Mouthwash for Gum Disease

Overseen By Haleon Response Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HALEON

Must not be taking: Antibiotics, Anti-inflammatories, Anticoagulants, others

Disqualifiers: Pregnancy, Breastfeeding, Smoking, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether an experimental mouthwash can improve gum health and reduce plaque when used with regular toothbrushing and fluoride toothpaste. It compares the effects of using only the toothpaste versus using both the toothpaste and the mouthwash. Individuals with mild to moderate gingivitis caused by plaque and at least 20 natural teeth may be suitable for this study. As an unphased trial, this study offers a chance to contribute to valuable research that could enhance oral health practices.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot take antibiotics, anti-inflammatory drugs, or certain other medications that could affect your gum health for at least 4 weeks before the study starts. It's best to discuss your current medications with the study team to see if any changes are needed.

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

Research has shown that cetylpyridinium chloride (CPC), the main ingredient in the experimental mouthwash, is usually well-tolerated. Studies have found that mouthwashes containing CPC can reduce plaque and improve gum health. CPC is also present in other mouthwash products already on the market, indicating its safety.

Some individuals have reported minor side effects, such as a temporary change in taste or slight mouth irritation, but these effects are generally mild and resolve on their own. There is no strong evidence of serious side effects from using CPC mouthwashes. Participants should consider this information when deciding to join the trial.

Why are researchers excited about this trial?

Researchers are excited about the experimental mouthwash for gum disease because it offers a potential new way to tackle this common issue. Unlike standard treatments that typically rely on regular toothpaste or medically prescribed rinses, this mouthwash is designed to be used in conjunction with toothpaste, providing an additional layer of oral care. After brushing, participants swish the mouthwash for 30 seconds without rinsing, which could enhance the effectiveness by allowing active ingredients to remain in contact with the gums longer. This approach targets gum disease directly at the site, potentially offering improved outcomes compared to conventional methods.

What evidence suggests that this mouthwash could be effective for gum disease?

Research has shown that Cetylpyridinium chloride (CPC), the main ingredient in the experimental mouthwash tested in this trial, can help reduce plaque and improve gum health. Studies have found that mouthwashes with CPC significantly lower dental plaque and gingivitis, which is gum inflammation. CPC effectively breaks up the bacteria that form plaque, leading to healthier gums over time. Participants in this trial will use the CPC mouthwash along with regular brushing, and early results suggest this combination improves oral hygiene more than brushing alone. While more research is always helpful, CPC is already recognized as a beneficial ingredient for promoting oral health.

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate gingivitis, which is gum inflammation often caused by plaque buildup. Participants should be experiencing some level of gum disease and oral plaque. The study requires them to use a specific fluoride toothpaste along with the experimental mouthwash or just the toothpaste alone.

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 study procedures

Participant must be in good general and mental health with no clinically significant abnormalities that would impact safety or study outcomes

Exclusion Criteria

Participant who has previously been enrolled in the study

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the experimental mouthwash containing 0.085% CPC in combination with a regular fluoride toothpaste for 12 weeks

12 weeks

Regular visits for assessments at Week 6 and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Experimental Mouthwash

Trial Overview The study tests if an experimental mouthwash containing 0.085% Cetylpyridinium chloride (CPC) can improve gum health and reduce plaque when used alongside regular brushing with Crest Cavity Protection Toothpaste, compared to using the toothpaste alone over a period of 12 weeks.

How Is the Trial Designed?

Group I: Test Products (Toothpaste + Mouthwash) Experimental Treatment 2 Interventions

Participants will be instructed to brush their teeth with the toothpaste (Crest Cavity Protection) for at least one minute twice daily (morning and evening) for 12 weeks. After each brushing, participants will swish 20 milliliter (ml) of experimental mouthwash for 30 seconds without rinsing with water after use of mouthwash.

Group II: Reference Product (Toothpaste) Active Control 1 Intervention

Participants will be instructed to brush their teeth with the toothpaste (Crest Cavity Protection) for at least one minute twice daily (morning and evening) for 12 weeks.

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+

Citations