Fluoride Rinse for Oral Health
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a new fluoride mouth rinse on children's oral health. It compares using only a toothbrush with using a toothbrush plus a special mouth rinse containing essential oils, and another with a known fluoride rinse. The goal is to assess how these different methods impact oral health over a month. Children aged 6-11 with at least 16 natural teeth, good oral health, and the ability to follow instructions may be suitable for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to important research on improving children's oral health.
Will I have to stop taking my current medications?
You may need to stop taking certain medications before joining the trial. Specifically, you cannot use antibiotics, anticoagulants, immunosuppressive drugs, steroids, non-steroidal anti-inflammatory drugs, or antihistamines within specific time frames before the study starts.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Past research has found fluoride varnishes to be safe for children, reducing cavities without causing fluorosis, a condition that affects teeth. This indicates that fluoride treatments are generally safe. The Jolly Rancher Prototype rinse aims to avoid mouth irritation. Although specific safety data is not yet available, the focus on gentleness ensures careful testing.
In contrast, LISTERINE Total Care Zero Alcohol rinse is already available in stores and is known to be safe. It contains no alcohol and helps prevent cavities while freshening breath. Its long market presence provides a strong safety record. Overall, both treatments appear well-tolerated, with the LISTERINE rinse having more established safety due to its availability.12345Why are researchers excited about this trial?
Researchers are excited about the fluoride rinse treatments being tested for oral health because they introduce new, potentially more appealing options for maintaining oral hygiene. One experimental rinse uses a Jolly Rancher flavor prototype, which could make the daily routine of mouth rinsing more enjoyable, especially for kids. Another experimental rinse utilizes LISTERINE® Total Care Zero Alcohol, offering a gentle option for those who prefer or require alcohol-free products. These innovations aim to increase compliance and effectiveness compared to traditional fluoride toothpastes and mouthwashes, potentially leading to better cavity prevention.
What evidence suggests that this trial's treatments could be effective for oral health?
Research shows that fluoride rinses can reduce cavities and improve children's oral health. Studies have found that using a fluoride mouth rinse prevents the loss of minerals from tooth enamel, which is crucial for maintaining strong teeth. Fluoride strengthens teeth and stops decay. In this trial, participants in the "Brush / Rinse (Jolly Rancher Prototype)" arm will use the Jolly Rancher Prototype rinse, expected to offer similar benefits due to its fluoride content. Participants in the "Brush / Rinse (LISTERINE® Total Care Zero Alcohol)" arm will use the LISTERINE Total Care Zero Alcohol rinse, which has been proven to fight cavities and kill germs, aiding in good oral hygiene. Evidence supports that both treatments can improve dental health in children.36789
Are You a Good Fit for This Trial?
This trial is for healthy children aged 6-11 with good oral hygiene, at least 16 natural teeth, and no significant dental issues. They must understand the study and agree to participate along with parental consent. The study aims for diversity including a minimum percentage of Black, Asian, and Hispanic participants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the assigned mouth rinse or brushing regimen for oral tissue tolerance assessment over a four-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fluoride Rinse
Trial Overview
The trial tests the safety of an experimental fluoride mouth rinse compared to brushing alone and a commercial mouthwash (LISTERINE® Total Care Zero Alcohol). Over four weeks, kids will follow assigned oral care routines to assess tissue tolerance in their mouths.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (LISTERINE® Total Care Zero Alcohol).
All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (Jolly Rancher Prototype).
All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johnson & Johnson Consumer and Personal Products Worldwide
Lead Sponsor
Joaquin Duato
Johnson & Johnson Consumer and Personal Products Worldwide
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Johnson & Johnson Consumer and Personal Products Worldwide
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
Determination of the Oral Irritation Potential of a Fluoride ...
Determination of the Oral Irritation Potential of a Fluoride Rinse in Children. ClinicalTrials.gov ID NCT06798441. Sponsor Johnson & Johnson Consumer and ...
2.
ctv.veeva.com
ctv.veeva.com/study/determination-of-the-oral-irritation-potential-of-a-fluoride-rinse-in-childrenDetermination of the Oral Irritation Potential of a Fluoride ...
The primary objective of this clinical trial is to determine the oral hard and soft tissue tolerance of an investigational essential oil, ...
Effectiveness of fluoride mouthrinse in prevention ...
This review concluded that rinsing with FLR in the course of the fixed orthodontic treatment lessens demineralization around the bracket.
4.
news-medical.net
news-medical.net/news/20250919/CHOP-researchers-unveil-framework-for-boosting-childrens-oral-health.aspxCHOP researchers unveil framework for boosting children's ...
Dental fluoride varnish is a safe and effective procedure used to reduce the risk of cavities in children with no risk of fluorosis. Despite ...
Quality Measure Adherence and Oral Health Outcomes in ...
A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children.
Determination of the Oral Irritation Potential of a Fluoride ...
The primary objective of this clinical trial is to determine the oral hard and soft tissue tolerance of an investigational essential oil, non-alcohol, fluoride ...
In vitro enamel erosion associated with commercially ...
This concentration is roughly equivalent to 1 Jolly Rancher® per oz or 1 Twizzlers® per 2.5 oz. The composition of the inorganic, artificial saliva was 20mM ...
FLUORIDATION: DILEMMA
... Fluoride Toxicity. •••••• 98. Dental and Skeletal Fluorosis, 98. Soft Tissue. Organs, 104. Fatalities, 104. Narrow Margin of. Safety, 107. References, 108 ...
9.
analyticalsciencejournals.onlinelibrary.wiley.com
analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/jlcr.3725Poster Presentations - Analytical Science Journals - Wiley
Fluorination of these compounds from an excess of four different fluoride salts has shown a moderate conversion in aryl fluoride of around 10% ...
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