Floss and Mouthwash for Dental and Gum Conditions

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Colgate Palmolive

Must not be taking: Antibiotics, Antimicrobials, Anti-inflammatories, Anticoagulants

Disqualifiers: Periodontitis, Orthodontic appliances, Immunocompromised, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

Who 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

Willing to conform to the study protocol and procedures

I have at least 20 natural teeth that can be examined.

I am 18 or older and in good health.

Exclusion Criteria

I haven't taken antibiotics, anti-inflammatory, or blood thinning drugs in the last 30 days.

Participation in any other clinical study within 30 days prior to enrollment into this study

I need dental treatment during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will brush their teeth twice daily and use either floss or one of the mouthwashes as per their assigned group

12 weeks

Regular visits for assessment at 1, 4, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Brushing and Rinsing C Experimental Treatment 3 Interventions

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.

Group II: Brushing and Rinsing B Experimental Treatment 3 Interventions

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.

Group III: Brushing and Rinsing A Experimental Treatment 3 Interventions

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.

Group IV: Brushing and Flossing Experimental Treatment 3 Interventions

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.

Group V: Brushing Placebo Group 2 Interventions

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).

Who Is Running the Clinical Trial?

Colgate Palmolive

Lead Sponsor

Trials

106

Recruited

19,100+

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

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35451656/

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38750375/

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 ...

3. jdh.adha.org jdh.adha.org/content/96/3/8

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0002817724005658

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.

5. insights.dentistry.tamu.edu insights.dentistry.tamu.edu/much-ado-about-flossing/

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10837857/

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, ...

7. ada.org ada.org/resources/ada-library/oral-health-topics/floss

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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06515483

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-shows

Flossing'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 – ...

10. jdh.adha.org jdh.adha.org/content/96/3/46

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.