5% calcium sodium phosphosilicate (CSPS) toothpaste for dentin hypersensitivity relief

A Real-World Evidence Study Evaluating Oral Health Related Quality of Life With Use of a Calcium Sodium Phosphosilicate Anti-Sensitivity Dentifrice for Dentin Hypersensitivity Management

This study tests whether a commercially available 5% CSPS desensitizing toothpaste can improve oral-health-related quality of life for adults (18–65) with self-reported dentin sensitivity.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: HALEON (industry)
• Locations: 1 site (Las Vegas, Nevada)
• Trial ID: NCT07300540 on ClinicalTrials.gov

What this trial studies

This is a 24-week, decentralized, prospective, open-label, monadic study asking adults with self-reported dentin hypersensitivity to use a commercially available 5% CSPS toothpaste. Participants complete electronic questionnaires on their smart devices, including the validated Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), to track changes in oral health–related quality of life. The study plans to screen enough people to enroll about 500 participants to ensure approximately 400 evaluable completers. No comparator arm or blinding is used so outcomes reflect real-world product use.

Who should consider this trial

Good fit: Adults aged 18–65 with self-reported tooth sensitivity who can independently use smart devices and complete electronic study tasks are ideal candidates.

Not a fit: People whose sensitivity is due to other dental pathologies (for example active periodontal disease, recent periodontal treatment, dentures, or severe reflux-related erosion) or who need clinical dental intervention are less likely to benefit from this toothpaste alone.

Why it matters

Potential benefit: If successful, regular use of the 5% CSPS toothpaste could reduce dentin sensitivity symptoms and improve day-to-day oral health–related quality of life.

How similar studies have performed: Previous clinical trials of CSPS (NovaMin) formulations have shown reductions in dentin hypersensitivity, so this approach has supportive evidence though this study focuses on real-world quality-of-life outcomes.

Eligibility criteria

Inclusion Criteria:

* Participant who has provided consent indicating they have been informed of all pertinent aspects of the study.
* All genders who, at the time of screening, are aged 18 to 65.
* Participant who is able to independently complete all activities on their smart devices
* Participant who has tooth sensitivity (self-reported symptoms).

Exclusion Criteria:

* Participants whose tooth sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:

  1. Participant who has been/is on multiple prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux.
  2. Participant with full or partial denture.
  3. Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease.
  4. Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
  5. Participants who have been informed by a DHCP that they have active caries.
  6. Participant with any chronic and/or severe painful health condition which lead to regular use of pain relief medications (more than 3 days a week).
* Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

Where this trial is running

Las Vegas, Nevada

• Citruslabs (Virtual Site) — Las Vegas, Nevada, United States (RECRUITING)

Study contacts

• Principal investigator: Swathi Varanasi — Citruslabs
• Study coordinator: Haleon Response Center

Conditions: Dentin Sensitivity