Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColgate Palmolive
About this 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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
8% arginine + Zinc toothpaste
DrugA commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate
5% Calcium Sodium Phosphosilicate toothpaste
DrugA commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS)
8% arginine toothpaste
DrugA commercially available fluoride toothpaste containing 8% arginine
Treatment groups
132 Participants
are divided into 3 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Active Comparator GroupActive comparator 1 intervention
Group C: Positive Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline and Immediately post-treatment2
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 Day3
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 Days4
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 DaysSecondary outcomes
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.
Time frame
Baseline and Immediately post-treatment2
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 Day3
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 Days4
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 DaysSponsors and contacts
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Colgate Palmolive
Lead sponsor
Federal University of Rio Grande do Sul
Collaborator
Source ClinicalTrials.gov