Efficacy of Sensi-IP Toothpaste in the Treatment of Dentinal Hypersensitivity Compared to a Sodium Fluoride Toothpaste

Study Overview
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Brief Summary
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The study is designed as a prospective, randomized, parallel arm, double blinded, pilot clinical trial.The primary objective is to evaluate the efficacy of Sensi-IP +NaF as compared to a NaF toothpaste in the reduction of dentin hypersensitivity in adult participants over 14 days. Study endpoints include Evaporative Air blast Stimuli (Schiff Airblast Sensitivity Score), Tactile Stimuli (Yeaple probe Assessment), Visual Analogue Scale Evaporative Stimuli and the occurrence of adverse events. The study will include 2 study arms: 1. Sodium fluoride toothpaste with Sensi IP (N=23) and 2. Sodium fluoride toothpaste (N=23). Total of 46 participants (ages 18-80 years) with at least one hypersensitive tooth in 2 different quadrants which are anterior to the molars will be enrolled.

Detailed Description
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The Study design is a prospective, randomized, parallel arm, double blinded, single study site, proof of concept clinical trial. The study will include 2 study arms: 1) Brushing with sodium fluoride toothpaste with Sensi IP (N=23) and 2) Brushing with sodium fluoride toothpaste (N=23). A total of 46 adults (18 - 80 years of age) will be included in this clinical trial. To account for the potential of a 15% drop out, as many as 46 participants may be enrolled and treated with the goal of 20 participants per arm. Study procedures will take place at the following timelines shown below: Visit 1: Screening Visit -Informed consent; Screening for eligibility Visit 2: Baseline Day 1: 7 days post screening; (+/- 1 Day) -Confirm eligibility, 1st treatment with allocated product Visit 3 Day 2: 1 Day after Visit 2; (+1 Day) -Study Assessments Visit 4: Day 14 (14 days after Visit 2 ;+/ 2 Days) -Final Study Assessments and Study Exit

Official Title
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A Prospective, Randomized, Proof-of-Concept Study Comparing the Efficacy of Sensi-IP Toothpaste With a Sodium Fluoride Toothpaste in the Treatment of Dentinal Hypersensitivity

Conditions
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Dentinal Hypersensitivity

Intervention / Treatment
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* Device: Sensi-IP toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to abide by the terms of the consent form Can independently sign informed consent Participants 18-80 years old Agree to abstain from any other desensitizing, (stannous fluoride, arginine, calcium phosphosilicate, nanohydroxy apatite, potassium nitrate and varieties) whitening or other dental procedures for the duration of the trial Agree to refrain from all oral hygiene procedures (in addition to the Study Product) and chewing gum for 8 h prior to each scheduled visit and refrained from eating and drinking for 4 h prior to each visit (sips of water is allowed for taking routine medications). Have at least two hypersensitive teeth (≥2 Schiff Airblast Sensitivity Score) consistent at screening and baseline. Target Teeth: Demonstrate cervical dentin exposure, which may be visible with the use of loupes Are non-adjacent in 2 different quadrants, anterior to the molars. Exclusion Criteria: Are pregnant (to be confirmed by an over-the-counter dipstick pregnancy test) or breast feeding Have lip or tongue piercing which the subject is unwilling to remove for the duration of the study Have an active oral ulcer (Aphthous ulcer) at the time of screening Have undergone desensitizing treatment (stannous fluoride, arginine, calcium phosphosilicate, nanohydroxy apatite, potassium nitrate and varieties) within the 1 month preceding the screening visit Have undergone tooth bleaching within 8 weeks of screening Have undergone scale, polish, interventional dental procedures within 1 month of screening Are currently undergoing orthodontics Receiving concomitant medication/therapy that might affect dentine hypersensitivity, e.g., regular use (>3X per week) of analgesics, antihistamines, non-steroidal anti-inflammatory drug, and selective serotonin reuptake inhibitor medication Demonstrate severe bruxism as indicated by reported muscular pain Reduced salivary flow as determined by clinical assessment and/or patient report, diagnosed with Sjogren's disease, received radiation therapy to the head or neck within a year or currently being on medications that may cause xerostomia Have generalized gingivitis or active periodontal disease as determined by the clinical exam or undergoing treatment for the above disease Have had gingival surgery in the previous six months Have allergies to any Study toothpaste ingredients, including the flavor components With active caries or any condition such as pulpitis that would precipitate mouth pain Who have self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity Participated in other clinical trials in the previous 28 days Have smoked/vaped or used marijuana in the previous 12 months Are diagnosed with unstable mental illness or chronic pain (e.g., fibromyalgia, TMD, migraine, etc.) that could alter the Participant's ability to report pain accurately In the opinion of the Investigator, are unable to comply fully with the trial requirements Target Teeth With: Extensive or unsatisfactory restorations fractures, periodontal alterations, caries lesions, orthodontic brackets, endodontic treatments, or pulp alterations interfering confounding evaluations Crowns, veneers, or bridges

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensi-IP toothpaste<br>Sodium Fluoride Toothpaste with Sensi-IP | Device: Sensi-IP toothpaste<br>* Brushing daily with the Sensi-PI or sodium fluoride toothpaste for 14 days to decrease dentinal hypersensitivity<br>|
| Active Comparator: Sodium fluoride toothpaste<br>Sodium Fluoride Toothpaste | Device: Sensi-IP toothpaste<br>* Brushing daily with the Sensi-PI or sodium fluoride toothpaste for 14 days to decrease dentinal hypersensitivity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at Day 14 using the Schiff Airblast Sensitivity Score | Schiff Airblast sensitivity score is mainly used to assess participant response to evaporated air stimuli. The scale is 0-3 and higher scores mean a worse outcome. | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at Day 14 using the Yeaple probe assessment | Dentin Hypersensitivity in response to tactile stimulus is to be determined by Yeaple probe. Teeth were evaluated by stroking the probe across the buccal surface at the cementoenamel junction, perpendicular to the tooth. The preset force exerted by the probe initially was set to 10 gram and was increased progressively in 10-gram increments up to 70 grams or until the patient first reported experiencing discomfort. Higher scores mean a better outcome. | 14 Days | 
| Change from baseline at Day 14 using the Visual Analogue Score (VAS) for pain following evaporative stimuli | Participants response to evaporative stimuli will be measured by asking participants to rate their pain from zero to 10 (using a 10 cm scale). Higher scores mean worse outcome. | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluoride, Dentine Hypersensitivity, Toothpaste