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Completed

NCT Number: NCT07738198

Dentin Hypersensitivity Reduction Efficacy Clinical

The objective of this study is to assess clinical efficacy of a toothpaste containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) to provide dental hypersensitivity relief (tactile and air blast) in comparison to commercially available potassium-based desensitizing toothpaste (Senodyne Extra Whitening Toothpaste, GasoSmithKline Co., UK) and commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) over a seven day study 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

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

  • Must be male or female 18 to 70 years of age
  • Must give written informed consent
  • Must be in good general health as determined by the study investigators
  • Must be available for the seven day duration of the study
  • Must have 2 hypersensitive teeth which must meet ALL of the following inclusion criteria:

Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion 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

  • Allergies to oral care products, personal care consumer products, or their ingredients.
  • Use of a desensitizing oral care product or recipient of desensitizing treatment within three months prior to start of the study.
  • Gross oral pathology, 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 any other oral clinical studies for the duration of this study
  • Full or partial removable oral prostheses
  • Pregnant or lactating (breast feeding)
  • Allergies to oral care products, personal care consumer products, or their ingredients.
  • Medical condition which prohibits not eating/drinking for 4 hours

Treatment and study plan

0.454% stannous fluoride toothpaste

Drug

brush twice daily (morning and evening) Duration of exposure: one (1) minute

5% Potassium nitrate

Drug

Brush twice daily (morning and evening) Duration of exposure: one (1) minute

0.76% sodium monofluorophosphate

Drug

Brush twice daily (morning and evening) Duration of exposure: one (1) minute

Primary outcomes

  1. Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe

    Time frame: baseline, 1 day, 3 day, 7 day

    Tactile sensitivity will be assessed by use of Sensing Probe Yeaple Electronic Force Sensing Probe, Model 200A. Sensitivity will be defined by a score in the range of 10-50 gms. of force.

  2. Air Sensitivity using the Schiff Cold Air Sensitivity Scale

    Time frame: baseline, 1 day, 3 day, 7 day

    The air will be directed at the exposed buccal surface of the sensitive tooth air delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F[± 3°F].

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Dentin Hypersensitivity Reduction Efficacy of a Dentifrice Containing Stannous Fluoride as Compared to Commercially-available Potassium-based Desensitizing Toothpaste.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2026
Registry last updated
Jul 31, 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.

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