50 Participants Needed

Experimental Toothpaste for Tooth Decay

HR
Overseen ByHaleon Response Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that fluoride dentifrices (toothpastes) can help protect teeth from acid damage and aid in rebuilding tooth enamel, which suggests that Test Dentifrice might also be effective in preventing tooth decay.12345

Is the experimental toothpaste safe for humans?

The safety of the experimental toothpaste was evaluated in a study comparing it to a currently marketed toothpaste, and it was found to be safe in that context.678910

How is the experimental toothpaste for tooth decay different from other treatments?

The experimental toothpaste is unique because it may contain stannous fluoride, which not only helps prevent cavities but also addresses tooth sensitivity, unlike many standard toothpastes that focus solely on cavity prevention.1112131415

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

Participant must demonstrate normal salivary flow-rate values
Participant must provide a signed and dated informed consent document before any assessment is performed
Participant must be willing and able to comply with scheduled visits, study procedures, and restrictions
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Exclusion Criteria

Participant who has previously been enrolled in this study
Participant who is an employee of the investigational site or a Haleon employee directly involved in the study
Participant who has participated in other studies involving investigational products within 30 days prior to study entry
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants use the assigned dentifrice for 14 days to assess remineralization of early stage caries lesions

2 weeks
Off-site product use, specimens removed at study site

Washout Period 1

Participants use a washout dentifrice for 2-3 days before the next treatment period

2-3 days

Treatment Period 2

Participants use the assigned dentifrice for 14 days to assess remineralization of early stage caries lesions

2 weeks
Off-site product use, specimens removed at study site

Washout Period 2

Participants use a washout dentifrice for 2-3 days before the next treatment period

2-3 days

Treatment Period 3

Participants use the assigned dentifrice for 14 days to assess remineralization of early stage caries lesions

2 weeks
Off-site product use, specimens removed at study site

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Test DentifriceExperimental Treatment1 Intervention
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.
Group II: Reference DentifriceActive Control1 Intervention
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.
Group III: Negative Control DentifriceActive Control1 Intervention
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

Trials
40
Recruited
6,000+

References

Effect of commercial fluoride dentifrices against hydrochloric acid in an erosion-abrasion model. [2021]
Ultrasonic measurement of dentin remineralization effects of dentifrices and silver diamine fluoride. [2022]
Importance of bioavailable calcium in fluoride dentifrices for enamel remineralization. [2019]
Effect of High-Fluoride Dentifrice on Enamel Erosion Adjacent to Restorations In Vitro. [2019]
Clinical investigation of the effects of dentifrices on dentin wear at the cementoenamel junction. [2019]
Exploratory Randomized Clinical Trial of an Experimental Gel-to-Foam Fluoride Dentifrice Formulation Using an In Situ Caries Model. [2015]
Cariostatic effect of a two-part fluoride dentifrice in rats. [2013]
Recommendation for a non-animal alternative to rat caries testing. [2022]
Effect of desensitizing toothpastes on dentin erosive wear and tubule occlusion. An in situ study. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
In vitro assessments of experimental NaF dentifrices containing a prospective calcium phosphate technology. [2022]
[Comparison of the effect of fluoride and non-fluoride dentifrices on enamel demineralization and remineralization in vitro]. [2014]
Inhibition Effects of Different Toothpastes on Demineralisation of Incipient Enamel Lesions. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
New laboratory methods to study tooth surface coverage and interproximal plaque control by dentifrice products. [2013]
14.United Statespubmed.ncbi.nlm.nih.gov
Anticaries efficacy of a new dentifrice for hypersensitivity. [2012]
Effects of child formula dentifrices on artificial caries like lesions using in vitro pH-cycling: preliminary results. [2019]
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