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Anti-sensitivity Toothpaste

Test toothpaste for Tooth Sensitivity

N/A

Waitlist Available

Research Sponsored by HALEON

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 baseline, day 28 and day 56

Awards & highlights

Study Summary

This trial aims to confirm if a toothpaste containing 0.454% Stannous Fluoride is effective in treating Dentin Hypersensitivity.

Who is the study for?

This trial is for individuals experiencing tooth sensitivity, specifically Dentin Hypersensitivity (DH), who are not allergic to the ingredients in the test products. The study will exclude those with other dental conditions that might affect results.Check my eligibility

What is being tested?

The study tests if a toothpaste containing 0.454% Stannous Fluoride can reduce tooth sensitivity better than regular Crest cavity protection toothpaste. Participants will use one of these two types of toothpaste.See study design

What are the potential side effects?

Possible side effects may include gum irritation or allergic reactions to ingredients in the stannous fluoride or control toothpastes, though such reactions are generally rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 28 and day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 28 and day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 28 and day 56 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 in Schiff Sensitivity Score at Day 56

Secondary outcome measures

Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56

Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56

Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test toothpasteExperimental Treatment1 Intervention

Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wish to rinse after brushing will be instructed to rinse with 10 milliliter (ml) water using graduated rinsing cup provided.

Group II: Reference toothpaste (Negative control)Active Control1 Intervention

Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wish to rinse after brushing will be instructed to rinse with 10 ml water using graduated rinsing cup provided.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stannous fluoride toothpaste

2019

Completed Phase 3

~540

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

HALEONLead Sponsor

29 Previous Clinical Trials

4,056 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for patients in this ongoing clinical trial?

"Yes, current information on clinicaltrials.gov shows that this study is actively seeking participants. This trial was initially listed on March 25th, 2024 and last modified on April 8th of the same year. The aim is to recruit 110 individuals from a single designated site."

Answered by AI

What is the overall participant count in this medical study?

"Indeed, the information available on clinicaltrials.gov highlights that recruitment is ongoing for this investigation. Originally uploaded on March 25th, 2024, with the latest revision dated April 8th, 2024. A total of 110 participants are being sought at a single site."

Answered by AI

Are participants younger than 60 years old eligible for enrollment in this study?

"Eligible candidates for this research endeavor must be between 18 and 65 years old. Among the various clinical trials available, there are 83 focused on participants under 18 and 167 targeted towards individuals above 65 years of age."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers

2024. "Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06359028.