Arginine Toothpaste for Gingivitis

SG
Overseen BySukirth Ganesan, BDS,PhD,MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to see how a toothpaste with arginine affects bacteria below the gum line compared to a regular fluoride toothpaste. It focuses on people with gum disease who are already getting ongoing dental care.

The main questions it aims to answer are:

* How does an arginine toothpaste affect the bacteria below the gumline?

* How does a fluoride toothpaste affect the bacteria below the gumline?

Participants will:

* Use fluoride toothpaste or arginine toothpaste twice daily for 6 months

* After receiving the toothpaste at the baseline visit, subjects will visit the clinic at 3 months and 6 months for additional data collection.

Who Is on the Research Team?

SG

Sukirth Ganesan, BDS,PhD,MPH

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for people with gum disease who are already receiving regular dental care. Participants should be able to brush their teeth twice daily and attend clinic visits over a 6-month period.

Inclusion Criteria

I am between 18 and 95 years old.
Systemically healthy
No orthodontic banding, no permanent retainers, no orthodontic appliances or removable prosthesis
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Exclusion Criteria

I have untreated or severe gum disease.
Currently participating in another clinical research study now or within the past month
I need antibiotics before procedures due to heart conditions.
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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 fluoride toothpaste or arginine toothpaste twice daily

6 months
Baseline visit, 3-month visit, 6-month visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares the effects of an arginine-containing toothpaste versus a standard fluoride toothpaste on bacteria below the gums. Participants are randomly assigned to use one type of toothpaste for 6 months, with check-ups at 3 and 6 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arginine Toothpaste Use for Two Times Per Day for 6 MonthsExperimental Treatment1 Intervention
Group II: Fluoride Toothpaste Use for Two Times Per Day for 6 MonthsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sukirth M Ganesan, BDS, PhD

Lead Sponsor