Impact of an Arginine-containing Toothpaste on the Subgingival Microbiota in Patients in Supportive Periodontal Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gum Disease
• Intervention / Treatment: Device: Arginine Toothpaste; Device: Fluoride Toothpaste

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sukirth Ganesan, BDS,PhD,MPH; Phone Number: (319) 467-1475; Email: sukirth-ganesan@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Understands and is willing to sign an Informed Consent, approved by the local Ethics Committee.
• Female or male, ages 18-95 years old (inclusive)
• Systemically healthy.
• Presence of at least three evaluable teeth in each quadrant.
• Moderate gingival inflammation, with at least a 10% of bleeding on probing (BOP) will be required together with moderate level of plaque.
• No Grade 3 Tooth Mobility
• Treated stage II or III periodontitis patients, whose active treatment has finalized more than 6 months before. Stage II - Interdental clinical attachment level (CAL) at the site of greatest loss equal to 3 to 4 millimeters with maximum probing depth of less than or equal to 5 millimeters. Stage III - Interdental CAL at the site of greatest loss greater than equal to 5 millimeters, probing depth (PD) greater than or equal to 6 millimeters, and radiographic vertical bone loss
• Enrolled in a periodontal maintenance treatment program
• No orthodontic banding (no permanent retainers, no orthodontic appliances (i.e., no removable plastic/metal retainer) or removable prosthesis (no removable partial and/or full denture).
• Subjects willing to participate and comply with the requirements of the study.
• Subjects that brush their teeth regularly (once or twice daily).
• Able to travel to and attend 4 research study visits over the span of the next 6 months.
• Able to independently provide consent for oneself.
• Fluent in reading, comprehending, and speaking English without assistance from a translator.
• If a patient is using prevident, they must be willing to stop using it.

Exclusion Criteria:

• Untreated or uncontrolled periodontitis or advanced (advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
• Antibiotics intake within the previous month.
• Pregnant women and/or breastfeeding women
• Any adverse medical history (controlled and uncontrolled diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
• Conditions which require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).
• Not willing to comply with the study protocol recommendation and visit schedule.
• Current smokers or those using tobacco or vaping products.
• Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care
• Currently participating in another clinical research study now and/or within the past month.
• Has a history of allergies to oral care or personal care consumer products or their ingredients
• Has an existing medical condition that prohibits eating or drinking for periods up to 4 hours.

• Any ongoing medical condition that makes a subject unsuitable for enrollment-or any new diagnosis that arises during the study that makes the subject unsuitable to continue-may lead to exclusion, as determined by the Principal Investigator on a case by case basis. Conditions that may result in exclusion include, but are not limited to:

  1. Recent myocardial infarction
  2. Recent cerebrovascular accident
  3. Recent placement of a cardiac valvular prosthesis
  4. Severe liver dysfunction
  5. Known or suspected current malignancy
  6. New antibiotic use
  7. Note: The Principal Investigator will review all available information about the subject and make decisions regarding both enrollment and/or continued participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arginine Toothpaste Use for Two Times Per Day for 6 Months	Device: Arginine Toothpaste; Participants will use arginine toothpaste twice daily (morning and evening) for 6 months. Sterile paper will be used to collect plaque from below the gum line at baseline, 3 months, and 6 months.; Other Names: Tom's of Maine
Active Comparator: Fluoride Toothpaste Use for Two Times Per Day for 6 Months	Device: Fluoride Toothpaste; Participants will use fluoride toothpaste twice daily (morning and evening) for 6 months. Sterile paper will be used to collect plaque from below the gum line at baseline, 3 months, and 6 months.; Other Names: Colgate Cavity Protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the abundance of microbial strains will be evaluated in all enrolled participants by collecting subgingival dental plaque, followed by genomic profiling of the samples.	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Sukirth M Ganesan, BDS, PhD
• Investigators: Principal Investigator: Sukirth Ganesan, BDS,PhD,MPH, University of Iowa

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: August 4, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases
• Other Study ID Numbers: 202411492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No