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New toothpaste could ease tooth pain for millions

NCT ID NCT06378008

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether a toothpaste with calcium sodium phosphosilicate (CSPS) can reduce tooth sensitivity. 217 adults with sensitive teeth used either the CSPS toothpaste or a regular fluoride toothpaste for 8 weeks. Researchers measured how teeth responded to air and touch to see if the special toothpaste helped more than the regular one.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
calcium sodium phosphosilicate toothpaste
What this could lead to
If it works, this could provide a simple, at-home option for people with sensitive teeth to reduce pain from air or touch.
What could go wrong
This is a completed study, but results may not apply to everyone. Tooth sensitivity can have many causes, and the toothpaste may not work for all types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

217 people

The number who actually took part.

Started

Apr 2024

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant provision of signed and dated informed consent before any study procedures are performed. * Participant is male or female. * Participant is 18 to 65 years of age, inclusive, at the time of signing the informed consent. * Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures. * Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination, that would impact their safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements. * Screening (visit 1): Participant must have 1. History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported). 2. Good general oral health, with a minimum of 20 natural teeth. 3. Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria: 1. Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR). 2. Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only). 3. Clinical mobility = 0 4. Clinically confirmed DH to both tactile and evaporative (air) stimuli: a) Qualifying tactile threshold less than or equal to (\<=) 20g. b) Qualifying Schiff sensitivity score greater than or equal to (\>=) 2. * Baseline (Visit 2, Pre-Treatment): Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), in different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both screening (Visit 1) and baseline (Visit 2). a) Qualifying tactile threshold \<= 20g at screening and baseline. b) Qualifying Schiff sensitivity score \>= 2 at screening and baseline. Exclusion Criteria: * Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family. * Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family. * Female participant who is pregnant or intending to become pregnant during the study (self-reported). * Female participant who is breastfeeding (self-reported). * Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported). * Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported). * Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study. * Participant has participated in a tooth sensitivity study within 8 weeks of screening (Visit 1). * Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-sensitivity product within 8 weeks of screening (Visit 1). Participants will be required to bring their current oral care products to screening (Visit 1) for staff to verify the absence of known anti-sensitivity ingredients and sensitivity-related claims on the product packaging/label text. * Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs). * Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to screening (Visit 1). * Baseline (Visit 2, Pre-Treatment): Participant has taken antibiotics in the 2 weeks prior to baseline (Visit 2), that is, during the acclimatization period. * Participant takes daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia. * Participant requires antibiotic prophylaxis for dental procedures. * Participant has had professional tooth de-sensitising treatment within 8 weeks of screening (Visit 1). * Participant has had a tooth bleaching procedure within 8 weeks of screening (Visit 1). * Participant has had dental prophylaxis within 4 weeks of screening (Visit 1). * Participant has had treatment for periodontal disease (including surgery) within 12 months of screening (Visit 1). * Participant has had scaling or root planning within 3 months of screening (Visit 1). * Participant with gross periodontal disease. * Participant with a tongue or lip piercing. * Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy. * Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes. * Participant with multiple dental implants which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes. * Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer. * Specific dentition exclusions for 'Test teeth': 1. Tooth with evidence of current/recent caries. 2. Tooth with (self-reported) treatment for decay within 12 months of screening (Visit 1). 3. Tooth with exposed dentin and deep, defective or facial restorations. 4. Tooth with a full crown or veneer. 5. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes. 6. Sensitive tooth with contributing etiologies other than EAR to exposed dentin. 7. Sensitive tooth not expected to benefit from use of an anti-sensitivity toothpaste, in the opinion of the investigator or dentally qualified designee. * Participant has previously been enrolled in this study. * Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • All Sum Research

    Mississauga, Ontario, L5N 6J2, Canada

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Other studies related to the condition(s) this trial covers.