Clinical trial NCT06802614: Efficacy and Safety Assessment of Experimental Bleaching Agents
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Discoloration
Dentin Sensitivity
Patient Satisfaction
Keywords: Tooth Whitenining
Dental Bleaching
Hydrogen Peroxide
Titanium Dioxide Nanoparticles
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tooth Color - Delta E
timeFrame: At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
measure: Tooth Color - Delta E00
timeFrame: At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
measure: Tooth Color - WiD
timeFrame: 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:
measure: Tooth sensitivity
timeFrame: At baseline (T0), after each clinical session (T1, T2 and T3; 7 days interval between sessions) and at T4 (14 days after T3)
measure: Patient Satisfaction
timeFrame: at T4 (14 days after T3)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center College of Dentistry
state: Oklahoma
Study officials:
affiliation: The University of Oklahoma Health Sciences Center College of Dentistry
name: Fernando L Esteban Florez, D.D.S., M.S., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.