Stannous Fluoride Toothpaste + CPC 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: Cardiovascular diseases, Diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special mouthwash with Cetylpyridinium Chloride (CPC) and a toothpaste with Stannous Fluoride (SnF2) can improve gum health and reduce plaque more effectively than regular fluoride toothpaste. Participants will use either the SnF2 toothpaste alone, the combination of SnF2 toothpaste with CPC mouthwash, or a regular fluoride toothpaste for comparison. The study seeks individuals with plaque-induced gingivitis who have at least 20 natural teeth and experience bleeding in 10% to 30% of their gum sites. As an unphased trial, it offers an opportunity to contribute to understanding how these products might enhance oral health.

Do I need to stop taking my current medications to join the trial?

Yes, you may need to stop certain medications. You cannot take antibiotics, anti-inflammatory drugs, anticoagulants, immunosuppressants, or certain herbal remedies within 4 weeks before the trial or during the study. Also, you cannot use antibacterial toothpaste or mouthwash that could affect plaque or gingivitis measurements.

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

Research has shown that toothpaste with Stannous Fluoride and mouthwash with Cetylpyridinium Chloride are generally safe for people. Studies have found that these ingredients help reduce dental plaque and gum problems like gingivitis. Since these products are already available in stores, they are considered safe for public use.

Feedback from past users indicates that side effects are rare and usually mild, such as slight mouth irritation. Most people tolerate these treatments well. Various studies support the safety of these ingredients, making them reliable choices for improving gum health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using stannous fluoride toothpaste combined with cetylpyridinium chloride (CPC) mouthwash for gum disease because this duo has a unique approach to oral care. Unlike standard treatments that might just focus on fluoride, this combo uses stannous fluoride, known for its antibacterial properties, alongside CPC, which targets harmful bacteria in the mouth. This two-step method not only strengthens teeth but also aggressively fights the bacteria that contribute to gum disease, potentially offering a more comprehensive solution. While traditional options often focus solely on cavity prevention, this treatment aims to tackle both tooth and gum health effectively.

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

This trial will evaluate the effectiveness of Stannous Fluoride toothpaste and Cetylpyridinium Chloride mouthwash in improving gum health. Studies have shown that Stannous Fluoride toothpaste effectively reduces gum swelling and bleeding, with noticeable improvements, such as less gum inflammation, in as little as two weeks. Research indicates that it helps reduce plaque, a major cause of gum disease. Similarly, Cetylpyridinium Chloride mouthwash has been proven to lower plaque and improve gum health. In this trial, participants in one arm will use both Stannous Fluoride toothpaste and Cetylpyridinium Chloride mouthwash together to enhance overall gum health by reducing plaque and inflammation. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with plaque-induced gingivitis, which means they have gum disease and a noticeable buildup of plaque on their teeth. Participants should be looking to improve their gum health.

Inclusion Criteria

Participant provision of a signed and dated informed consent document

Participant willing and able to comply with scheduled visits, treatment plan, and study procedures

Participant with specific oral health criteria at screening and baseline visits

Exclusion Criteria

Participant with known intolerance or hypersensitivity to study materials

Participant with specific medical conditions or disorders

Participant who is an employee of the investigational site or Haleon

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use SnF2 toothpaste and CPC mouthwash or control toothpaste twice daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cetylpyridinium Chloride Mouthwash
• Stannous Fluoride Toothpaste

Trial Overview The study compares the effectiveness of two oral care routines: one uses Stannous Fluoride Toothpaste with CPC Mouthwash, and the other uses Regular Fluoride Toothpaste alone. The goal is to see which routine is better at improving gum health and reducing plaque.

How Is the Trial Designed?

Group I: Toothpaste/Mouthwash (SnF2 Toothpaste followed by CPC Mouthwash) Experimental Treatment 2 Interventions

Participants will brush their teeth with full ribbon of test toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks. After each brushing, participants will swish 20 milliliters (mL) of the mouthwash containing CPC vigorously between teeth for 30 seconds twice daily (morning and evening) for 12 weeks.

Group II: Negative Control Toothpaste (Sodium Fluoride Toothpaste) Active Control 1 Intervention

Participants will brush their teeth with full ribbon of negative control toothpaste containing sodium fluoride on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks.

Group III: Reference Toothpaste (SnF2 Toothpaste) Active Control 1 Intervention

Participants will brush their teeth with full ribbon of reference toothpaste containing SnF2 on head of toothbrush provided for at least one (timed) minute twice daily (morning and evening) for 12 weeks.

Cetylpyridinium Chloride Mouthwash is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cetylpyridinium Chloride Mouthwash for:

• Gingivitis prevention
• Plaque reduction
• Halitosis treatment

Approved in European Union as CPC Mouthwash for:

• Gingivitis prevention
• Plaque reduction
• Halitosis treatment

Approved in Canada as Cetylpyridinium Chloride Mouthwash for:

• Gingivitis prevention
• Plaque reduction
• Halitosis treatment

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+

Published Research Related to This Trial

A 0.07% cetylpyridinium chloride (CPC) mouth rinse significantly reduced plaque accumulation and gingival inflammation in adults with moderate gingivitis over a 6-month period, showing a strong efficacy compared to a placebo.

The study involved 67 participants, and the CPC mouth rinse demonstrated a notable microbiological impact, particularly against the bacteria Prevotella intermedia, indicating its potential role in improving oral health when used alongside regular tooth cleaning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a new mouth rinse formulation based on 0.07% cetylpyridinium chloride in the control of plaque and gingivitis: a 6-month randomized clinical trial. Costa, X., Laguna, E., Herrera, D., et al.[2013]

In a 6-month study involving 143 participants, a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice significantly reduced gingivitis by 21.7%, gingival bleeding by 57.1%, and plaque by 6.9% compared to a negative control dentifrice.

The study found no adverse effects on oral tissues or tooth staining, indicating that the dentifrice is safe for use in preventing gingivitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice. Mankodi, S., Bartizek, RD., Winston, JL., et al.[2015]

In a seven-day clinical study with 43 participants, a mouthrinse containing 0.05% cetylpyridinium chloride (CPC) significantly reduced dental plaque build-up by 29.3% compared to a control mouthrinse without CPC.

The CPC mouthrinse provided effective protection against plaque for at least 12 hours after use, demonstrating its efficacy in maintaining oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride in preventing dental plaque. Lotufo, R., Calil, CM., Feng, HS., et al.[2022]

Incorporating 2.5% cetylpyridinium chloride (CPC) into orthodontic adhesive significantly enhanced its antimicrobial properties against Streptococcus mutans without compromising the material's strength, making it a promising option for reducing dental caries risk in patients with braces.

Higher concentrations of CPC (5.0% and 10.0%) did show antimicrobial activity but affected the adhesive's tensile strength, indicating that 2.5% is the optimal concentration for maintaining both efficacy and structural integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial properties of an orthodontic adhesive combined with cetylpyridinium chloride. Al-Musallam, TA., Evans, CA., Drummond, JL., et al.[2013]

Mouthrinses containing cetylpyridinium chloride (CPC) alone or in combination with sodium fluoride (TFR) showed significant antibacterial effects against oral bacteria, achieving over 3 log reductions in viable counts.

The addition of sodium fluoride did not enhance the antibacterial or anti-biofilm effects of CPC, indicating that both compounds can be effectively used together in mouthrinses for improved oral hygiene without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibacterial and anti-biofilm activity of mouthrinses containing cetylpyridinium chloride and sodium fluoride. Latimer, J., Munday, JL., Buzza, KM., et al.[2018]

In a six-week clinical study with 110 participants, a mouthrinse containing 0.05% cetylpyridinium chloride (CPC) significantly reduced dental plaque and gingivitis compared to a control mouthrinse, showing greater reductions in plaque index scores by 27.9% and gingival index scores by 19.8%.

The study demonstrated that the 0.05% CPC mouthrinse provides effective 12-hour protection against plaque and gingivitis, making it a beneficial addition to oral hygiene routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride to control established dental plaque and gingivitis. Silva, MF., dos Santos, NB., Stewart, B., et al.[2013]

In a study involving an active/placebo design over 6 weeks, both CPC mouthrinse and placebo showed significant reductions in plaque and gingivitis scores, indicating that rinsing before brushing may be beneficial overall.

However, there was no significant difference in effectiveness between the CPC mouthrinse and the placebo, raising questions about the additional benefits of using CPC for improving gingival health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a cetylpyridinium chloride prebrushing rinse as an adjunct to oral hygiene and gingival health. Moran, J., Addy, M.[2013]

The alcohol-free Crest Pro-Health Rinse containing 0.07% cetylpyridinium chloride (CPC) demonstrated over 99% effectiveness in killing bacteria associated with plaque and gingivitis in an in vitro study.

In a clinical trial with 55 participants, the CPC rinse showed a significant 25% reduction in plaque compared to a placebo, and its antiplaque effects were comparable to those of Listerine, making it a suitable option for patients sensitive to alcohol-based products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibacterial and antiplaque effects of a novel, alcohol-free oral rinse with cetylpyridinium chloride. Witt, J., Ramji, N., Gibb, R., et al.[2013]

The study demonstrated that an alcohol-free mouthwash containing 0.075% cetylpyridinium chloride (CPC) and 0.05% sodium fluoride (NaF) significantly reduced dental plaque and gingivitis after three and six months of use, with reductions of up to 78.5% in plaque severity.

In contrast, the control mouthwash with only 0.05% NaF showed increases in gingivitis and plaque scores, highlighting the superior efficacy of the CPC mouthwash in managing oral health over the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative investigation to evaluate the clinical efficacy of an alcohol-free CPC-containing mouthwash as compared to a control mouthwash in controlling dental plaque and gingivitis: a six-month clinical study on adults in San Jose, Costa Rica. Ayad, F., Prado, R., Mateo, LR., et al.[2013]

In a five-month study with 44 adults, toothpaste and mouthwash containing amine fluoride and stannous fluoride (AmF/SnF2) significantly reduced dental plaque and root-surface caries more effectively than sodium fluoride (NaF) products, with a 47.4% decrease in root caries compared to 10% in the NaF group.

Both AmF/SnF2 and NaF treatments led to significant reductions in gingivitis, as indicated by decreased sulcus-bleeding index values, although there was no significant difference in effectiveness between the two groups for this outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of amine fluoride (AmF)/stannous fluoride (SnF2) toothpaste and mouthwashes on dental plaque accumulation, gingivitis and root-surface caries. Bánóczy, J., Nemes, J.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5113089/

Cetylpyridinium chloride mouth rinses alleviate ... Oral rinses containing chemotherapeutic agents, such as cetylpyridinium chloride (CPC), can alleviate plaque-induced gingival infections.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06933368

NCT06933368 | A Clinical Study to Evaluate the Efficacy of ... The aim of this 12-week clinical study is to evaluate the ability of an experimental mouthwash, containing 0.085 percent (%) Cetylpyridinium chloride (CPC) ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/idh.12916

The Effect of Cetylpyridinium Chloride Compared to ... Aim To evaluate the effectiveness of cetylpyridinium chloride (CPC) and chlorhexidine (CHX) mouthwashes (MW) on plaque and gingivitis scores ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020653923004549

Antimicrobial Mouthwashes: An Overview of Mechanisms ... As described, there is abundant robust evidence supporting the antibacterial, antiplaque, and antigingivitis effects of CHX mouthwash,1 and the best available ...

5. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-022-02518-2

A randomized controlled trial to evaluate the effectiveness of a ... This single-center, randomized controlled trial aimed to determine the effectiveness of a novel, biofilm-disrupting, mouth rinse that combines Cetylpyridinium ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06660069?term=CETYLPYRIDINIUM%20AND%20FLUORIDE%20ION&rank=2

A Study to Evaluate the Efficacy of a Stannous Fluoride ... The aim of this study is to assess the ability of a marketed Cetylpyridinium Chloride (CPC) mouthwash alongside a marketed Stannous Fluoride (SnF2) ...

7. withpower.com withpower.com/trial/phase-dental-plaque-10-2024-15687

Stannous Fluoride Toothpaste + CPC Mouthwash for Gum Disease Yes, Cetylpyridinium Chloride Mouthwash and Stannous Fluoride Toothpaste are promising treatments for gum disease. They help reduce dental plaque and gingivitis ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1532338225000387

original article antiplaque and antigingivitis effects of a ... This study assessed the overall health outcome of using multiple forms: a stabilized stannous fluoride toothpaste, an enhanced cetylpyridinium chloride ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8037529/

Recent Development of Active Ingredients in Mouthwashes ... The common active ingredients in toothpastes and mouthwashes included in this review are chlorhexidine, cetylpyridinium chloride, sodium fluoride, stannous ...

10. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-of-a-stannous-fluoride-toothpaste-with-a-cetylpyridinium-chloride-m

A Study to Evaluate the Efficacy of a Stannous Fluoride ... The aim of this study is to assess the ability of a marketed Cetylpyridinium Chloride (CPC) mouthwash alongside a marketed Stannous Fluoride ...