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Anti-cavity Toothpaste

Investigative Arm- Using an 8% Arginine toothpaste for Dry Mouth

Phase 3

Waitlist Available

Led By Athena Papas, DMD, PhD

Research Sponsored by Tufts University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will look at how using a toothpaste with arginine for 3 months affects the mouth. The study will involve 70 male and female participants who will be randomly assigned to use either the

Who is the study for?

This trial is for men and women with dry mouth who meet specific health requirements. Participants will be using one of two toothpastes over three months to see if there's an improvement in their oral condition.Check my eligibility

What is being tested?

The study compares Colgate Cavity Protection Fluoride Toothpaste with Tom's of Maine Rapid Relief toothpaste, both containing arginine, to see which is better for dry mouth over a period of three months.See study design

What are the potential side effects?

Since the trial involves toothpaste use, potential side effects may include irritation in the mouth, allergic reactions or increased sensitivity. However, these are generally rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

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

Treatment Details

Study Objectives

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

Primary outcome measures

Salivary pH Impact

Secondary outcome measures

Measuring the change in the oral microbiome

Side effects data

From 2012 Phase 3 trial • 72 Patients • NCT01641237

Mouth Ulceration

Cough

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

NaF Dentifrice (1426 ppmF)

Placebo Dentifrice (0 ppmF)

NaF Dentifrice (250 ppmF)

NaF Dentifrice (1150 ppmF)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigative Arm- Using an 8% Arginine toothpasteExperimental Treatment1 Intervention

For the study period (12 weeks), subjects in the Investigative Arm will be instructed to brush their teeth with an 8% Arginine toothpaste.

Group II: Control Arm- a 1000 ppm F toothpasteActive Control1 Intervention

For the study period (12 weeks), subjects in the Control Arm will be instructed to brush their teeth with Control Arm- a 1000 ppm F toothpaste.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tufts UniversityLead Sponsor

266 Previous Clinical Trials

662,053 Total Patients Enrolled

Colgate PalmoliveIndustry Sponsor

89 Previous Clinical Trials

17,604 Total Patients Enrolled

Athena Papas, DMD, PhDPrincipal InvestigatorTufts University School of Dental Medicine

2 Previous Clinical Trials

474 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 there any available openings for patients to participate in this study?

"As per the information available on clinicaltrials.gov, this particular research endeavor is not actively seeking subjects for enrollment. The trial was listed on 6/1/2024 and last modified on 4/10/2024. However, it's noteworthy that there are currently 28 alternative clinical trials open for participant recruitment at present."

Answered by AI

Are individuals older than 50 years being sought for enrollment in this investigation?

"This research study is seeking volunteers who are older than 18 years of age but younger than 80 years."

Answered by AI

Is the employment of Tom's of Maine Rapid Relief toothpaste in this research study sanctioned by the FDA?

"According to our analysis at Power, the safety rating for Investigative Arm which involves the use of Tom's of Maine Rapid Relief toothpaste is graded as 3. This assessment aligns with it being a Phase 3 trial where there exists initial evidence supporting effectiveness and several iterations of data confirming its safety profile."

Answered by AI

Is it possible for me to participate in this medical study?

"Individuals aged between 18 and 80 years with xerostomia are sought to participate in this research. Approximately 70 volunteers will be enrolled in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

2024. "Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06365047.