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Sensi-IP toothpaste for Tooth Sensitivity

N/A

Waitlist Available

Research Sponsored by IR Scientific Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study Summary

This trial studies if a toothpaste with Sensi-IP +NaF can reduce tooth sensitivity in adults more than just NaF toothpaste. 46 participants aged 18-80 will be enrolled & evaluated for efficacy & adverse events.

Who is the study for?

Adults aged 18-80 with sensitive teeth, willing to avoid other dental treatments and oral hygiene products during the trial. Participants must have at least two sensitive teeth in different quadrants of the mouth, anterior to the molars. Excluded are those pregnant, breastfeeding, with recent dental work or desensitizing treatments, active oral issues like ulcers or severe gum disease, certain medical conditions affecting saliva flow or sensitivity perception.Check my eligibility

What is being tested?

The study compares Sensi-IP toothpaste combined with sodium fluoride (NaF) against a standard NaF toothpaste for reducing tooth sensitivity over 14 days. It's a randomized and double-blinded pilot trial involving two groups: one using Sensi-IP + NaF toothpaste and another using only NaF toothpaste.See study design

What are the potential side effects?

Potential side effects may include reactions to ingredients in the Sensi-IP toothpaste such as flavor components which could cause allergic responses or further sensitivity in some individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline at Day 14 using the Schiff Airblast Sensitivity Score

Secondary outcome measures

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

Change from baseline at Day 14 using the Yeaple probe assessment

Other outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sensi-IP toothpasteExperimental Treatment1 Intervention

Sodium Fluoride Toothpaste with Sensi-IP

Group II: Sodium fluoride toothpasteActive Control2 Interventions

Sodium Fluoride Toothpaste

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sensi-IP toothpaste

2023

N/A

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

IR Scientific Inc.Lead Sponsor

IR Scientific IncLead Sponsor

Heather DoucetteStudy DirectorIR Scientific Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration still open for participants in this research project?

"Affirmative. As per the information hosted on clinicaltrials.gov, this trial is recruiting participants now. The initial posting was created on November 6th 2023 and the most recent update occurred December 3rd of that same year. We are aiming to enrol 46 patients at one medical centre in total."

Answered by AI

Do I meet the criteria to be recruited for this experiment?

"Eligibility requirements for this study entail participants feeling tooth sensitivity and having an age between 18 to 80. A maximum of 46 individuals can join the trial."

Answered by AI

Is this research study admitting participants who are sixty or older?

"This clinical trial is available to adults aged 18-80. 90 trials are currently open for those under the age of majority and 172 trails have been opened up for elderly patients over 65 years old."

Answered by AI

How many individuals have been enrolled in this medical experiment?

"Affirmative. According to the information provided on clinicaltrials.gov, this trial is actively recruiting participants with a start date of November 6th 2023 and an update posted December 3rd 2023. The study requires 46 patients from 1 medical centre for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Efficacy of Sensi-IP Toothpaste in the Treatment of Dentinal Hypersensitivity Compared to a Sodium Fluoride Toothpaste". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06166745.