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Completed

NCT Number: NCT07257042

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toothpaste containing 8% Arginine

Drug

Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste

Colgate Cavity Protection Toothpaste

Drug

Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste

Primary outcomes

  1. 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

    Time frame: Baseline 4 week & 8 week

    Sensitivity will be defined by a score in the range of 10-50 gms. of force

  2. Schiff Cold Air Sensitivity Scale

    Time frame: Baseline 4 week & 8 week

    Sensitivity will be defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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