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Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice
Led by HALEON · Updated on 2026-02-05
850
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new dentifrice combining stannous fluoride and potassium nitrate for people aged 12 to 65 with dentin hypersensitivity. The study aims to show if this new product works better at reducing tooth sensitivity compared to dentifrices containing only stannous fluoride, only potassium nitrate, or a placebo. This Phase III trial involves healthy participants who have had tooth sensitivity for more than six months but less than ten years. Participants will be randomly assigned to one of four groups to use a specific dentifrice twice daily for about 8 weeks. Each participant will brush their teeth thoroughly for at least one minute with a 1-inch strip of the assigned dentifrice, making sure to focus on sensitive areas. The four products tested include the investigational dentifrice combining stannous fluoride and potassium nitrate, two active comparators containing either stannous fluoride or potassium nitrate alone, and a placebo dentifrice. During the study, participants will attend 7 visits over 8 weeks, including screening, baseline, and follow-ups at 3 days, 1 week, 2 weeks, 4 weeks, and 8 weeks. At these visits, researchers will assess dentin hypersensitivity using clinical tests like the Schiff sensitivity score and tactile threshold measurements. Safety and oral health will also be monitored regularly. The main outcomes will focus on changes in tooth sensitivity after 8 weeks of using the assigned dentifrice.
CONDITIONS
Brief Title
Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent (and assent if appropriate)
- Biologically male or female
- Aged 12 to 65 years inclusive at consent
- Good general, oral, and mental health without significant abnormalities
- History of tooth sensitivity lasting more than six months but less than 10 years
- At least 2 non-adjacent teeth with exposed dentin and confirmed dentin hypersensitivity to tactile and air stimuli
You will not qualify if you...
- Pregnant or intending to become pregnant women at screening or baseline
- Breastfeeding women
- Known or suspected intolerance or allergy to study products or ingredients
- Participation in other investigational studies within 30 days before screening or during this study
- Participation in a tooth sensitivity study within 8 weeks before screening
- Current or recent use (within 8 weeks) of oral care products for sensitive teeth or antihypersensitivity treatments
- Use of medications that may affect tooth sensitivity perception
- Professional tooth de-sensitising treatment within 8 weeks before screening
- Tooth bleaching procedure within 8 weeks before screening
- Dental cleaning (prophylaxis) within 4 weeks before screening
- Evidence of poor oral hygiene or need for extensive dental therapy
- Active dental caries or treatment for decay within 12 months before screening
- High risk of dental caries as judged by dental professional
- Specific dentition exclusions for "Test Teeth"
- Antibiotic use within 2 weeks before screening or baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants use their assigned dentifrice by brushing their teeth twice a day for approximately 8 weeks, focusing on sensitive areas. Clinical assessments of dentin hypersensitivity occur at multiple timepoints to evaluate effectiveness.
7 study visits including Baseline, Day 4, Week 1, Week 2, Week 4, and Week 8
Trial Site Locations
Total: 3 locations
1
All Sum Research Limited
Melbourne, Florida, United States, 32935
Actively Recruiting
2
Salus Research, Inc.
Fort Wayne, Indiana, United States, 46825
Actively Recruiting
3
Silverstone Research
Las Vegas, Nevada, United States, 89146
Actively Recruiting
Research Team
H
Haleon Response Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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