Hypersensitivity Reduction Efficacy: 5% Potassium Nitrate Toothpaste Compared to Colgate Cavity Protection Toothpaste
Launched by COLGATE PALMOLIVE · May 1, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how effective a special toothpaste with 5% potassium nitrate is at reducing tooth sensitivity, compared to a regular cavity protection toothpaste. If you have sensitive teeth, especially those near the front of your mouth, this study may be for you. The trial will last for eight weeks and will involve testing how well each toothpaste works when you feel sensitivity from touch or cold air.
To be eligible for the study, participants should be between 18 and 70 years old and have at least two sensitive teeth that show signs of wear or gum recession. You should also be in good health and not have any known allergies to the products being tested. If you decide to participate, you'll need to commit to using the toothpaste provided during the study period and report back on your experiences with sensitivity. It's important to note that there are certain health conditions and medications that might prevent you from joining this trial, so it's best to talk to your doctor if you're interested.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male and female subjects, ages 18-70, inclusive.- Availability for the eight-week duration of the study.
- • Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
- • Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50 gms. of force.
- • Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
- • Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
- • Good general health with no known allergies to products being tested.
- • Use of a non-desensitizing dentifrice for three months prior to entry into the study.
- • Signed Informed Consent Form
- Exclusion Criteria:
- • Gross oral pathology, chronic disease, or history of allergy to test products.
- • Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- • Sensitive teeth with a mobility greater than one.
- • Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- • Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics.
- • Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
- • Current participation in any other clinical study.
- • Pregnant or lactating subjects.
- • Allergies to oral care products, personal care consumer products, or their ingredients.
- • Medical condition which prohibits not eating/drinking for 4 hours.
- • Use in the past of the three test dentifrices.
About Colgate Palmolive
Colgate-Palmolive is a global leader in oral care, personal care, home care, and pet nutrition, dedicated to enhancing the health and well-being of consumers worldwide. With a strong commitment to innovation and sustainability, the company conducts clinical trials to advance its product offerings, ensuring safety and efficacy while adhering to the highest ethical standards. Colgate-Palmolive's rigorous research initiatives are designed to generate scientific evidence that supports the development of effective solutions, ultimately promoting healthier lifestyles and contributing to the betterment of communities globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported