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

NCT06166745 | Completed FDA Device

• 1 other identifier: SIP001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dentinal Hypersensitivity

Keywords

Fluoride; Dentine Hypersensitivity; Toothpaste

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline at Day 14 using the Yeaple probe assessment

  14 Days

• Change from baseline at Day 14 using the Visual Analogue Score (VAS) for pain following evaporative stimuli

  14 Days

Other Outcomes (1)

• The occurrence of adverse events that are possibly, probably, or definitely related to the product

  14 days

Study Arms (2)

Sensi-IP toothpaste

EXPERIMENTAL

Sodium Fluoride Toothpaste with Sensi-IP

Device: Sensi-IP toothpaste

Sodium fluoride toothpaste

ACTIVE COMPARATOR

Sodium Fluoride Toothpaste

Device: Sodium Fluoride Toothpaste

Interventions

Sensi-IP toothpaste DEVICE

Brushing daily with the Sensi-IP toothpaste for 14 days for dentinal hypersensitivity.

Sensi-IP toothpaste

Sodium Fluoride Toothpaste DEVICE

Brushing daily with the Sodium Fluoride toothpaste for 14 days for dentinal hypersensitivity.

Sodium fluoride toothpaste

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IR Scientific Inc.: lead

Study Sites (1)

The Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Location

Related Publications (13)

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  PMID: 8478751 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.

  PMID: 24724135 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.

  PMID: 23817061 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.

  PMID: 11405992 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.

  PMID: 23929643 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.

  PMID: 36804821 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.

  PMID: 29787782 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.

  PMID: 35036593 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.

  PMID: 27813093 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.

  PMID: 19472556 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.

  PMID: 19831165 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.

  PMID: 33647373 BACKGROUND

• 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. J Periodontol. 2025 Dec 10. doi: 10.1002/jper.70024. Online ahead of print.

  PMID: 41373067 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Heather Doucette

  IR Scientific Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: November 6, 2023
• Primary Completion: December 23, 2023
• Study Completion: April 15, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

US (1)