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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensi-IP toothpaste | Experimental | Sodium Fluoride Toothpaste with Sensi-IP |
|
| Sodium fluoride toothpaste | Active Comparator | Sodium Fluoride Toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensi-IP toothpaste | Device | Brushing daily with the Sensi-IP toothpaste for 14 days for dentinal hypersensitivity. |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of adverse events that are possibly, probably, or definitely related to the product | Safety will be evaluated by assessing adverse events. | 14 days |
Inclusion Criteria:
Target Teeth:
Exclusion Criteria:
Target Teeth With:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Doucette | IR Scientific Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Forsyth Institute | Cambridge | Massachusetts | 02142 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8478751 | Background | Richmond NL. Dental hypersensitivity: recent advances in diagnosis and treatment. J Indiana Dent Assoc. 1993 Jan-Feb;72(1):20-2. | |
| 24724135 | Background | Davari A, Ataei E, Assarzadeh H. Dentin hypersensitivity: etiology, diagnosis and treatment; a literature review. J Dent (Shiraz). 2013 Sep;14(3):136-45. |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Sodium Fluoride Toothpaste | Device | Brushing daily with the Sodium Fluoride toothpaste for 14 days for dentinal hypersensitivity. |
|
| 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 |
| 23817061 | Background | Addy M, West NX. The role of toothpaste in the aetiology and treatment of dentine hypersensitivity. Monogr Oral Sci. 2013;23:75-87. doi: 10.1159/000350477. Epub 2013 Jun 28. |
| 11405992 | Background | Poulsen S, Errboe M, Hovgaard O, Worthington HW. Potassium nitrate toothpaste for dentine hypersensitivity. Cochrane Database Syst Rev. 2001;(2):CD001476. doi: 10.1002/14651858.CD001476. |
| 23929643 | Background | Mantzourani M, Sharma D. Dentine sensitivity: past, present and future. J Dent. 2013 Jul;41 Suppl 4:S3-17. doi: 10.1016/S0300-5712(13)70002-2. |
| 36804821 | Background | Shearer A, Montazerian M, Sly JJ, Hill RG, Mauro JC. Trends and perspectives on the commercialization of bioactive glasses. Acta Biomater. 2023 Apr 1;160:14-31. doi: 10.1016/j.actbio.2023.02.020. Epub 2023 Feb 16. |
| 29787782 | Background | Hu ML, Zheng G, Zhang YD, Yan X, Li XC, Lin H. Effect of desensitizing toothpastes on dentine hypersensitivity: A systematic review and meta-analysis. J Dent. 2018 Aug;75:12-21. doi: 10.1016/j.jdent.2018.05.012. Epub 2018 May 19. |
| 35036593 | Background | MacDonald K, Boudreau E, Thomas GV, Badrock TC, Davies LJ, Lloyd MJ, Spradbery PS, Turner-Cahill S, Boyd D. In vitro evaluation of Sensi-IP(R): A soluble and mineralizing sensitivity solution. Heliyon. 2021 Dec 25;8(1):e08672. doi: 10.1016/j.heliyon.2021.e08672. eCollection 2022 Jan. |
| 27813093 | Background | Bakri MM, Hossain MZ, Razak FA, Saqina ZH, Misroni AA, Ab-Murat N, Kitagawa J, Saub RB. Dentinal tubules occluded by bioactive glass-containing toothpaste exhibit high resistance toward acidic soft drink challenge. Aust Dent J. 2017 Jun;62(2):186-191. doi: 10.1111/adj.12484. Epub 2017 May 22. |
| 19472556 | Background | Schiff T, Delgado E, Zhang YP, Cummins D, DeVizio W, Mateo LR. Clinical evaluation of the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity. Am J Dent. 2009 Mar;22 Spec No A:8A-15A. |
| 19831165 | Background | Nathoo S, Delgado E, Zhang YP, DeVizio W, Cummins D, Mateo LR. Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride relative to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in New Jersey, USA. J Clin Dent. 2009;20(4):123-30. |
| 33647373 | Background | Seong J, Newcombe RG, Foskett HL, Davies M, West NX. A randomised controlled trial to compare the efficacy of an aluminium lactate/potassium nitrate/hydroxylapatite toothpaste with a control toothpaste for the prevention of dentine hypersensitivity. J Dent. 2021 May;108:103619. doi: 10.1016/j.jdent.2021.103619. Epub 2021 Feb 26. |
| 41373067 | Derived | Hasturk H, Boyd D, MacDonald-Parsons K, Turner-Cahill S, Seong J, West N, Doucette HJ. Comparative efficacy of novel bioactive glass versus sodium fluoride toothpaste for dentin hypersensitivity: A randomized clinical trial. J Periodontol. 2026 May;97(5):929-944. doi: 10.1002/jper.70024. Epub 2025 Dec 10. |