195 Participants Needed

Stannous Fluoride Toothpaste + CPC Mouthwash 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?

The aim of this study is to assess the ability of a marketed Cetylpyridinium Chloride (CPC) mouthwash alongside a marketed Stannous Fluoride (SnF2) toothpaste in improving gingival health and reducing plaque accumulation, compared to the use of a regular fluoride toothpaste alone in participants with clinically measurable plaque-induced gingivitis.

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.

What safety data exists for Stannous Fluoride Toothpaste and CPC Mouthwash for gum disease?

The provided research primarily focuses on the efficacy of cetylpyridinium chloride (CPC) and sodium fluoride in mouthrinses for controlling dental plaque and gingivitis. While these studies demonstrate the antibacterial and antiplaque properties of CPC and fluoride, they do not specifically address safety data. However, the studies imply that these ingredients are used in clinical settings, suggesting a level of safety for oral use. For comprehensive safety data, further investigation into specific safety studies or clinical trials would be necessary.12345

Is Cetylpyridinium Chloride Mouthwash, Stannous Fluoride Toothpaste a promising treatment for gum disease?

Yes, Cetylpyridinium Chloride Mouthwash and Stannous Fluoride Toothpaste are promising treatments for gum disease. They help reduce dental plaque and gingivitis, which are key factors in gum disease. Studies show that these ingredients can effectively control plaque and improve gum health.12567

What data supports the idea that Stannous Fluoride Toothpaste + CPC Mouthwash for Gum Disease is an effective treatment?

The available research shows that mouthwashes containing cetylpyridinium chloride (CPC) and sodium fluoride can help reduce dental plaque and gingivitis. One study found that a mouthwash with CPC and sodium fluoride was more effective in controlling plaque and gingivitis than a control mouthwash with only sodium fluoride. Another study demonstrated that a CPC mouthwash significantly reduced plaque and gingivitis over six months. Additionally, a CPC rinse showed a 25% reduction in plaque compared to a placebo, which was similar to the effectiveness of a leading essential oils mouthwash. These findings suggest that Stannous Fluoride Toothpaste combined with CPC Mouthwash can be an effective treatment for gum disease.128910

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
See 1 more

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
See 11 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Toothpaste/Mouthwash (SnF2 Toothpaste followed by CPC Mouthwash)Experimental Treatment2 Interventions
Group II: Negative Control Toothpaste (Sodium Fluoride Toothpaste)Active Control1 Intervention
Group III: Reference Toothpaste (SnF2 Toothpaste)Active Control1 Intervention

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:
🇪🇺
Approved in European Union as CPC Mouthwash for:
🇨🇦
Approved in Canada as Cetylpyridinium Chloride Mouthwash for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials
40
Recruited
6,000+

Published Research Related to This Trial

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.
Antibacterial and anti-biofilm activity of mouthrinses containing cetylpyridinium chloride and sodium fluoride.Latimer, J., Munday, JL., Buzza, KM., et al.[2018]
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.
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 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.
The effects of a cetylpyridinium chloride prebrushing rinse as an adjunct to oral hygiene and gingival health.Moran, J., Addy, M.[2013]

Citations

Antibacterial and anti-biofilm activity of mouthrinses containing cetylpyridinium chloride and sodium fluoride. [2018]
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. [2013]
The effects of a cetylpyridinium chloride prebrushing rinse as an adjunct to oral hygiene and gingival health. [2013]
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. [2013]
Antibacterial and antiplaque effects of a novel, alcohol-free oral rinse with cetylpyridinium chloride. [2013]
Clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride in preventing dental plaque. [2022]
Antimicrobial properties of an orthodontic adhesive combined with cetylpyridinium chloride. [2013]
A clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride to control established dental plaque and gingivitis. [2013]
Effect of amine fluoride (AmF)/stannous fluoride (SnF2) toothpaste and mouthwashes on dental plaque accumulation, gingivitis and root-surface caries. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice. [2015]
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