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Stannous Fluoride Toothpaste for Gum Disease

N/A

Waitlist Available

Research Sponsored by HALEON

Eligibility Criteria Checklist

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

Must have

Participant is at least 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 3, 6 and 12

Awards & highlights

Study Summary

This trial studies the effects of a special toothpaste on gingivitis & plaque, compared to regular toothpaste, over 12 weeks of brushing.

Who is the study for?

This trial is for adults over 18 with gum disease who can follow the study's schedule and procedures. They must be in good general and mental health, meet specific oral health criteria, and have signed an informed consent document.Check my eligibility

What is being tested?

The study tests if toothpaste containing 0.454% stannous fluoride is better at treating gingivitis and reducing plaque than regular fluoride toothpaste after twice-daily use for 12 weeks.See study design

What are the potential side effects?

Potential side effects may include irritation of the gums or mouth, changes in taste perception, or tooth staining due to the active ingredients in the stannous fluoride dentifrice.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 3, 6 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 3, 6 and 12

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Number of Bleeding Sites (NBS) at Week 12

Secondary outcome measures

Change from Baseline in Bleeding Index (BI) at Weeks 3, 6 and 12 (Test Product Vs Negative Control)

Change from Baseline in Mean TPI (Interproximal) at Weeks 3, 6 and 12 (Test Product Vs Negative Control)

Change from Baseline in Mean Turesky Modification of the Quigley Hein Plaque Index (TPI) (Overall) at Weeks 3, 6 and 12 (Test Product Vs Negative Control)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test ProductExperimental Treatment1 Intervention

Participants will be instructed to brush their teeth with full ribbon of toothpaste (0.454% w/w SnF2) on head of toothbrush provided for at least one (timed) minute twice a day (morning and evening) for 12 weeks.

Group II: Negative ControlActive Control1 Intervention

Participants will be instructed to brush their teeth with full ribbon of toothpaste (0.243% w/w Sodium fluoride) on head of toothbrush provided for at least one (timed) minute twice a day (morning and evening) for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stannous fluoride toothpaste

2019

Completed Phase 3

~540

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

HALEONLead Sponsor

29 Previous Clinical Trials

4,005 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals able to participate in this clinical trial at the present time?

"Unfortunately, the information available onclinicaltrials.gov affirms that this trial is not admitting any more participants at present. The medical study was first posted on December 4th 2023 and has since been updated to reflect its completion date of November 16th 2023. However, there are 29 other trials currently open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks

2023. "A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06143670.