Oothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste in Reducing Dentinal Hypersensitivity

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

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity
• Intervention / Treatment: Drug: Toothpaste containing 8% Arginine; Drug: Colgate Cavity Protection Toothpaste

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 two test dentifrices.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 toothpaste; subjects will brush with assigned toothpaste morning & night	Drug: Toothpaste containing 8% Arginine; Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste
Active Comparator: Control toothpaste; subjects will brush with assigned toothpaste morning & night	Drug: Colgate Cavity Protection Toothpaste; Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Yiming LI, DDS, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Actual): November 4, 2025
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Amino Acids, Peptides, and Proteins; Amino Acids; Amino Acids, Basic; Amino Acids, Diamino; Amino Acids, Essential; Arginine
• Other Study ID Numbers: CRO-2025-06-SEN-TOM-ARG-YPZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes