Stannous Fluoride + Potassium Nitrate Dentifrice for Tooth Sensitivity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new toothpaste combining stannous fluoride and potassium nitrate reduces tooth sensitivity more effectively than toothpastes containing only one of these ingredients or a placebo (a substance with no therapeutic effect). Participants will brush their teeth twice daily for 8 weeks using one of these types of toothpaste. This trial suits individuals who have experienced tooth sensitivity for more than six months but less than ten years and have specific teeth with exposed dentin (the sensitive layer beneath the enamel) due to erosion or gum recession. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you take daily medications that might affect your perception of tooth sensitivity, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that stannous fluoride and potassium nitrate are safe for treating tooth sensitivity. Research shows that stannous fluoride in toothpaste is well-tolerated and reduces sensitivity without major side effects. Similarly, potassium nitrate is commonly used for tooth sensitivity and is generally safe, with few reports of negative effects. Both ingredients have been used in dental products for years, indicating safety for most people. For specific concerns, discussing them with a dentist or healthcare provider might be helpful.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the Stannous Fluoride + Potassium Nitrate Dentifrice treatment for tooth sensitivity because it combines two powerful ingredients that address the condition in different ways. Stannous fluoride helps to strengthen and protect tooth enamel, potentially reducing sensitivity by blocking tiny pathways through the teeth that lead to nerves. Meanwhile, potassium nitrate works by calming the nerves inside the teeth, providing relief from sensitivity. This dual-action approach could offer a more comprehensive solution compared to other options that typically focus on just one mechanism.
What evidence suggests that this trial's treatments could be effective for tooth sensitivity?
Research has shown that the new toothpaste with stannous fluoride and potassium nitrate, which participants in this trial may receive as the Test Dentifrice, effectively reduces tooth sensitivity. Studies indicate it outperforms toothpaste containing only stannous fluoride or only potassium nitrate. One study found it significantly improved sensitivity compared to other options. Users reported less tooth pain with regular use. This suggests that combining these ingredients can help ease discomfort from sensitive teeth.16789
Who Is on the Research Team?
Pejmon Amini
Principal Investigator
Silverstone Research
Jeffery L Milleman
Principal Investigator
Salus Research, Inc
John T Gallob
Principal Investigator
All Sum Research
Are You a Good Fit for This Trial?
This trial is for individuals with tooth sensitivity or hypersensitive dentin. Participants should be seeking treatment for these conditions and willing to use the test products as directed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants are assessed for dentin hypersensitivity and randomized to treatment groups
Treatment
Participants use assigned dentifrice twice daily for 8 weeks
Follow-up
Participants are monitored for changes in sensitivity scores and tactile thresholds
What Are the Treatments Tested in This Trial?
Interventions
- Stannous fluoride and Potassium nitrate Dentifrice
Trial Overview
The study tests a new toothpaste that combines stannous fluoride and potassium nitrate against three other types: one with just stannous fluoride, one with just potassium nitrate, and a placebo without active ingredients. Usage is twice daily for 8 weeks.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Participants will be instructed to dose the toothbrush head with the Test Dentifrice (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth.
Participants will be instructed to dose the toothbrush head with Reference Dentifrice 1 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth.
Participants will be instructed to dose the toothbrush head with Reference Dentifrice 2 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth.
Participants will be instructed to dose the toothbrush head with Reference Dentifrice 3 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth.
Find a Clinic Near You
Who Is Running the Clinical Trial?
HALEON
Lead Sponsor
Citations
Comparative investigations of the desensitising efficacy ...
Conclusions: These studies demonstrate that the new dentifrice, containing potassium nitrate, stannous fluoride and sodium fluoride is significantly better ...
NCT07215767 | Clinical Study to Investigate the ...
The aim of this clinical study is to demonstrate the superior antihypersensitivity efficacy of a novel stannous fluoride (SnF2) and ...
Randomized clinical trial evaluating kinetic benefits of ...
Stannous fluoride toothpaste had greater improvements in tactile sensitivity versus potassium nitrate toothpaste at Day 3. Overall, stannous ...
A dentifrice containing potassium nitrate, stannous fluoride, ...
Conclusions. The test dentifrice containing potassium nitrate, stannous fluoride, and sodium fluoride is significantly better at reducing sensitivity than ...
A randomized clinical trial for comparing the efficacy of ...
Dentifrices containing 2% strontium chloride and 5% potassium nitrate are efficacious in instantly reducing DH after topical application and ...
Stannous Fluoride & Sensitivity - CE Course
Twice daily brushing with the stabilized stannous fluoride dentifrice provides superior dentinal hypersensitivity improvement versus a marketed sodium fluoride ...
Efficacy of a stannous fluoride dentifrice for relieving ...
Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial.
Dentine Hypersensitivity (DBCOND0046413)
Associated Data ; Potassium nitrate. A medication used to cauterize small wounds, remove granulation tissue, warts, and verrucae, and treat tooth sensitivity.
Randomized clinical trial evaluating kinetic benefits of ...
Stannous fluoride toothpaste had greater improvements in tactile sensitivity versus potassium nitrate tooth- paste at Day 3. Overall, stannous ...
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