A Phase 3 interventional study of 8% arginine + Zinc toothpaste and 5% Calcium Sodium Phosphosilicate toothpaste in Dentinal Sensitivity and Dentinal Hypersensitivity, sponsored by Colgate Palmolive. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment
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?
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.
288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.
This study's planned enrollment of 132 is above the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →Colgate Palmolive is the lead sponsor of 119 studies on the registry; 13 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must present at least two (2) sensitive teeth which must meet ALL of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate, paired with a commercially available adult soft bristle toothbrush
Drug: 8% arginine + Zinc toothpaste
A commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS), paired with a commercially available adult soft bristle toothbrush
Drug: 5% Calcium Sodium Phosphosilicate toothpaste
A commercially available fluoride toothpaste containing 8% arginine, paired with a commercially available adult soft bristle toothbrush
Drug: 8% arginine toothpaste
A commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate
A commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS)
A commercially available fluoride toothpaste containing 8% arginine
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.
Time frame: Baseline and Immediately post-treatment
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.
Time frame: Baseline and 1 Day
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.
Time frame: Baseline and 3 Days
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.
Time frame: Baseline and 7 Days
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.
Time frame: Baseline and 14 Days
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.
Time frame: Baseline and Immediately post-treatment
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.
Time frame: Baseline and 1 Day
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.
Time frame: Baseline and 3 Days
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.
Time frame: Baseline and 7 Days
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.
Time frame: Baseline and 14 Days
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.
Time frame: Baseline and 14 Days
Plan to share: No
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