Stannous Fluoride + Potassium Nitrate Dentifrice for Tooth Sensitivity

Recruiting at 2 trial locations

Overseen By Haleon Response Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: HALEON

Must not be taking: Antihypersensitivity products, Antibiotics

Disqualifiers: Pregnancy, Breastfeeding, Recent dental procedures, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

850 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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

Participant has a minimum of 2 non-adjacent teeth with exposed dentin due to facial/cervical erosion, abrasion or gingival recession, and clinically confirmed dentin hypersensitivity to tactile and evaporative (air) stimuli at Screening and Baseline

Provision of signed and dated informed consent document (and assent document, if appropriate)

I am biologically male or female.

Exclusion Criteria

Participant with known or suspected intolerance or hypersensitivity to any of the study products, any of their stated ingredients or closely related compounds

Participant is participating in, or has participated in, other studies involving an Investigational Product within 30 days of Screening or plans to participate in other studies during this study

Participant has participated in a tooth sensitivity study within 8 weeks of Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants are assessed for dentin hypersensitivity and randomized to treatment groups

1 week

1 visit (in-person)

Treatment

Participants use assigned dentifrice twice daily for 8 weeks

8 weeks

7 visits (in-person)

Follow-up

Participants are monitored for changes in sensitivity scores and tactile thresholds

4 weeks

2 visits (in-person)

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?

Group I: Test Dentifrice Experimental Treatment 1 Intervention

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.

Group II: Reference Dentifrice 1 Active Control 1 Intervention

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.

Group III: Reference Dentifrice 2 Active Control 1 Intervention

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.

Group IV: Reference Dentifrice 3 Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11686824/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07215767

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 ...

3. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/10.1002/JPER.24-0688?af=R

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1532338202700596

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 ...

5. nature.com nature.com/articles/s41598-023-31616-6

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 ...

6. dentalcare.com dentalcare.com/en-us/ce-courses/ce200/stannous-fluoride

Stannous Fluoride & Sensitivity - CE Course Twice daily brushing with the stabilized stannous fluoride dentifrice provides superior dentinal hypersensitivity improvement versus a marketed sodium fluoride ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10965716/

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.

8. go.drugbank.com go.drugbank.com/conditions/DBCOND0046413

Dentine Hypersensitivity (DBCOND0046413) Associated Data ; Potassium nitrate. A medication used to cauterize small wounds, remove granulation tissue, warts, and verrucae, and treat tooth sensitivity.

9. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/pdf/10.1002/JPER.24-0688

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 ...