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Special Ingredient Toothpaste for Maintaining Tooth Whiteness After Bleaching
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
Participant is of either sex and any gender who, at the time of screening, is between the ages of 18-65 years, inclusive
Participant who is willing and able to undergo at-home tooth bleaching with peroxide containing treatment unsupervised
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 12 and week 24 after tooth bleaching
Awards & highlights
Study Summary
This trial tests a toothpaste with special ingredients to reduce tooth discoloration after bleaching and maintain whiteness.
Who is the study for?
This trial is for adults aged 18-65 with good general and oral health, who can perform at-home tooth bleaching. They must be able to follow the study's schedule and procedures. Excluded are those with recent dental treatments, known sensitivities to study materials, pregnant or breastfeeding individuals, substance abuse history, certain dental conditions like braces or severe cavities.Check my eligibility
What is being tested?
The study tests an experimental dentifrice containing potassium nitrate, alumina, and sodium tripolyphosphate against a regular fluoride toothpaste (Aquafresh). It aims to see if the new formula better maintains tooth color and reduces stains after bleaching compared to the standard option.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include increased tooth sensitivity or mild irritation of gums due to ingredients in both test and reference dentifrices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I am willing and able to use a peroxide-based tooth bleaching treatment at home without supervision.
Select...
I am in good physical and mental health with no significant medical history.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 12 and week 24 after tooth bleaching
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12 and week 24 after tooth bleaching
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean VITA Shade Score at 24 Weeks After Tooth Bleaching
Secondary outcome measures
Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching
Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching
Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Test DentifriceExperimental Treatment1 Intervention
Participants will dose the toothbrush provided with a strip of test dentifrice (5% KNO3, 1% alumina, 5% STP and 1150 parts per million [ppm] fluoride as sodium fluoride) and will brush for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice will be used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants will perform the first application of peroxide tooth bleaching as per the instructions provided and continue the application daily for up to 7 days.
Group II: Reference DentifriceActive Control1 Intervention
Participants will dose the toothbrush provided with a strip of reference dentifrice (dentifrice containing 1150 ppm fluoride as sodium fluoride) and will brush for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice will be used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants will perform the first application of peroxide tooth bleaching as per the instructions provided and continue the application daily for up to 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Test Dentifrice
2015
N/A
~30
Find a Location
Who is running the clinical trial?
HALEONLead Sponsor
27 Previous Clinical Trials
3,576 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is within the scope of this medical experiment's recruitment?
"An individual must meet the age criteria of 18-65 and have appropriate oral hygiene to be considered for this clinical trial. This study plans on recruiting a total of 160 patients."
Answered by AI
Does this research offer enrollment to individuals who are more mature?
"This medical study is open to those aged 18 and over, but not exceeding 65 years."
Answered by AI
Are new participants still allowed to join this research project?
"Contrary to expectation, clinicaltrials.gov informs us that this medical trial is not accepting any more patients at the present moment. The study was first listed on November 27th 2023 and had its last update a few days later on November 21st 2023. Fortunately, 17 other trials are actively recruiting participants right now."
Answered by AI
Who else is applying?
What site did they apply to?
Silverstone Research Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
Want to be compensated, interested to try tooth whitening.
PatientReceived 2+ prior treatments
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