An interventional study of Sensi-IP toothpaste and Sodium Fluoride Toothpaste in Dentinal Hypersensitivity, sponsored by IR Scientific Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by IR Scientific Inc. · Not applicable, Interventional, and Treatment
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.
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
289 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 280 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →This is the only study on the registry with IR Scientific Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Target Teeth:
Exclusion Criteria:
Target Teeth With:
Sodium Fluoride Toothpaste with Sensi-IP
Device: Sensi-IP toothpaste
Sodium Fluoride Toothpaste
Device: Sodium Fluoride Toothpaste
Brushing daily with the Sensi-IP toothpaste for 14 days for dentinal hypersensitivity.
Brushing daily with the Sodium Fluoride toothpaste for 14 days for dentinal hypersensitivity.
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.
Time frame: 14 Days
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.
Time frame: 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.
Time frame: 14 Days
The occurrence of adverse events that are possibly, probably, or definitely related to the product
Safety will be evaluated by assessing adverse events.
Time frame: 14 days
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.