Experimental Toothpaste for Gum Disease

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new toothpaste containing stannous fluoride to determine if it improves gum health and reduces plaque more effectively than regular fluoride toothpaste. Participants will use either the experimental toothpaste or a regular one for 24 weeks. The trial seeks individuals with mild to moderate gum disease who do not smoke or have severe oral conditions that could affect the results. As an unphased trial, this study offers an opportunity to contribute to dental health research and potentially benefit from an innovative toothpaste.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stannous fluoride, the main ingredient in the experimental toothpaste, is generally safe in dental products. Studies have found it effectively reduces plaque and improves gum health with few side effects. Some individuals might notice mild tooth staining, but this is usually harmless and can often be cleaned by a dentist.

Stannous fluoride is already present in many regular toothpastes, providing strong evidence for its safe use in oral health. However, as with any new product, monitoring for any unusual reactions is important.

In summary, the experimental toothpaste with stannous fluoride has a history of safe use in similar products, suggesting it should be well-tolerated by most people.

Why are researchers excited about this trial's treatment?

Most treatments for gum disease focus on reducing bacteria and inflammation, often using standard toothpaste with fluoride and other antimicrobial agents. However, the experimental toothpaste in this trial stands out because it may contain a novel active ingredient designed to target and reduce gum inflammation more effectively. Researchers are excited because this new ingredient could offer a more efficient way to improve gum health and prevent disease progression. By potentially providing enhanced anti-inflammatory properties, this toothpaste might address some of the limitations of current options, offering a promising alternative for those struggling with gum disease.

What evidence suggests that this trial's treatments could be effective for gum disease?

Research has shown that new toothpastes containing ingredients like stannous fluoride and enzymes can greatly improve gum health. In studies, these toothpastes effectively reduced gingivitis, which is gum inflammation. They lowered plaque, the sticky buildup of bacteria, and improved overall gum health compared to regular fluoride toothpaste. For instance, one study found that using a toothpaste with these active ingredients significantly reduced signs of gum disease. In this trial, participants will use either the Test Dentifrice, the experimental toothpaste, or one of the Reference Dentifrices as a control. This suggests that the new toothpaste could effectively manage mild to moderate gingivitis.12345

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate gingivitis who are interested in testing the effectiveness of a new toothpaste designed to improve gum health and reduce plaque. Specific eligibility details were not provided, so general oral health conditions may apply.

Inclusion Criteria

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, treatment plan, and other study procedures
Participant must be in good general and mental health with no clinically significant abnormalities that would impact safety or study outcomes
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Exclusion Criteria

Participant with recent history of alcohol or substance abuse
Participant who is an employee of the investigational site or their immediate family
Participant who has participated in other studies involving investigational products within 30 days prior to study entry or during study participation
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants brush their teeth with assigned dentifrice twice daily for 24 weeks

24 weeks
Visits at Weeks 1, 4, 12, and 24 for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Experimental Toothpaste
Trial Overview The study compares an experimental toothpaste containing Stannous fluoride (SnF2) against regular fluoride toothpaste over 24 weeks. It aims to see if the new formula is better at improving gum health and preventing plaque buildup.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Test DentifriceExperimental Treatment1 Intervention
Group II: Reference Dentifrice (Positive Control)Active Control1 Intervention
Group III: Reference Dentifrice (Negative Control)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials
40
Recruited
6,000+

Citations

Efficacy of an experimental toothpaste containing sodium ...Conclusions. Both the experimental and the positive control toothpastes demonstrated clinically relevant improvements in gingival health ...
NCT07255040 | A Clinical Study to Evaluate the ...The aim of this 24-week clinical study is to evaluate the ability of an experimental dentifrice containing 0.454 percent (%) weight by weight (w/w) Stannous ...
A randomised clinical trial to determine the effect of a ...The test toothpaste containing enzymes and proteins demonstrated significant plaque and gingival benefit compared to the control toothpaste, and was well ...
Efficacy of toothpaste containing OPTIMEALTH® OR in...Collectively, we observed a notable decrease in the clinical indices (PI and BOP%) among the subjects who were using the OPTIMEALTH® OR toothpaste. 3.3. 16s ...
The effect of enzyme and protein containing toothpaste on ...Conclusion The study demonstrated that a toothpaste containing naturally occurring enzymes and proteins significantly improved gingival health ...
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