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Antimicrobial Agent

Stannous Fluoride Toothpaste + CPC Mouthwash for Gum Disease

N/A

Recruiting

Research Sponsored by HALEON

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant in good general and mental health with no clinically significant abnormalities

Participant is at least 18 years old

Must not have

Pregnant or breastfeeding female participants

Participant with periodontal and dental exclusions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6 and week 12

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using a specific mouthwash and toothpaste together can improve gum health and reduce plaque better than just using a regular toothpaste in people with gum disease caused by plaque."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include tooth staining, a change in taste perception, or mouth irritation from using stannous fluoride toothpaste or CPC mouthwash. These are typically mild but can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in good physical and mental health with no major health issues.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I do not have major dental or gum problems.

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I do not have severe oral health issues that could affect the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash versus [vs.] Negative Control Toothpaste)

Secondary study objectives

Interproximal Mean BI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste)

Interproximal Mean BI at Weeks 6 and 12 (Toothpaste/Mouthwash vs. Negative Control Toothpaste)

Interproximal Mean MGI at Weeks 6 and 12 (Reference Toothpaste vs. Negative Control Toothpaste)

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Toothpaste/Mouthwash (SnF2 Toothpaste followed by CPC Mouthwash)Experimental Treatment2 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 Control1 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 Control1 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.

0 / 5Eligibility criteria met