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Clinical Trial NCT07257042 for Hypersensitivity is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Oothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste in Reducing Dentinal Hypersensitivity

Active, not recruiting
Clinical Trial NCT07257042 is designed to study Treatment for Hypersensitivity. It is a Phase 3 interventional trial that is active, not recruiting, having started on 14 July 2025, with plans to enroll 80 participants. Led by Colgate Palmolive, it is expected to complete by 1 November 2025. The latest data from ClinicalTrials.gov was last updated on 2 December 2025.
Brief Summary
The objective of this study is to assess clinical efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) to provide dental hypersensitivity relief (tactile and air blast) in comparison to Colgate Cavity Protection Toothpaste (Colgate-Palmolive Company, New York, NY, USA) over an eight-week period.
Official Title

The Clinical Investigation of a Toothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste in Reducing Dentinal Hypersensitivity - an Eight-week Clinical Study in the US

Conditions
Hypersensitivity
Other Study IDs
  • CRO-2025-06-SEN-TOM-ARG-YPZ
NCT ID Number
NCT07257042
Start Date (Actual)
2025-07-14
Last Update Posted
2025-12-02
Completion Date (Estimated)
2025-11
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTest 1 toothpaste
subjects will brush with assigned toothpaste morning \& night
Toothpaste Containing 8% Arginine
Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste
Active ComparatorControl toothpaste
subjects will brush with assigned toothpaste morning \& night
Colgate Cavity Protection Toothpaste
Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Tactile stimulation with a Yeaple Probe. treatment Tactile and Air Blast Hypersensitivity scores. The mean Tactile and Air Blast Hypersensitivity will be computed and summarized
Sensitivity will be defined by a score in the range of 10-50 gms. of force
Baseline 4 week & 8 week
Schiff Cold Air Sensitivity Scale
Sensitivity will be defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale
Baseline 4 week & 8 week
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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 two test dentifrices.
Colgate Palmolive logoColgate Palmolive
No contact data.
1 Study Locations in 1 Countries

California

Loma Linda University, Loma Linda, California, 92350, United States