Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies

NCT07664592 | Recruiting Phase 3 DMC

• 1 other identifier: CRO-2026-02-SEN-BZ-CB
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Dentinal Sensitivity; Dentinal Hypersensitivity

Keywords

Dentin Hypersensitivity; Arginine; Oral Health Quality of Life; Sensitive Teeth

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline and 14 Days

Secondary Outcomes (6)

• Change from Baseline in Tactile Stimulus (1)

  Baseline and Immediately post-treatment

• Change from Baseline in Tactile Stimulus (2)

  Baseline and 1 Day

• Change from Baseline in Tactile Stimulus (3)

  Baseline and 3 Days

• Change from Baseline in Tactile Stimulus (4)

  Baseline and 7 Days

• Change from Baseline in Tactile Stimulus (5)

  Baseline and 14 Days

Study Arms (3)

Experimental Group

EXPERIMENTAL

A commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate, paired with a commercially available adult soft bristle toothbrush

Drug: 8% arginine + Zinc toothpaste

Active Comparator Group

ACTIVE COMPARATOR

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

Positive Control Group

ACTIVE COMPARATOR

A commercially available fluoride toothpaste containing 8% arginine, paired with a commercially available adult soft bristle toothbrush

Drug: 8% arginine toothpaste

Interventions

8% arginine + Zinc toothpaste DRUG

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

Experimental Group

5% Calcium Sodium Phosphosilicate toothpaste DRUG

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

Active Comparator Group

8% arginine toothpaste DRUG

A commercially available fluoride toothpaste containing 8% arginine

Positive Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• 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)

Sponsors & Collaborators

• Colgate Palmolive: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

IEAPOM

Porto Alegre, Rio Grande do Sul, 91530-001, Brazil

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Arginine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Cassiano K Rosing, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassiano K Rosing, PhD

CONTACT

5551995119123; ckrosing@hotmail.com

Juliano Cavagni, PhD

CONTACT

5551995911703; jcavagni@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind (Toothpastes will be covered with white over-wrapping to conceal product identity, blinding the subjects, the examining dentist, their staff, and outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 29, 2026
• Primary Completion: July 21, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)