BridgeMD
Tests treatment safety and results for Dentinal Sensitivity
Official title Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies
ClinicalTrials.gov ID: NCT07664592
What this study is testing
What is 8% arginine + Zinc toothpaste?
8% arginine + Zinc toothpaste is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for dentinal sensitivity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- Willingness to provide information related to their medical history;
- Available for the two (2) weeks duration of the study;
You likely can't join 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...
- 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...
- Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, daily use of analgesics within...
See the full eligibility criteria
- 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...
- 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.
- 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...
- Current smokers and people 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)
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.