Dental HypersensitivityPhase 3NCT07738198
Dentin Hypersensitivity Reduction Efficacy Clinical
A Phase 3 study testing 0.454% stannous fluoride toothpaste, 5% potassium nitrate and 0.76% sodium monofluorophosphate in people with Dental Hypersensitivity, run by Colgate Palmolive at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Hypersensitivity
- What is being tested?
- 0.454% stannous fluoride toothpaste, 5% potassium nitrate and 0.76% sodium monofluorophosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 8 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
FAR Oral and Systemic Health Consulting, Inc
Costa Mesa, California, 92627
About this study
Official title: Dentin Hypersensitivity Reduction Efficacy of a Dentifrice Containing Stannous Fluoride as Compared to Commercially-available Potassium-based Desensitizing Toothpaste.
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
- Conditions
- Dental Hypersensitivity
- Being tested
- 0.454% stannous fluoride toothpaste, 5% potassium nitrate, 0.76% sodium monofluorophosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.454% stannous fluoride toothpasteDrug
brush twice daily (morning and evening) Duration of exposure: one (1) minute
5% potassium nitrateDrug
Brush twice daily (morning and evening) Duration of exposure: one (1) minute
0.76% sodium monofluorophosphateDrug
Brush twice daily (morning and evening) Duration of exposure: one (1) minute
| Study group | Role | What they receive |
|---|---|---|
| Test 1 toothpaste | Experimental | Not described Receives: Drug: 0.454% stannous fluoride toothpaste |
| Test 2 toothpaste | Active comparator | Not described Receives: Drug: 5% potassium nitrate |
| Test 3 toothpaste | Active comparator | Not described Receives: Drug: 0.76% sodium monofluorophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 day, 3 day, 7 day
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].
Measured: baseline, 1 day, 3 day, 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start26 Nov 2018
- Primary completion8 Dec 2018
- Study completion8 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Farid Ayad, Principal investigator, FAR ORAL SYSTEMIC HEALTH CONSULTING INC.Maha Hetata, Principal investigator, FAR ORAL SYSTEMIC HEALTH CONSULTING INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738198
- Sponsor's protocol ID
- CRO-2018-10-SEN-SNRR-ED
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentin Hypersensitivity Reduction Efficacy of a Dentifrice Containing Stannous Fluoride as Compared to Commercially-available Potassium-based Desensitizing Toothpaste.
- ClinicalTrials.gov ID
- NCT07738198
- Acronym / sponsor ID
- CRO-2018-10-SEN-SNRR-ED
- Conditions
- Dental Hypersensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1 toothpaste | Experimental | Drug: 0.454% stannous fluoride toothpaste |
| Test 2 toothpaste | Active comparator | Drug: 5% potassium nitrate |
| Test 3 toothpaste | Active comparator | Drug: 0.76% sodium monofluorophosphate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.454% stannous fluoride toothpastebrush twice daily (morning and evening) Duration of exposure: one (1) minute | Drug | Test 1 toothpaste |
| 5% potassium nitrateBrush twice daily (morning and evening) Duration of exposure: one (1) minute | Drug | Test 2 toothpaste |
| 0.76% sodium monofluorophosphateBrush twice daily (morning and evening) Duration of exposure: one (1) minute | Drug | Test 3 toothpaste |
Primary outcome
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.
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].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farid Ayad principal investigator
FAR ORAL SYSTEMIC HEALTH CONSULTING INC.
Maha Hetata principal investigator
FAR ORAL SYSTEMIC HEALTH CONSULTING INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.454% stannous fluoride toothpaste, 5% potassium nitrate and 0.76% sodium monofluorophosphate in people with Dental Hypersensitivity, run by Colgate Palmolive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe (time frame: baseline, 1 day, 3 day, 7 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.