Experimental Toothpaste for Tooth Decay

Overseen By Haleon Response Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HALEON

Must not be taking: Antibiotics, Bisphosphonates, Fluoride supplements

Disqualifiers: Pregnancy, Substance abuse, Active caries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

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

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

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

Group I: Test Dentifrice Experimental Treatment 1 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 Dentifrice Active Control 1 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 Dentifrice Active Control 1 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.

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effect of commercial fluoride dentifrices against hydrochloric acid in an erosion-abrasion model. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Ultrasonic measurement of dentin remineralization effects of dentifrices and silver diamine fluoride. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Importance of bioavailable calcium in fluoride dentifrices for enamel remineralization. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of High-Fluoride Dentifrice on Enamel Erosion Adjacent to Restorations In Vitro. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Clinical investigation of the effects of dentifrices on dentin wear at the cementoenamel junction. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Exploratory Randomized Clinical Trial of an Experimental Gel-to-Foam Fluoride Dentifrice Formulation Using an In Situ Caries Model. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Cariostatic effect of a two-part fluoride dentifrice in rats. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Recommendation for a non-animal alternative to rat caries testing. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of desensitizing toothpastes on dentin erosive wear and tubule occlusion. An in situ study. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

In vitro assessments of experimental NaF dentifrices containing a prospective calcium phosphate technology. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Comparison of the effect of fluoride and non-fluoride dentifrices on enamel demineralization and remineralization in vitro]. [2014]

12. Germany pubmed.ncbi.nlm.nih.gov

Inhibition Effects of Different Toothpastes on Demineralisation of Incipient Enamel Lesions. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

New laboratory methods to study tooth surface coverage and interproximal plaque control by dentifrice products. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

Anticaries efficacy of a new dentifrice for hypersensitivity. [2012]

15. England pubmed.ncbi.nlm.nih.gov

Effects of child formula dentifrices on artificial caries like lesions using in vitro pH-cycling: preliminary results. [2019]