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AzTrials

Dentinal SensitivityPhase 3SENSBZNCT07664592

Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies

A Phase 3 study testing 8% arginine + Zinc toothpaste, 5% Calcium Sodium Phosphosilicate toothpaste and 8% arginine toothpaste in people with Dentinal Sensitivity and Dentinal Hypersensitivity, run by Colgate Palmolive at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this clinical study is to evaluate and compare how well three different types of toothpaste technologies work to relieve tooth sensitivity, also known as dentin hypersensitivity. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
8% arginine + Zinc toothpaste, 5% Calcium Sodium Phosphosilicate toothpaste and 8% arginine toothpaste
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteBrazil
Study dates
29 Jun 2026to Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • 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 (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
  • Willingness to provide information related to their medical history;
  • Available for the two (2) weeks duration of the study;
  • Minimum of 16 uncrowned permanent natural teeth (excluding third molars and crowns);
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  • Must present at least 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 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 month prior to start of the study;
  • Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months, dental cleaning it's permitted;
  • 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, daily use of analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner; or other drugs that could affect pain sensation;
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  • Current smokers and subjects with a history of alcohol or drug abuse;
  • 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.
  • Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
  • Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
  • Current use of orthodontic appliances (including fixed braces, clear aligners, or permanent retainers)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cassiano K Rosing, PhD contact

5551995119123

ckrosing@hotmail.com

Juliano Cavagni, PhD contact

5551995911703

jcavagni@hotmail.com

Brazil1 site, 1 recruiting
  • IEAPOM

    Porto Alegre, Rio Grande do Sul, 91530-001

    Cassiano K Rosing, PhD, 5551 9511-9123, ckrosing@hotmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies on Instant and Short-term Relief of Dentin Hypersensitivity: a Randomized Clinical Trial

The purpose of this clinical study is to evaluate and compare how well three different types of toothpaste technologies work to relieve tooth sensitivity, also known as dentin hypersensitivity. The study asks the question: How effective are toothpastes containing 8% Arginine, 8% Arginine with Zinc Phosphate, or 5% Calcium Sodium Phosphosilicate (CSPS) at providing immediate and short-term relief for people suffering from sensitive teeth?

Read the detailed description

Dentin hypersensitivity (DH) is a common condition characterized by short, sharp pain arising from exposed dentin in response to external stimuli. This study investigates the clinical efficacy of three distinct dentin-occluding toothpaste technologies (8% Arginine, 8% Arginine with Zinc Phosphate, and 5% Calcium Sodium Phosphosilicate) to determine their effectiveness in providing both immediate (in-office) and short-term (14-day) relief.

Study Procedures and Visit Flow: During the screening phase, a trained dental examiner will evaluate potential participants to ensure they have at least two qualifying hypersensitive teeth (located anterior to the molars). Sensitivity is confirmed using an evaporative air blast stimulus delivered from a standard dental syringe.

At the baseline visit, eligible participants will complete the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) to assess the impact of DH on their quality of life. Clinical sensitivity will then be assessed using both tactile stimuli (measured via a 100-mm Visual Analogue Scale) and evaporative air blast stimuli (measured via the Schiff Cold Sensitivity Scale).

Following baseline assessments, participants are randomly assigned to one of the three study groups using a computer-generated block randomization list. To maintain the double-blind design for the subjects, the examining dentist, and the clinical staff, all investigational toothpastes are dispensed in a separate room and covered with white over-wrapping to conceal the product's identity and account for any aesthetic differences

Intervention Application: A key procedural component of this protocol is the evaluation of immediate relief following the first use of the products. Immediately after this initial application, clinical sensitivity (tactile and air blast) is re-evaluated.

For the at-home phase, all participants will be provided with their assigned toothpaste and a commercially available adult soft-bristled toothbrush. They will be instructed to brush their entire mouth for two minutes, twice daily (morning and evening), for the remainder of the 14-day study.

Follow-Up Restrictions: Participants will return to the clinical site for follow-up evaluations after 1, 3, 7, and 14 days of at-home product use. To ensure accurate sensitivity readings, participants are required to strictly refrain from any oral hygiene procedures, chewing gum, eating, and drinking for four hours prior to each of these follow-up visits.

Statistical Analysis Plan: The study is designed to enroll 132 subjects, allowing for an approximate 20% attrition rate to ensure that around 106 participants complete the 14-day trial. The sample size provides 80% power to detect a minimal statistically significant difference of 20% between the treatment group means.

Efficacy will be determined using an Analysis of Covariance (ANCOVA). The analysis will use the change from baseline scores as a covariate, and will also include age and gender as covariates if significant differences are found at baseline. If the ANCOVA reveals a significant difference among the groups, a Tukey's multiple comparison test will be performed for post-hoc evaluation.

Being tested
8% arginine + Zinc toothpaste, 5% Calcium Sodium Phosphosilicate toothpaste, 8% arginine toothpaste
Keywords
Dentin Hypersensitivity, Arginine, Oral Health Quality of Life, Sensitive Teeth
Medical subject headings
Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 8% arginine + Zinc toothpasteDrug

    A commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate

  • 5% Calcium Sodium Phosphosilicate toothpasteDrug

    A commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS)

  • 8% arginine toothpasteDrug

    A commercially available fluoride toothpaste containing 8% arginine

Study groups in NCT07664592
Study groupRoleWhat they receive
Experimental GroupExperimentalA commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate, paired with a commercially available adult soft bristle toothbrush
Receives: Drug: 8% arginine + Zinc toothpaste
Active Comparator GroupActive comparatorA commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS), paired with a commercially available adult soft bristle toothbrush
Receives: Drug: 5% Calcium Sodium Phosphosilicate toothpaste
Positive Control GroupActive comparatorA commercially available fluoride toothpaste containing 8% arginine, paired with a commercially available adult soft bristle toothbrush
Receives: Drug: 8% arginine toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Dentin Hypersensitivity (1)

    Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.

    Measured: Baseline and Immediately post-treatment

  2. Title: Change from Baseline in Dentin Hypersensitivity (2)

    Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.

    Measured: Baseline and 1 Day

  3. Title: Change from Baseline in Dentin Hypersensitivity (3)

    Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.

    Measured: Baseline and 3 Days

  4. Title: Change from Baseline in Dentin Hypersensitivity (4)

    Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.

    Measured: Baseline and 7 Days

  5. Title: Change from Baseline in Dentin Hypersensitivity (5)

    Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.

    Measured: Baseline and 14 Days

Secondary outcomes (6)
  1. Change from Baseline in Tactile Stimulus (1)

    Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.

    Measured: Baseline and Immediately post-treatment

  2. Change from Baseline in Tactile Stimulus (2)

    Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.

    Measured: Baseline and 1 Day

  3. Change from Baseline in Tactile Stimulus (3)

    Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.

    Measured: Baseline and 3 Days

  4. Change from Baseline in Tactile Stimulus (4)

    Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.

    Measured: Baseline and 7 Days

  5. Change from Baseline in Tactile Stimulus (5)

    Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.

    Measured: Baseline and 14 Days

  6. Change from Baseline in Quality of Life Impact (DHEQ-15)

    The impact of dentin hypersensitivity on participants' quality of life is assessed using the Brazilian version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15). This self-reported instrument consists of 15 items categorized into five domains: restrictions, adaptation, social impact, emotional impact, and identity. Each item is scored on a 7-point Likert scale, ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The total score ranges from 15 to 105, where higher scores reflect a greater negative impact on the individual's quality of life. This measure evaluates the change in total score from baseline.

    Measured: Baseline and 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start29 Jun 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07664592
Sponsor's protocol ID
CRO-2026-02-SEN-BZ-CB
Acronym
SENSBZ
Status last verified
Jul 2026
First submitted
18 Jun 2026
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 8% arginine + Zinc toothpaste, 5% Calcium Sodium Phosphosilicate toothpaste and 8% arginine toothpaste in people with Dentinal Sensitivity and Dentinal Hypersensitivity, run by Colgate Palmolive at 1 site in Brazil.

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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 7 Aug 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 Brazil. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cassiano K Rosing, PhD (5551995119123, ckrosing@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Dentin Hypersensitivity (1) (time frame: Baseline and Immediately post-treatment). The study lists 5 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 7 Aug 2026.

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