Dentinal Hypersensitivity Reduction

March 16, 2026 updated by: Colgate Palmolive

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Costa Mesa, California, United States, 92627
        • Mesa Dental Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Drug: Colgate SNF
toothpaste
Active Comparator: Group II
Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Drug: Sensodyne Extra Whitening
toothpaste
Placebo Comparator: Group III
Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush
Drug: Colgate Fluoride (CDC)
toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 1-Day, 3-Days and 7-Days
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.
Baseline, 1-Day, 3-Days and 7-Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Farid Ayad, DMD, MSD, Mesa Dental Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2020

Primary Completion (Actual)

October 21, 2020

Study Completion (Actual)

October 21, 2020

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2020-05-SEN-SNF-CA-BGS

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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