An interventional study of BLEACHING GEL A and 5% NF_TiO2 in Tooth Discoloration, Dentin Sensitivity and Patient Satisfaction, sponsored by University of Oklahoma. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.
This study's planned enrollment of 240 is above the median of 48 across 97 interventional studies indexed under Tooth Discoloration.
Browse Tooth Discoloration studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide will be applied for 50 minutes.
Device: BLEACHING GEL A
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
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF_TiO₂) applied for 50 minutes.
Device: 5% NF_TiO2 · Device: BLEACHING GEL B
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
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide applied for 50 minutes.
Device: BLEACHING GEL B
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.
Device: BLEACHING GEL B · Radiation: VISIBLE LIGHT IRRADIATION
Whiteness HP 35% applied for 30 minutes.
Device: Whiteness HP 35%
Whiteness HP 35% + 405 nm violet LED light applied for 30 minutes.
Radiation: VISIBLE LIGHT IRRADIATION · Device: Whiteness HP 35%
Whiteness HP AutoMixx 6% applied for 30 minutes.
Device: Whiteness HP Automixx 6%
Whiteness HP 6% + 405 nm violet LED light applied for 30 minutes.
Radiation: VISIBLE LIGHT IRRADIATION · Device: Whiteness HP Automixx 6%
Carbomer 940 hydrogel + 6% Hydrogen Peroxide
Bioactive nanoparticles
Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide
Low intensity visible light irradiation (405 nm)
Commercially available bleaching gel
Commercially available bleaching gel
Tooth Color - Delta E
Delta E ; This outcome measure is dimensionless and will be extracted from L\*, a\* and b\* values.
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)
Tooth Color - Delta E00
Delta E00; This outcome measure is dimensionless and will be extracted from L\*, a\* and b\* values.
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)
Tooth Color - WiD
WiD; This outcome measure is dimensionless and will be extracted from L\*, a\* and b\* values.
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)
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
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
Post-treatment questionnaire.
Time frame: at T4 (14 days after T3)
Plan to share: 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.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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