500 Participants NeededMy employer runs this trial

Calcium Sodium Phosphosilicate Toothpaste for Tooth Sensitivity

HR
Overseen ByHaleon Response Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a special toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS) can improve life for people with sensitive teeth. Participants will use this toothpaste twice daily for 24 weeks to test its effectiveness in reducing tooth sensitivity. Individuals with self-reported tooth sensitivity who can manage activities on a smart device may be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance daily comfort for those with sensitive teeth.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you regularly use pain relief medications more than 3 days a week, you may not be eligible to participate.

What prior data suggests that this toothpaste is safe for use?

Research has shown that Calcium Sodium Phosphosilicate (CSPS) toothpaste, like the one used in this trial, is generally safe. CSPS consists of elements naturally found in the body, which helps it integrate well with human systems. Studies have demonstrated its effectiveness in reducing tooth sensitivity, indicating its intended benefit.

However, using CSPS toothpaste might cause mild irritation to the skin and eyes if large amounts come into contact. Swallowing large amounts could also be harmful. These side effects are uncommon with normal use, such as brushing teeth.

Overall, research indicates that CSPS toothpaste carries a low risk of causing cancer, allergies, or other harmful effects. While minor risks exist, the toothpaste is considered safe for most people when used correctly.12345

Why are researchers excited about this trial?

Calcium Sodium Phosphosilicate (CSPS) toothpaste is unique because it directly targets tooth sensitivity by using a bioactive glass that releases calcium and phosphate ions. Unlike traditional desensitizing toothpastes that typically work by numbing the nerve endings in teeth, CSPS forms a protective hydroxyapatite layer on the tooth surface, effectively sealing exposed dentinal tubules. This innovative mechanism not only addresses immediate sensitivity relief but also promotes the natural remineralization of teeth, which could lead to longer-lasting protection. Researchers are excited about this treatment because it offers a dual benefit of sensitivity relief and tooth health enhancement, setting it apart from standard options.

What evidence suggests that Calcium Sodium Phosphosilicate Toothpaste might be an effective treatment for tooth sensitivity?

Research shows that toothpaste with 5% Calcium Sodium Phosphosilicate (CSPS) can help reduce tooth sensitivity. Studies have found that people using this toothpaste felt much less pain or discomfort in their teeth when exposed to certain triggers. For instance, one study discovered that users experienced less sensitivity after just two weeks. Another study showed that this toothpaste worked better than a placebo in reducing sensitivity. Overall, using CSPS toothpaste can improve oral health and comfort for those with sensitive teeth.56789

Who Is on the Research Team?

SV

Swathi Varanasi

Principal Investigator

Citruslabs

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have self-reported tooth sensitivity and can use smart devices. People can't join if their sensitivity is due to other dental issues, they wear dentures, recently had gum disease treatment, have active cavities or gum disease, severe pain conditions needing frequent pain meds, allergies to toothpaste ingredients, or serious acid reflux.

Inclusion Criteria

Participant who has provided consent indicating they have been informed of all pertinent aspects of the study
I have sensitive teeth.
I am between 18 and 65 years old.
See 1 more

Exclusion Criteria

My tooth sensitivity is not caused by other dental problems.
Participant with full or partial denture
I have been treated for gum disease in the past 6 months or am being treated now.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the test toothpaste twice daily for 24 weeks to manage dentin hypersensitivity

24 weeks
Decentralized study with self-reported assessments

Follow-up

Participants are monitored for changes in oral health-related quality of life using the DHEQ questionnaire

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Calcium Sodium Phosphosilicate (CSPS) Toothpaste

Trial Overview

The study tests a toothpaste with 5% calcium sodium phosphosilicate (CSPS) to see how well it relieves tooth sensitivity in real-world settings. Participants will use the toothpaste as part of their normal routine.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Test ToothpasteExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials
40
Recruited
6,000+

Citations

Effectiveness of a calcium sodium phosphosilicate containing ...

NovaMin® has shown to be effective in reducing dentine hypersensitivity when being used as an ingredient in toothpastes in concentration of 5% or 7.5% (Pradeep ...

Calcium sodium phosphosilicate toothpastes impact on ... - PMC

Desensitizing toothpastes are considered an effective treatment option for managing dentin hypersensitivity (DH). This review evaluated existing ...

Efficacy of an experimental toothpaste containing 5% calcium ...

Results: A total of 137 subjects were included in the efficacy analysis. The experimental 5% CSPS toothpaste demonstrated statistically significant reductions ...

A Clinical Study to Evaluate the Anti-Sensitivity Effect of a ...

The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate ...

Comparison of Clinical Efficacy of a Dentifrice Containing

All treatments showed a reduction in sensitivity. VAS scores compared to baseline following 2- and 6-weeks' use of the assigned toothpaste. • At all time points ...

MAY 1 0 2004 - accessdata.fda.gov

NovaMin ® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and 0). When exposed to ...

A clinical study of the effect of calcium sodium phosphosilicate ...

Calcium sodium phosphosilicate showed greater reduction in sensitivity compared to potassium nitrate at an earlier stage which is of high clinical value.

SAFETY DATA SHEET

SODIUM FLUORIDE (CAS 7681-49-4). 3 Not classifiable as to carcinogenicity to humans. TIN (II) FLUORIDE (CAS 7783-47-3). 3 Not classifiable as to carcinogenicity ...

Sensodyne® NUPRO® 5000 ppm Toothpaste with NovaMin

Emergency Overview: Small amounts may be irritating to skin and eyes while large amounts may be toxic if ingested. Long term exposure could lead ...