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Efficacy and Safety Assessment of Experimental Bleaching Agents

ConditionsTooth DiscolorationDentin SensitivityPatient Satisfaction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18-65 years old.

Healthy periodontal tissues.

Willingness to participate and follow the post-treatment protocols.

Ability to provide informed consent.

Disqualifiers

Pregnant or breastfeeding women.

Teeth with restorations.

History of dentin hypersensitivity.

Active caries, periodontal disease or endodontically treated teeth.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BLEACHING GEL A

    Device

    Carbomer 940 hydrogel + 6% Hydrogen Peroxide

  • 5% NF_TiO2

    Device

    Bioactive nanoparticles

  • BLEACHING GEL B

    Device

    Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide

  • VISIBLE LIGHT IRRADIATION

    Radiation

    Low intensity visible light irradiation (405 nm)

  • Whiteness HP 35%

    Device

    Commercially available bleaching gel

  • Whiteness HP Automixx 6%

    Device

    Commercially available bleaching gel

Treatment groups

240 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: 1. Gel A with nanoparticles, no light.Experimental treatment 2 interventions
Group B: 2. Gel A with nanoparticles, with light.Experimental treatment 3 interventions
Group C: 3. Gel A without nanoparticles, no light.Experimental treatment 1 intervention
Group D: 4. Gel A without nanoparticles, with light.Experimental treatment 2 interventions
Group E: 5. Gel B with nanoparticles, no light.Experimental treatment 2 interventions
Group F: 6. Gel B with nanoparticles, with light.Experimental treatment 3 interventions
Group G: 7. Gel B without nanoparticles, no light.Experimental treatment 1 intervention
Group H: 8. Gel B without nanoparticles, with light.Experimental treatment 2 interventions
Group I: 9. Whiteness HP 35% no light (control).Active comparator 1 intervention
Group J: 10. Whiteness HP 35% with light (control).Active comparator 2 interventions
Group K: 11. Whiteness HP AutoMixx 6% no light (control)Active comparator 1 intervention
Group L: 12. Whiteness HP AutoMixx 6% with light (control)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)

Secondary outcomes

1

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)
2

Patient Satisfaction

Post-treatment questionnaire.

Time frame
at T4 (14 days after T3)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: