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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 who experience tooth sensitivity, specifically Dentin Hypersensitivity (DH). Participants should not have allergies that would affect the trial. The full eligibility criteria are not provided.Check my eligibility
What is being tested?
The study tests if a toothpaste containing 0.454% Stannous Fluoride can better reduce tooth sensitivity compared to regular fluoride toothpaste like Crest Cavity Protection.See study design
What are the potential side effects?
Potential side effects may include gum irritation, altered taste sensation, or mouth sores due to the stannous fluoride component in the tested toothpaste.

Timeline

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

Find a Location

Who is running the clinical trial?

HALEONLead Sponsor
29 Previous Clinical Trials
4,052 Total Patients Enrolled

Frequently Asked Questions

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

Which individuals are eligible to take part in this clinical research study?

"Candidates with tooth sensitivity aged between 18 and 65 are eligible for participation in this trial, which aims to enroll approximately 110 individuals."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"The study, as per clinicaltrials.gov, is not actively seeking participants. Originally posted on April 11th, 2024 and last revised on April 3rd, 2024. Despite this trial no longer recruiting patients, there are currently 269 other trials available for enrollment."

Answered by AI

Is the enrollment limited to participants younger than 60 years of age?

"Participants must be between 18 and 65 years old to qualify for this investigation. There are a total of 83 trials tailored for individuals under 18, and another set of 166 aimed at those over the age of 65."

Answered by AI
~57 spots leftby Jun 2024