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes. |
| 5. Gel B with nanoparticles, no light. | Experimental | Device: 5% NF_TiO2, Device: BLEACHING GEL BHyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) applied for 50 minutes. |
| 6. Gel B with nanoparticles, with light. | Experimental | Device: 5% NF_TiO2, Device: BLEACHING GEL B, Radiation: VISIBLE LIGHT IRRADIATIONHyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) + 405 nm violet LED light applied for 50 minutes. |
| 7. Gel B without nanoparticles, no light. | Experimental | Device: BLEACHING GEL BHyaluronic Acid hydrogel + 6% Hydrogen Peroxide applied for 50 minutes. |
| 8. Gel B without nanoparticles, with light. | Experimental | Device: BLEACHING GEL B, Radiation: VISIBLE LIGHT IRRADIATIONHyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes. |
| 9. Whiteness HP 35% no light (control). | Active comparator | Device: Whiteness HP 35%Whiteness HP 35% applied for 30 minutes. |
| 10. Whiteness HP 35% with light (control). | Active comparator | Radiation: VISIBLE LIGHT IRRADIATION, Device: Whiteness HP 35%Whiteness HP 35% + 405 nm violet LED light applied for 30 minutes. |
| 11. Whiteness HP AutoMixx 6% no light (control) | Active comparator | Device: Whiteness HP Automixx 6%Whiteness HP AutoMixx 6% applied for 30 minutes. |
| 12. Whiteness HP AutoMixx 6% with light (control) | Active comparator | Radiation: VISIBLE LIGHT IRRADIATION, Device: Whiteness HP Automixx 6%Whiteness HP 6% + 405 nm violet LED light applied for 30 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLEACHING GEL ACarbomer 940 hydrogel + 6% Hydrogen Peroxide | Device | 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_TiO2Bioactive nanoparticles | Device | 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 BHyaluronic Acid hydrogel + 6% Hydrogen Peroxide | Device | 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 IRRADIATIONLow intensity visible light irradiation (405 nm) | Radiation | 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%Commercially available bleaching gel | Device | 10. Whiteness HP 35% with light (control)., 9. Whiteness HP 35% no light (control). |
| Whiteness HP Automixx 6%Commercially available bleaching gel | Device | 11. Whiteness HP AutoMixx 6% no light (control), 12. Whiteness HP AutoMixx 6% with light (control) |
Primary outcome
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.
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.
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.
2 secondary outcomes
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)
Patient Satisfaction
Time frame: at T4 (14 days after T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 36080033Kury 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.
- Background: PubMed 37369816Matos 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.
- Background: PubMed 38963521Kury 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.
- Background: PubMed 39320486Kury 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando L Esteban Florez, D.D.S., M.S., Ph.D. contact
Fernando L Esteban Florez, D.D.S., M.S., Ph.D. principal investigator
The University of Oklahoma Health Sciences Center College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLEACHING GEL A, 5% NF_TiO2 and BLEACHING GEL B in people with Tooth Discoloration and Dentin Sensitivity, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando L Esteban Florez, D.D.S., M.S., Ph.D. ((405)271-6545 ext. 48646, fernando-esteban-florez@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802614, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.