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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Sukirth M Ganesan, BDS, PhD
Study ID
NCT07755800
Status
Enrolling By Invitation

Conditions

  • Gum Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Aug 5, 2026
Status verified
Sep 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arginine Toothpaste Use for Two Times Per Day for 6 Months
  • Active Comparator: Fluoride Toothpaste Use for Two Times Per Day for 6 Months

Primary Outcome Measure

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. [ Time Frame: Baseline, 3 months, and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Iowa College of DentistryIowa CityIowa52242-

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By research site
The University of Iowa College of Dentistry· Iowa City, IA

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