Efficacy and Safety Assessment of Experimental Bleaching Agents

Starting soon · Not applicable

Conditions studied: Tooth Discoloration, Dentin Sensitivity, Patient Satisfaction

In brief

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.

Key facts

Study ID

NCT06802614

Run by

University of Oklahoma

People needed

240

Starts

2025-03-01

Expected to finish

2025-09-30

Last updated by the study team

2025-01-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The University of Oklahoma Health Sciences Center College of Dentistry — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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