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Fluoride-containing Dentifrice

Experimental Dentifrice for Tooth Decay

N/A

Waitlist Available

Research Sponsored by HALEON

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is between the ages of 18-65 years

Participant in good general and mental health with no clinically significant abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4 and 12 hours of intra-oral exposure

Awards & highlights

Study Summary

This trial aims to test a new toothpaste with fluoride to see if it can help strengthen weakened enamel and prevent further damage compared to a fluoride-free toothpaste and a standard fluoride toothpaste.

Who is the study for?

This trial is for adults aged 18-65 with good overall and oral health, who can follow the study plan. They must not work at the study site or have used investigational products in the last month. Those with dry mouth from medication, braces, severe dental issues, or are pregnant/breastfeeding cannot join.Check my eligibility

What is being tested?

The study tests an experimental toothpaste with fluoride (1150 ppm) against a placebo without fluoride and a known fluoride toothpaste. It aims to see if it's better at rebuilding enamel and preventing further decay.See study design

What are the potential side effects?

Since all products are dentifrices (toothpastes), side effects may include irritation of the gums or mouth, allergic reactions to ingredients, or possibly no significant side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am in good physical and mental health with no major health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4 and 12 hours of intra-oral exposure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4 and 12 hours of intra-oral exposure

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 and 12 hours of intra-oral exposure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Surface Microhardness Recovery (%SMHR) at 4 Hours (Experimental Dentifrice Versus (vs.) Placebo Dentifrice)

Secondary outcome measures

%RER at 12 hours

%RER at 4 and 12 hours (Reference Dentifrice vs Placebo Dentifrice)

%RER at 4 hours (Experimental Dentifrice vs. Reference Dentifrice)

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Experimental DentifriceExperimental Treatment1 Intervention

Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 grams (g) of the experimental dentifrice containing 1150 ppm fluoride and 5 percent (%) potassium nitrate (KNO3) for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.

Group II: Reference DentifriceActive Control1 Intervention

Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the reference dentifrice containing 1100 ppm fluoride as stannous fluoride (SnF2) for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.

Group III: Placebo Control DentifricePlacebo Group1 Intervention

Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the placebo dentifrice containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Experimental Dentifrice

2022

N/A

~120

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

HALEONLead Sponsor

29 Previous Clinical Trials

4,134 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial include individuals who are above the age of 50?

"As indicated in the study's eligibility criteria, individuals aged 18 and above but below 65 are eligible for participation."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"As per clinicaltrials.gov, recruitment for this specific trial is currently closed. Initially shared on 2/26/2024 and last revised on 1/29/2024, the study is not actively seeking participants. However, it's worth noting that there are five alternative trials presently open to new enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel

2024. "An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242444.

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