Brushing Regimens for Gum Disease

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two different toothpastes in reducing dental plaque and gum disease. One toothpaste, Colgate SNaP Total 10/10, 1.5 Taurate, contains stannous fluoride, while the other, Colgate Great Regular Flavor Toothpaste, uses regular fluoride. The goal is to determine which toothpaste better improves gum health. Individuals with gum disease, at least 20 natural teeth, and noticeable plaque buildup may be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to significant advancements in dental health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on any prescription medicines that might interfere with the study outcome, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the toothpaste Colgate SNaP Total 10/10, 1.5 Taurate, which contains stannous fluoride, is generally well-received by users. One study found that users of a similar Colgate Total toothpaste experienced improved gum health, particularly with reduced gingivitis. However, some users have reported side effects such as yellow or brown stains on their teeth. These stains appear only on the surface and do not harm the teeth.

The toothpaste's ability to fight bacteria contributes to better oral health, but it is important to consult a dentist if ongoing gum issues like redness or swelling occur. While the safety information for this toothpaste is encouraging, seeking personal advice from a dental professional is always recommended.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Colgate SNaP Total 10/10 with 1.5 Taurate because it offers a new approach to treating gum disease. Unlike traditional toothpastes that primarily focus on plaque removal, this formulation includes 1.5 Taurate, which is thought to enhance antibacterial properties and strengthen gums. This new active ingredient could potentially lead to improved gum health more quickly and effectively than current options.

What evidence suggests that this trial's treatments could be effective for gum disease?

Research has shown that toothpaste with stannous fluoride, such as Colgate SNaP Total 10/10, can significantly reduce gum inflammation and plaque. One study found that this toothpaste improved gum health more than other types. In this trial, participants will use either Colgate SNaP Total 10/10 or Colgate Great Regular Flavor Toothpaste. Another study demonstrated that Colgate Total Toothpaste, which contains a similar ingredient, was more effective at reducing plaque and gum disease than some other brands. This suggests that Colgate SNaP Total 10/10 might be more effective for treating gum disease than regular fluoride toothpaste. Strong evidence supports its ability to help with dental plaque and gum disease.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who are generally healthy, have at least 20 natural teeth (not counting wisdom teeth), and already show some gum inflammation and plaque buildup. Participants must be available for a 6-month study.

Inclusion Criteria

* Signed Informed Consent Form.
* Availability for the twenty four-week(6 month) duration of the clinical research study.
I am in good health and have at least 20 natural teeth, not counting wisdom teeth.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a toothpaste containing stannous fluoride or a regular fluoride toothpaste with a standard manual toothbrush

24 weeks
Baseline, 12 weeks, 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Colgate Great Regular Flavor Toothpaste
  • Colgate SNaP Total 10/10, 1.5 Taurate

Trial Overview

The study compares two tooth brushing routines: one uses a toothpaste with stannous fluoride and the other uses regular fluoride toothpaste. Both groups use standard manual toothbrushes to see which routine better reduces dental plaque and gum disease.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Test 1 toothpasteExperimental Treatment2 Interventions
Group II: Control toothpasteActive Control2 Interventions

Find a Clinic Near You

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

Effectiveness of two different herbal toothpaste formulations in ...

The mean reduction in gingival index (GI) scores was 25.92% and 19.14% in the test and control groups respectively. There was no significant difference between ...

A 6-Month Randomized Controlled Trial to Measure the ...

The results of this clinical trial showed statistically significantly improved clinical outcomes for reduction of gingival inflammation and improvement in ...

Six Month Plaque and Gingivitis Study Using Colgate Total ...

The objective of this randomized, single center, parallel clinical research study is to evaluate the comparative efficacy performance of three dentifrices - ...

Role of Colgate Total toothpaste in helping control plaque and ...

The results showed statistically significant reductions in plaque index, gingival inflammation and bleeding on probing. The overall conclusion ...

Brushing Regimens for Gum Disease · Info for Participants

This Phase 3 medical study run by Colgate Palmolive needs participants to evaluate whether Colgate Great Regular Flavor Toothpaste and Colgate SNaP Total ...

Colgate® Total Gum Protect Whitening

Warnings · When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist. · Stop use and ask a dentist ...

Active Prevention - Compendium

Practical Implications: The highly stabilized stannous ion in SNaP toothpaste confers potent, sustained antibacterial activity that can contribute to improved ...

Colgate Total

† Based on clinical study with 40 patients using Colgate Total, 100% of patients achieved improvement in gingivitis index from baseline after using Colgate ...

Gum Disease

Colgate Total® works better than ordinary toothpaste† to help prevent and treat gingivitis. Rev 2/2012. Print 12/2012. *Illustration based on a clinical study ...

Colgate Total® Toothpaste | Whole Mouth Health

Colgate Total Active Prevention System is 15x more effective at fighting the root cause of many oral health problems such as gingivitis and cavities.