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

April 17, 2024 updated by: IR Scientific Inc.

A Prospective, Randomized, Clinical Trial Comparing the Efficacy of Sensi-IP Toothpaste With a Sodium Fluoride Toothpaste in the Treatment of Dentinal Hypersensitivity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02142
        • The Forsyth Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

  1. Demonstrate cervical dentin exposure, which may be visible with the use of loupes
  2. 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:

  1. Extensive or unsatisfactory restorations fractures, periodontal alterations, caries lesions, orthodontic brackets, endodontic treatments, or pulp alterations interfering confounding evaluations
  2. Crowns, veneers, or bridges

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensi-IP toothpaste
Sodium Fluoride Toothpaste with Sensi-IP
Device: Sensi-IP toothpaste
Brushing daily with the Sensi-IP toothpaste for 14 days for dentinal hypersensitivity.
Active Comparator: Sodium fluoride toothpaste
Sodium Fluoride Toothpaste
Device: Sodium Fluoride Toothpaste
Brushing daily with the Sodium Fluoride toothpaste for 14 days for dentinal hypersensitivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline at Day 14 using the Schiff Airblast Sensitivity Score
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of adverse events that are possibly, probably, or definitely related to the product
Time Frame: 14 days
Safety will be evaluated by assessing adverse events.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IR Scientific Inc.

Investigators

  • Study Director: Heather Doucette, IR Scientific Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Actual)

December 23, 2023

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

December 3, 2023

First Submitted That Met QC Criteria

December 3, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIP001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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