Floss and Mouthwash for Dental and Gum Conditions
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of flossing and various mouthwashes in reducing dental plaque and gingivitis (gum inflammation). Participants will either continue normal brushing or add flossing or one of three mouthwash options to their routine. It suits individuals with noticeable gum inflammation and bleeding when brushing, who have at least 20 natural teeth that can be cleaned on both outer and inner surfaces. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.
Will I have to stop taking my current medications?
Yes, you will need to stop taking antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies at least 30 days before the study starts.
What is the safety track record for these treatments?
Research has shown that flossing is safe for the mouth. The materials in floss do not harm teeth or gums, and when used correctly, flossing causes no damage.
For Mouthwash A, studies have found that antimicrobial mouthwashes can help reduce dental plaque. These products are safe when used as intended.
Mouthwash B is also safe and easy to use, with no reported side effects or problems.
Mouthwash C is generally safe, though some studies mention minor side effects like tooth staining with certain ingredients. However, these effects are uncommon.
In conclusion, flossing and the mouthwashes in this study are safe and well-tolerated according to previous research.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this trial because it explores how different combinations of oral care routines—brushing alone, brushing with flossing, and brushing with various mouthwashes—impact dental and gum health. Unlike the standard care that typically emphasizes just brushing and flossing, this trial investigates whether certain mouthwashes might offer additional benefits. By understanding the effects of these distinct oral hygiene methods, scientists hope to discover which combinations are most effective in preventing dental and gum conditions. This could potentially lead to more personalized and effective oral care recommendations in the future.
What evidence suggests that this trial's treatments could be effective for dental and gum conditions?
This trial will compare the effectiveness of different oral hygiene practices. Studies have shown that flossing, performed by participants in the "Brushing and Flossing" arm, helps reduce gum swelling and bleeding between teeth, key signs of gum disease. Research indicates that regular flossing can significantly decrease these symptoms over time.
Participants in the "Brushing and Rinsing A" arm will use Mouthwash A, which contains natural oils and has reduced dental plaque and improved oral health by targeting harmful bacteria. Those in the "Brushing and Rinsing B" arm will use Mouthwash B, made with propolis, which has shown promise in reducing plaque and gum swelling. Participants in the "Brushing and Rinsing C" arm will use Mouthwash C, containing chlorhexidine, effective for short-term relief of mild gum disease. Each treatment has proven its ability to help manage plaque and gum disease, making them potentially effective options for improving dental health.678910Who Is on the Research Team?
Jeffery Milleman, DDS, MPA
Principal Investigator
Salus Research, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with dental plaque and gum disease who are looking to improve their oral health. Participants should be willing to use specific toothbrushes, floss, mouthwashes, and toothpaste provided by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants will brush their teeth twice daily and use either floss or one of the mouthwashes as per their assigned group
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Floss
Trial Overview
The study tests the effectiveness of using floss versus various mouthwashes (essential oil with alcohol, essential oil without alcohol, CPC+Zn without alcohol) in reducing dental plaque and gingivitis when combined with regular brushing.
How Is the Trial Designed?
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash C for 30 timed seconds.
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash B for 30 timed seconds.
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash A for 30 timed seconds.
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. Subjects will floss their teeth after their first brushing instance of the day per instructed method from the study site.
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. This arm will be the negative control arm (placebo comparator).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Colgate Palmolive
Lead Sponsor
Noel Wallace
Colgate Palmolive
Chief Executive Officer since 2019
MBA from Harvard Business School
Diana Haussling
Colgate Palmolive
Chief Marketing Officer since 2022
Bachelor's degree in Marketing
Citations
Efficacy of dental floss in the management of gingival health
Results: Interproximal gingival inflammation (GI = 2 and mean GI) was significantly reduced in both groups by day 30, reduction in inflammation ...
Effectiveness of dental floss in the management of gingival ...
Besides a reduction in gingival inflammation, no alterations in gingival status were observed among groups, subjects additionally instructed to ...
Efficacy of Flossing and Mouthrinsing Regimens on Plaque ...
Both flossing interventions statistically significantly reduced interproximal gingivitis and gingival bleeding at 12 weeks compared to the NC rinse; neither ...
The effect of self-reported flossing behavior on ...
Poor flossing behavior is associated with higher prevalence of cardiovascular events, increased risk of experiencing CVD mortality, and elevated CRP levels.
Much ado about flossing - Insights - dentistry.tamu.edu
The results: The water flosser group's whole mouth plaque reduction came in at about 74 percent, while the string flossing group trailed at ...
Efficacy of flossing and mouth rinsing regimens on plaque ...
This study demonstrated that the addition of EO non-alcohol containing mouthrinse to the manual toothbrushing and flossing regimen further reduces plaque, ...
Floss/Interdental Cleaners
The product components are safe for use in the mouth. Unsupervised use of the product by the average patient will not harm hard or soft oral ...
Evaluation of the Efficacy and Safety of a Loop Stretchable ...
This will be a single-blind, single-center, parallel, randomized controlled clinical trial to evaluate the efficacy and safety of Floss Loops stretchable ...
9.
safetyandhealthmagazine.com
safetyandhealthmagazine.com/articles/26654-flossings-benefits-go-beyond-gum-health-another-study-showsFlossing's benefits go beyond gum health, another study ...
What they found: Flossing at least once a week was linked to a 22% lower risk of ischemic stroke and a 44% lower risk of cardioembolic stroke – ...
Habits, Practices and Beliefs Regarding Floss and Mouthrinse ...
Over 90% of the respondents agreed that daily flossing and rinsing practices would result in healthier gums and protect their teeth from plaque and decay.
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