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Completed

NCT Number: NCT06956599

Hypersensitivity Reduction Efficacy: 5% Potassium Nitrate Toothpaste Compared to Colgate Cavity Protection Toothpaste

Assess the clinical efficacy of 5% Potassium Nitrate Toothpaste (Colgate-Palmolive Company, New York, NY, USA) on providing dentinal 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

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

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 three test dentifrices.

Treatment and study plan

test toothpaste

Drug

A commercially available fluoride toothpaste

Control toothpaste

Drug

A commercially available fluoride toothpaste

Primary outcomes

  1. tactile sensitivity

    Time frame: baseline and 4 weeks, 8 week measurement

    tactile stimulation is measured by the Yeaple Electronic Force Sensing Probe

Secondary outcomes

  1. air blast sensitivity

    Time frame: baseline and 4 weeks, 8 week measurement

    air blast sensitivity is delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F [± 3°F]) [sensitivity will be defined by a score of 2 or 3 on the Schiff Cold Air sensitivity scale Air Sensitivity Scale

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Investigation of Hypersensitivity Reduction Efficacy: 5% Potassium Nitrate Toothpaste Compared to Colgate Cavity Protection Toothpaste

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 4, 2025
Registry last updated
Mar 19, 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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