Skip to main content
OpenTrials
Completed

NCT Number: NCT06244290

Dentinal Hypersensitivity Reduction

The objective of this clinical study is to assess the efficacy of a dentifrice containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially-available potassium-based toothpaste (Sensodyne Extra Whitening Toothpaste, GlaxoSmithKline Co., UK) and a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over a seven (7) day period.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mesa Dental Centre

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 seven (7) days 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

Colgate SNF

Drug

toothpaste

Sensodyne Extra Whitening

Drug

toothpaste

Colgate Fluoride (CDC)

Drug

toothpaste

Primary outcomes

  1. Tactile dentin hypersensitivity

    Time frame: Baseline, 1-Day, 3-Days and 7-Days

    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)

  2. Air blast dentin hypersensitivity

    Time frame: Baseline, 1-Day, 3-Days and 7-Days

    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.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Study to Assess the Efficacy of a Dentifrice Containing Stannous Fluoride as Compared to a Commercially-available Potassium-based Toothpaste and a Regular Fluoride Toothpaste on the Reduction of Dentinal Hypersensitivity.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2024
Registry last updated
Mar 18, 2026

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.

Published trials that share one or more normalized conditions with this study.