ClinicalTrials.gg
Enrolling by invitationNCT07755800Updated Sep 10, 2026

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

An interventional study of Arginine Toothpaste and Fluoride Toothpaste in Gum Disease, sponsored by Sukirth M Ganesan, BDS, PhD. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Sukirth M Ganesan, BDS, PhD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Gum Disease

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03

In context

Gingival Diseases

88 studies on the registry are indexed under Gingival Diseases; 23 are open to participants now.

This study's planned enrollment of 108 is above the median of 46 across 69 interventional studies indexed under Gingival Diseases.

Browse Gingival Diseases studies →

Lead sponsor

This is the only study on the registry with Sukirth M Ganesan, BDS, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Understands and is willing to sign an , 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

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, …) 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
    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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Arginine Toothpaste Use for Two Times Per Day for 6 Months

    Device: Arginine Toothpaste

  • Active comparator
    Fluoride Toothpaste Use for Two Times Per Day for 6 Months

    Device: Fluoride Toothpaste

Interventions

  • DeviceArginine 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.

    Also known as: Tom's of Maine

  • DeviceFluoride 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.

    Also known as: Colgate Cavity Protection

06

What researchers measure

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.

    Time frame: Baseline, 3 months, and 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.

Of 37 non-industry interventional studies with no phase under Gingival Diseases, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's planned 23 months is above that.

Counting every sponsor, half of 43 studies reached it within 15 months; a quarter within 7 and three quarters within 25.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2026
First posted
Aug 10, 2026
StartActual
Aug 5, 2026
Primary completionEst.
Jul 2028
CompletionEst.
Jul 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07755800
Lead sponsor
Sukirth M Ganesan, BDS, PhD
Responsible party
Sukirth M Ganesan, BDS, PhD (Principal Investigator, University of Iowa) — Sponsor-investigator
First posted
Aug 10, 2026
Start date
Aug 5, 2026
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Sukirth Ganesan, BDS,PhD,MPH
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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