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

136 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Experimental Mouthwash for gum disease?

Research shows that mouthwashes containing antiseptic agents like chlorhexidine can significantly reduce dental plaque and gum inflammation, which are key factors in gum disease. This suggests that the Experimental Mouthwash might also be effective if it contains similar active ingredients. ^{1 2 3 4 5}

Is the mouthwash safe for humans?

Several studies have looked at the safety of different mouthwashes. One study evaluated the safety of a mouthwash with diclofenac after oral surgery, while another assessed adverse events in mouthwashes with chlorhexidine and hyaluronic acid. These studies suggest that mouthwashes can be safe, but it's important to consider specific ingredients and individual reactions. ^{6 7 8 9 10}

How does the mouthwash treatment for gum disease differ from other treatments?

This mouthwash treatment for gum disease is unique because it contains hexetidine, which is specifically assessed for its antiplaque and antigingivitis effectiveness. Unlike chlorhexidine, which is not recommended for long-term use, hexetidine offers a potentially effective alternative for managing gum disease. ^{3 11 12 13 14}

What is the purpose of this trial?

The aim of this 12-week clinical study is to evaluate the ability of an experimental mouthwash, containing 0.085 percent (%) Cetylpyridinium chloride (CPC) as an adjunct to toothbrushing with a regular fluoride toothpaste, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste alone in participants with plaque-induced mild to moderate gingivitis.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Preoperative Mouthwash in Subjects with Different Periodontal Status: A Randomised Controlled Clinical Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of mouthrinses on parameters characterizing human periodontal disease. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Triphala, Aloe vera, and Chlorhexidine Mouthwash on Gingivitis: A Randomized Controlled Clinical Trial. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

An 8-week, randomized, controlled, clinical study of the use of a 0.1% chlorhexidine mouthwash by chronic periodontitis patients. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Herbal Mouthwashes on Plaque and Inflammation Control for Patients with Gingivitis: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Influence of alcohol in mouthwashes containing triclosan and zinc: an experimental gingivitis study. [2013]

7. Italy pubmed.ncbi.nlm.nih.gov

[Double blind placebo-controlled study on efficacy, acceptability and safety of mouthwash diclofenac in oral or periodontal postoperative period]. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Reporting adverse events in randomized controlled trials in periodontology: a systematic review. [2018]

9. England pubmed.ncbi.nlm.nih.gov

The efficacy of 0.12% chlorhexidine versus 0.12% chlorhexidine plus hyaluronic acid mouthwash on healing of submerged single implant insertion areas: a short-term randomized controlled clinical trial. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Long-term efficacy of a 0.07% cetylpyridinium chloride mouth rinse in relation to plaque and gingivitis: a 6-month randomized, vehicle-controlled clinical trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Antiplaque and antigingivitis effectiveness of a hexetidine mouthwash. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of 3 Commercial Mouthwash Formulations on Clinical Parameters of Chronic Gingivitis. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Mouthrinses in "experimental gingivitis" studies. [2019]

14. Pakistan pubmed.ncbi.nlm.nih.gov

The antibacterial effect of four mouthwashes against streptococcus mutans and escherichia coli. [2022]