Dentinal HypersensitivityPhase 3NCT06244290
Dentinal Hypersensitivity Reduction
A Phase 3 study testing Colgate SNF, Sensodyne Extra Whitening and Colgate Fluoride (CDC) in people with Dentinal Hypersensitivity, run by Colgate Palmolive at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- Colgate SNF, Sensodyne Extra Whitening and Colgate Fluoride (CDC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 21 Oct 2020
- 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
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- Colgate SNF, Sensodyne Extra Whitening, Colgate Fluoride (CDC)
- Keywords
- tactile, airblast, dentin hypersensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate SNFDrug
toothpaste
Sensodyne Extra WhiteningDrug
toothpaste
Colgate Fluoride (CDC)Drug
toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush Receives: Drug: Colgate SNF |
| Group II | Active comparator | Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush Receives: Drug: Sensodyne Extra Whitening |
| Group III | Placebo comparator | Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush Receives: Drug: Colgate Fluoride (CDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile dentin hypersensitivity
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)
Measured: Baseline, 1-Day, 3-Days and 7-Days
Air blast dentin hypersensitivity
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.
Measured: Baseline, 1-Day, 3-Days and 7-Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start28 Sep 2020
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinal 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Farid Ayad, DMD, MSD, Principal investigator, Mesa Dental Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244290
- Sponsor's protocol ID
- CRO-2020-05-SEN-SNF-CA-BGS
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06244290
- Acronym / sponsor ID
- CRO-2020-05-SEN-SNF-CA-BGS
- Conditions
- Dentinal Hypersensitivity
- Keywords
- tactile, airblast, dentin hypersensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 6 Feb 2024 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Colgate SNFColgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush |
| Group II | Active comparator | Drug: Sensodyne Extra WhiteningSensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush |
| Group III | Placebo comparator | Drug: Colgate Fluoride (CDC)Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| Colgate SNFtoothpaste | Drug | Group I |
| Sensodyne Extra Whiteningtoothpaste | Drug | Group II |
| Colgate Fluoride (CDC)toothpaste | Drug | Group III |
Primary outcome
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)
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.
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 18 Mar 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, DMD, MSD principal investigator
Mesa Dental Centre
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 Colgate SNF, Sensodyne Extra Whitening and Colgate Fluoride (CDC) in people with Dentinal 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 10 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 18 Mar 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. Some participants in this study may receive a placebo. 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 dentin hypersensitivity (time frame: Baseline, 1-Day, 3-Days and 7-Days). 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 18 Mar 2026.