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

NCT07755800 | Not Yet Recruiting FDA Device

• 1 other identifier: 202411492
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gum Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arginine Toothpaste Use for Two Times Per Day for 6 Months

EXPERIMENTAL

Device: Arginine Toothpaste

Fluoride Toothpaste Use for Two Times Per Day for 6 Months

ACTIVE COMPARATOR

Device: Fluoride Toothpaste

Interventions

Fluoride Toothpaste DEVICE

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.

Also known as: Colgate Cavity Protection

Fluoride Toothpaste Use for Two Times Per Day for 6 Months

Arginine Toothpaste DEVICE

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.

Also known as: Tom's of Maine

Arginine Toothpaste Use for Two Times Per Day for 6 Months

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Recent myocardial infarction
• Recent cerebrovascular accident
• Recent placement of a cardiac valvular prosthesis
• Severe liver dysfunction

Sponsors & Collaborators

• Sukirth M Ganesan, BDS, PhD: lead

Study Sites (1)

The University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Sukirth Ganesan, BDS,PhD,MPH

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sukirth Ganesan, BDS,PhD,MPH

CONTACT

(319) 467-1475; sukirth-ganesan@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)