Status:
COMPLETED
Efficacy of Sensi-IP Toothpaste in the Treatment of Dentinal Hypersensitivity Compared to a Sodium Fluoride Toothpaste
Lead Sponsor:
IR Scientific Inc.
Conditions:
Dentinal Hypersensitivity
Eligibility:
All Genders
18-80 years
Phase:
NA
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 toothpast...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06166745
Start Date
November 6 2023
End Date
April 15 2024
Last Update
April 19 2024
Active Locations (1)
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1
The Forsyth Institute
Cambridge, Massachusetts, United States, 02142