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CompletedNCT07738198Updated Jul 31, 2026

Dentin Hypersensitivity Reduction Efficacy Clinical

A Phase 3 interventional study of 0.454% stannous fluoride toothpaste and 5% potassium nitrate in Dental Hypersensitivity, sponsored by Colgate Palmolive. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2018, 7 years 10 months ago, and no results have been posted to the registry.
  • Registered 7 years 8 months after the study started (first participant enrolled Nov 2018, registered Jul 2026).
Phase
Phase 3
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Dental Hypersensitivity
03

In context

Lead sponsor

Colgate Palmolive is the lead sponsor of 114 studies on the registry; 12 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    Test 1 toothpaste

    Drug: 0.454% stannous fluoride toothpaste

  • Active comparator
    Test 2 toothpaste

    Drug: 5% potassium nitrate

  • Active comparator
    Test 3 toothpaste

    Drug: 0.76% sodium monofluorophosphate

Interventions

  • Drug0.454% stannous fluoride toothpaste

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

  • Drug5% potassium nitrate

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

  • Drug0.76% sodium monofluorophosphate

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

06

What researchers measure

Primary outcomes

  1. Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe

    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.

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

  2. Air Sensitivity using the Schiff Cold Air Sensitivity Scale

    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\[± 3°F\].

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

07

Study locations

1 site
  • FAR Oral and Systemic Health Consulting, Inc
    Costa Mesa, California 92627, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07738198
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
Jul 31, 2026
Start date
Nov 26, 2018
Primary completion
Dec 8, 2018
Completion
Dec 8, 2018
Last update
Jul 31, 2026

Study contacts

Farid Ayad
principal investigator · FAR ORAL SYSTEMIC HEALTH CONSULTING INC.
Maha Hetata
principal investigator · FAR ORAL SYSTEMIC HEALTH CONSULTING INC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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