Experimental Toothpaste for Tooth Sensitivity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two new toothpastes, Test Toothpaste 1 and Test Toothpaste 2, to determine their effectiveness in reducing tooth sensitivity and whitening teeth. Participants will use one of the experimental toothpastes or a reference toothpaste, brushing twice daily for 8 weeks. Ideal candidates have experienced tooth sensitivity for over six months, maintain good oral health, and have at least 20 natural teeth. As an unphased trial, this study allows participants to contribute to innovative dental care research and potentially experience new benefits firsthand.
Will I have to stop taking my current medications?
The trial may require you to stop taking certain medications if they could interfere with your perception of tooth sensitivity, such as pain relievers or mood-altering drugs. It's best to discuss your current medications with the study team to see if any changes are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Test Toothpaste 1 and Test Toothpaste 2 are undergoing safety tests for people with sensitive teeth. Previous studies have found that similar toothpastes are usually well-tolerated and help with sensitivity without causing major problems. Users of these toothpastes have not reported serious side effects.
Some studies have examined ingredients like stannous fluoride, often used to reduce tooth sensitivity, and have not found any serious negative reactions.
For those considering joining the trial, evidence suggests these new toothpastes have been generally safe in past research. However, since testing continues, staying informed and discussing any concerns with a healthcare provider is advisable.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these experimental toothpastes for tooth sensitivity because they may offer new solutions for those suffering from this common dental issue. Unlike traditional treatments that often rely on potassium nitrate or stannous fluoride to block nerve signals or strengthen enamel, these new toothpastes might use different active ingredients or mechanisms to target sensitivity more effectively. Test Toothpaste 1 and Test Toothpaste 2 promise a fresh approach to managing sensitivity by potentially providing faster relief or longer-lasting protection for sensitive teeth.
What evidence suggests that this trial's toothpastes could be effective for tooth sensitivity?
Research shows that both Test Toothpaste 1 and Test Toothpaste 2, studied in this trial, effectively reduce dentin hypersensitivity, the pain felt in teeth from hot, cold, or sweet foods. Participants will use either Test Toothpaste 1 or Test Toothpaste 2. Studies have found that Test Toothpaste 1 can lower sensitivity by 26-29% after two weeks and up to 40% after four weeks. Test Toothpaste 2 also significantly reduces sensitivity with regular use. Both toothpastes contain ingredients like 3% PVM/MA and 5% KNO3, which help with sensitivity by blocking tiny channels in teeth that cause pain. Overall, previous studies suggest these toothpastes are promising in easing tooth sensitivity.13467
Are You a Good Fit for This Trial?
This trial is for individuals with tooth sensitivity and hypersensitive dentin who are seeking teeth whitening. Participants should have a certain level of tooth shade and dental stains suitable for evaluating the effectiveness of whitening toothpastes.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use assigned toothpaste twice daily for 8 weeks to assess tooth whitening and dentin hypersensitivity efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Test Toothpaste 1
- Test Toothpaste 2
Trial Overview
The study is testing two experimental toothpastes against a reference one to see which is better at whitening teeth and reducing dentin hypersensitivity. It's an exploratory study, meaning it's preliminary research into these products' performance.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will be instructed to brush the entire dentition thoroughly using Test toothpaste 2 for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth.
Participants will be instructed to brush the entire dentition thoroughly using Test toothpaste 1 for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth.
Participants will be instructed to brush the entire dentition thoroughly using Reference toothpaste for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth.
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Who Is Running the Clinical Trial?
HALEON
Lead Sponsor
Citations
A Study to Investigate the Tooth Whitening and Dentin ...
The aim of this exploratory clinical study is to investigate the tooth whitening potential, Dentin Hypersensitivity (DH) efficacy, ...
A randomized clinical trial for comparing the efficacy of ...
In the acidic sensitivity test, all groups showed a significant reduction in DH, especially with longer duration of toothpaste usage (0โ2 week, ...
An exploratory randomised controlled clinical trial to ...
The Test toothpaste containing 3% PVM/MA + 5% KNO3 was superior to the other 3 toothpaste treatments in reducing DH at all time points for both ...
Effectiveness of Bioactive Toothpastes against Dentin ...
According to these results, it can be observed that all toothpastes were effective in controlling pain resulting from tooth hypersensitivity, ...
New toothpaste to deal with dentine hypersensitivity
Results: A significant reduction in dentine hypersensitivity (26-29% after 2 weeks versus 40% after 4 weeks) was detected in the tested group. The controls also ...
Products for the Management of Dentinal Hypersensitivity
If the product contains ingredients not on the generally recognized as safe (GRAS) list, a 6-month safety study may be required. See Appendix for details. 4.
A study to investigate the effect of a sensitivity toothpaste ...
The aim of this study is to investigate the ability of an experimental stannous fluoride toothpaste in providing relief from tooth sensitivity following a ...
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