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Dentinal HypersensitivityNCT06166745

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

A study testing Sensi-IP toothpaste and Sodium Fluoride Toothpaste in people with Dentinal Hypersensitivity, run by IR Scientific Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Dentinal Hypersensitivity
What is being tested?
Sensi-IP toothpaste and Sodium Fluoride Toothpaste
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
6 Nov 2023to 15 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Forsyth Institute

    Cambridge, Massachusetts, 02142

Other trials in United States

About this study

Official title: 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.

Read the 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

Being tested
Sensi-IP toothpaste, Sodium Fluoride Toothpaste
Keywords
Fluoride, Dentine Hypersensitivity, Toothpaste
Medical subject headings
Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensi-IP toothpasteDevice

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

  • Sodium Fluoride ToothpasteDevice

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

Study groups in NCT06166745
Study groupRoleWhat they receive
Sensi-IP toothpasteExperimentalSodium Fluoride Toothpaste with Sensi-IP
Receives: Device: Sensi-IP toothpaste
Sodium fluoride toothpasteActive comparatorSodium Fluoride Toothpaste
Receives: Device: Sodium Fluoride Toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 Days

Secondary outcomes (2)

  1. 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.

    Measured: 14 Days

  2. 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.

    Measured: 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2023
  2. Study start6 Nov 2023
  3. Primary completion23 Dec 2023
  4. Study completion15 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06166745
Sponsor's protocol ID
SIP001
Status last verified
Apr 2024
First submitted
3 Dec 2023
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Richmond NL. Dental hypersensitivity: recent advances in diagnosis and treatment. J Indiana Dent Assoc. 1993 Jan-Feb;72(1):20-2.

    PubMed 8478751

  • Davari A, Ataei E, Assarzadeh H. Dentin hypersensitivity: etiology, diagnosis and treatment; a literature review. J Dent (Shiraz). 2013 Sep;14(3):136-45.

    PubMed 24724135

  • 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.

    PubMed 23817061

  • 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.

    PubMed 11405992

  • 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.

    PubMed 23929643

  • 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.

    PubMed 36804821

  • 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.

    PubMed 29787782

  • 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.

    PubMed 35036593

  • 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.

    PubMed 27813093

  • 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.

    PubMed 19472556

  • 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.

    PubMed 19831165

  • 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.

    PubMed 33647373

  • 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.

    PubMed 41373067

Questions about this trial

What is this clinical trial studying?

A study testing Sensi-IP toothpaste and Sodium Fluoride Toothpaste in people with Dentinal Hypersensitivity, run by IR Scientific Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline at Day 14 using the Schiff Airblast Sensitivity Score (time frame: 14 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06166745, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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