Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies

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?

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.

Inclusion Criteria:

1. Sign an Informed Consent Form;

2. Male or female 18 to 70 years of age, inclusive;

3. 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);

4. Willingness to provide information related to their medical history;

5. Available for the two (2) weeks duration of the study;

6. Minimum of 16 uncrowned permanent natural teeth (excluding third molars and crowns);

7. Must present at least two (2) sensitive teeth which must meet ALL of the following criteria:

   1. Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession;
   2. 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.

Exclusion Criteria:

1. Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
2. 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;
3. Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months, dental cleaning it's permitted;
4. Sensitive teeth with a mobility greater than one;
5. Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
6. 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;
7. Current smokers and subjects with a history of alcohol or drug abuse;
8. Participation in any other oral clinical study for the duration of this study;
9. Self-reported pregnancy and/or currently breastfeeding;
10. Allergies to oral care products, personal care consumer products, and/or their ingredients;
11. Medical condition which prohibits not eating/drinking for 4 hours.
12. Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
13. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
14. Current use of orthodontic appliances (including fixed braces, clear aligners, or permanent retainers)