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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
All genders who, at the time of screening, are aged between 18 and 65 years (inclusive)
Participant who is able to independently complete all the assigned activities on their smart devices
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 1, 2, 4, 8, 12, 16, 20, 24
Awards & highlights

Study Summary

This trial will evaluate how a special toothpaste helps people with sensitive teeth to improve their oral health and quality of life.

Who is the study for?
This trial is for adults aged 18-65 with self-reported tooth sensitivity but no active periodontitis, caries, or other chronic severe pain conditions. Participants must be able to use smart devices and complete study activities without assistance.Check my eligibility
What is being tested?
The study tests the effects of a desensitizing toothpaste containing stannous fluoride on oral health quality of life in people with dentin hypersensitivity. It aims to gather real-world data on managing this condition through daily treatment.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include allergic reactions or increased tooth sensitivity if intolerance to stannous fluoride or any ingredients in the toothpaste exists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
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I can use my smartphone or tablet for all required activities on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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 DHEQ Adaptation Domain Score (Q5-16) at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline in DHEQ Emotional Impact Domain (Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline in DHEQ Identity Domain (Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
+3 more
Secondary outcome measures
Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline in Global Oral Health (Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline in Impact on Everyday Life (Section 1, Q1-3) at Weeks 4, 8, 12, 16, 20 and 24
+4 more

Side effects data

From 2016 Phase 4 trial • 197 Patients • NCT02923895
1%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Test Dentifrice
Control Dentifrice

Trial Design

1Treatment groups
Experimental Treatment
Group I: Anti-sensitivity toothpasteExperimental Treatment1 Intervention
Participants will use the anti-sensitivity toothpaste according to the instructions on the commercial pack and their normal oral healthcare habits for 24 weeks.

Find a Location

Who is running the clinical trial?

HALEONLead Sponsor
27 Previous Clinical Trials
3,200 Total Patients Enrolled

Frequently Asked Questions

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

Can those aged 75 years or older participate in this clinical study?

"This clinical trial has specified that participants must range from 18 to 65 years old. For those younger and older, respectively, there are 89 trials for minors and 177 studies catering specifically to seniors."

Answered by AI

How many test subjects are presently enrolled in this research project?

"Affirmative. According to clinicaltrials.gov, this research initiative is still searching for participants and was initially published on September 21st 2023 with the latest update issued October 6th of the same year. This trial requires 500 individuals from a single medical centre."

Answered by AI

Are there any vacancies left in this clinical trial?

"Affirmative. Clinicaltrials.gov states that this clinical trial, which was posted on September 21st 2023, is currently looking for 500 participants at 1 site. The details have been updated as of October 6th 2023."

Answered by AI

Am I eligible to participate in this scientific experiment?

"This medical trial is enrolling 500 volunteers aged between 18 and 65 who suffer from tooth sensitivity. To be eligible, participants must willingly give consent for the study, have the capacity to complete tasks on their own with smart devices, as well as attest to experiencing symptoms of tooth discomfort."

Answered by AI

What are the key goals of this research endeavor?

"The primary objective for this medical trial, which will be evaluated at Baseline and Weeks 4, 8, 12, 16, 20 & 24 is to assess the transformation in DHEQ Identity Domain (Q30-34) Score. Secondary goals include monitoring change from baseline with regards to Numeric Pain Rating Scale (NPRS) outcomes at Weeks 1, 2 ,4 ,8 ,12 ,16,,20 & 24; Satisfaction Numeric Rating Scale (NRS) Score at Week 24; and Global Oral Health (Section 2 Q35) score during the same intervals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management
2023. "A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045026.
~0 spots leftby May 2024
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