Experimental Toothpaste for Tooth Decay
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how effectively a new toothpaste can repair early signs of tooth decay. It compares the experimental toothpaste, Test Dentifrice, which contains fluoride, to a regular toothpaste and one without active ingredients. Individuals who wear a removable lower partial denture and are willing to adjust it for the study may be suitable candidates. Participants will brush their teeth with the provided toothpaste and follow specific instructions for short periods. As an unphased trial, this study allows participants to contribute to dental health research and potentially benefit from innovative oral care solutions.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that fluoride toothpaste, like the one in this trial, is generally safe for use. People commonly use fluoride toothpaste to prevent cavities. Although most fluoride toothpaste has not undergone extensive clinical testing, it meets the basic safety standards set by the FDA.
The fluoride level in this experimental toothpaste is similar to many other products available in stores, suggesting it is likely well-tolerated by most people. No known reports of serious side effects exist from using toothpaste with 1150 parts per million (ppm) fluoride, the amount used in this study. However, it is important to use the product as directed and monitor for any unusual reactions, such as irritation or an allergic response.
In summary, the experimental toothpaste in this trial is expected to be as safe as regular fluoride toothpaste.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this experimental toothpaste for tooth decay because it introduces a novel approach to oral care. Unlike standard toothpastes that often contain fluoride as the primary active ingredient, this test dentifrice may incorporate a new active ingredient designed to enhance protection against cavities more effectively. Additionally, this toothpaste could offer quicker benefits, showing potential results in as little as two weeks, compared to conventional options that might take longer to demonstrate significant improvements. The innovative formula and rapid action are why this treatment stands out in the fight against tooth decay.
What evidence suggests that this trial's treatments could be effective for tooth decay?
Research has shown that fluoride in toothpaste helps prevent tooth decay. One study found that toothpaste with 1,500 parts per million (ppm) of fluoride reduced cavities more effectively than toothpaste with less fluoride. Another study discovered that toothpaste with 1,100 ppm fluoride works as well as those with other ingredients, like nanohydroxyapatite, in preventing cavities. This trial will test a toothpaste with 1,150 ppm fluoride, which could effectively repair early-stage cavities. Overall, fluoride toothpaste is a proven way to maintain healthy teeth.46789
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Test Dentifrice
Trial Overview
The study tests an experimental toothpaste containing fluoride against a negative control (placebo) and a reference toothpaste to see if it's better at repairing early stage cavities. Participants will use these products in a controlled setting to compare their effectiveness.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will be instructed to dose the toothbrush provided with a strip of test dentifrice (a full brush head) and brush for one timed minute, twice daily (morning and evening) per the Brushing Instructions for up to 14 days each in Treatment Periods 1 to 3 as per crossover assignment. There will be a washout period of 2-3 days prior to each treatment period during which the participants will brush their teeth with the washout dentifrice for one timed minute, twice daily (morning and evening) per the Brushing Instructions.
Participants will be instructed to dose the toothbrush provided with a strip of reference dentifrice (a full brush head) and brush for one timed minute, twice daily (morning and evening) per the Brushing Instructions for up to 14 days each in Treatment Periods 1 to 3 as per crossover assignment. There will be a washout period of 2-3 days prior to each treatment period during which the participants will brush their teeth with the washout dentifrice for one timed minute, twice daily (morning and evening) per the Brushing Instructions.
Participants will be instructed to dose the toothbrush provided with a strip of negative control dentifrice (a full brush head) and brush for one timed minute, twice daily (morning and evening) per the Brushing Instructions for up to 14 days each in Treatment Periods 1 to 3 as per crossover assignment. There will be a washout period of 2-3 days prior to each treatment period during which the participants will brush their teeth with the washout dentifrice for one timed minute, twice daily (morning and evening) per the Brushing Instructions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
HALEON
Lead Sponsor
Citations
Effectiveness of Organic and Inorganic Fluoridated ...
The overall study results showed that the mean chance to avoid new cavities was high in organic fluoride dentifrice compared to inorganic ...
Evaluation of the Efficacy of a Dentifrice Tablet to Prevent ...
Conclusions: The present study demonstrated that dentifrice tablets containing 5% nanohydroxyapatite are as effective as NaF toothpastes containing 1100 ppm ...
Effectiveness of Bioactive Glass-Based Toothpaste for ...
The primary outcomes were caries increment, measured as changes in decayed, missing, and filled teeth (dmft) and surfaces (dmfs) scores, and caries incidence ...
4.
ada.org
ada.org/about/press-releases/community-water-fluoridation-is-effective-at-preventing-cavitiesCommunity Water Fluoridation is Effective at Preventing ...
Studies show that community water fluoridation prevents at least 25% of tooth decay in children and adults throughout their life span.
Recommendations for Using Fluoride to Prevent and ...
Toothpaste containing 1,500 ppm fluoride has been reported to be slightly more efficacious in reducing dental caries in U.S. and European ...
A Clinical Study to Assess an Experimental Dentifrice in ...
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-Containing Dentifrices
Test reports must include total fluoride, heavy metals, pH, microbiology, abrasivity (specifically for dentin), stability, and readily fermentable carbohydrates ...
Dentifrices, mouthwashes, and remineralization/caries ...
However, the vast majority of currently marketed dentifrice products have not been clinically tested and have met only the minimal requirements of the FDA ...
Experimental Toothpaste for Tooth Decay
The aim of this study is to evaluate the relative efficacy of an experimental dentifrice containing 1150 parts per million (ppm) fluoride (as sodium ...
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