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Anti-sensitivity Toothpaste
Stannous Fluoride 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
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Schiff Sensitivity Score at Day 56
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~770
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Who is running the clinical trial?
HALEONLead Sponsor
35 Previous Clinical Trials
5,276 Total Patients Enrolled
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