Experimental Toothpaste for Tooth Decay
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that certain medications like antibiotics and bisphosphonates should not be taken before or during the study. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment Test Dentifrice for tooth decay?
Is the experimental toothpaste safe for humans?
How is the experimental toothpaste for tooth decay different from other treatments?
What is the purpose of this trial?
The aim of this study is to evaluate the relative efficacy of an experimental dentifrice containing 1150 parts per million (ppm) fluoride (as sodium fluoride \[NaF\]) to remineralize early stage caries type lesions in an in situ model compared to a negative control and a reference dentifrice.
Eligibility Criteria
This trial is for individuals aged 18-85 with normal saliva flow and good overall health, who can follow the study schedule and procedures. They must not be pregnant, breastfeeding, or planning to become pregnant. People with recent substance abuse history, on certain medications like antibiotics or blood thinners, or with dental issues affecting the study are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants use the assigned dentifrice for 14 days to assess remineralization of early stage caries lesions
Washout Period 1
Participants use a washout dentifrice for 2-3 days before the next treatment period
Treatment Period 2
Participants use the assigned dentifrice for 14 days to assess remineralization of early stage caries lesions
Washout Period 2
Participants use a washout dentifrice for 2-3 days before the next treatment period
Treatment Period 3
Participants use the assigned dentifrice for 14 days to assess remineralization of early stage caries lesions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Test Dentifrice
Find a Clinic Near You
Who Is Running the Clinical Trial?
HALEON
Lead Sponsor