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OpenTrials
Completed

NCT Number: NCT07149376

To Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.

The objective of this clinical investigation is to assess the efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over an eight (8) week period.

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Key information

Conditions

Sensitivity, Tooth Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

FAR Oral and Systemic Health Consulting, Inc

Costa Mesa, California, 92627, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Sign an Informed Consent Form;
  • Male or female 18 to 70 years of age, inclusive;
  • Be in good general health as determined by the study investigators;
  • Available for the eight (8) weeks duration of the study;
  • Must present two (2) sensitive teeth which must meet ALL of the following criteria:
  • Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession;
  • Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10-50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA);
  • Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.

Exclusion criteria

  • Gross oral pathology, chronic disease, and/or history of allergies to any of the test products
  • Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
  • Advanced periodontal disease and/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 any other oral clinical study for the duration of this study
  • Self-reported pregnancy and/or currently breastfeeding;
  • Allergies to oral care products, personal care consumer products, and/or their ingredients
  • Medical condition which prohibits not eating/drinking for 4 hours

Treatment and study plan

TOMs of Maine Sensitive SLS Free Xtra Fresh

Device

Cover the entire length of bristled head with toothpaste. Brush your teeth twice daily (morning and evening) for one (1) minute each time.

For investigational use only by the study participant. Not for Sale.

Colgate Cavity Protection Toothpaste

Drug

Cover the entire length of bristled head with toothpaste. Brush your teeth twice daily (morning and evening) for (2) two minutes each time.

For investigational use only by the study participant.

Primary outcomes

  1. Tactile stimulation by the Yeaple Probe

    Time frame: baseline, 3 day, 4 weeks, 8 weeks

    Hypersensitivity defined by a response score in the range of 10-50 grams of force.

  2. Air blast stimulation

    Time frame: baseline, 3 day, 4 weeks, 8 weeks

    Jet of air delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F [± 3°F]) [hypersensitivity defined by a response 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

Clinical Investigation to Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 2, 2025
Registry last updated
Nov 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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