Gum DiseaseNCT07755800
Impact of an Arginine-containing Toothpaste on the Subgingival Microbiota in Patients in Supportive Periodontal Care
A study testing Arginine Toothpaste and Fluoride Toothpaste in people with Gum Disease, run by Sukirth M Ganesan, BDS, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Gum Disease
- What is being tested?
- Arginine Toothpaste and Fluoride Toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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:
- Recent myocardial infarction
- Recent cerebrovascular accident
- Recent placement of a cardiac valvular prosthesis
- Severe liver dysfunction
- Known or suspected current malignancy
- New antibiotic use
- Note: The Principal Investigator will review all available information about the subject and make decisions regarding both enrollment and/or continued participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Iowa College of Dentistry
Iowa City, Iowa, 52242
About this study
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
- Being tested
- Arginine Toothpaste, Fluoride Toothpaste
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine ToothpasteDevice
Also called Tom's of Maine
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 ToothpasteDevice
Also called Colgate Cavity Protection
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 group | Role | What they receive |
|---|---|---|
| Arginine Toothpaste Use for Two Times Per Day for 6 Months | Experimental | Not described Receives: Device: Arginine Toothpaste |
| Fluoride Toothpaste Use for Two Times Per Day for 6 Months | Active comparator | Not described Receives: Device: Fluoride Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start5 Aug 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gum DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sukirth M Ganesan, BDS, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sukirth M Ganesan, BDS, PhD, University of Iowa
- Investigators
- Sukirth Ganesan, BDS,PhD,MPH, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755800
- Sponsor's protocol ID
- 202411492
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Arginine-containing Toothpaste on the Subgingival Microbiota in Patients in Supportive Periodontal Care
- ClinicalTrials.gov ID
- NCT07755800
- Acronym / sponsor ID
- 202411492
- Conditions
- Gum Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Sukirth M Ganesan, BDS, PhDUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (19 listed)
- 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…).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arginine ToothpasteAlso: Tom's of MaineParticipants 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. | Device | Arginine Toothpaste Use for Two Times Per Day for 6 Months |
| Fluoride ToothpasteAlso: Colgate Cavity ProtectionParticipants 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. | Device | Fluoride Toothpaste Use for Two Times Per Day for 6 Months |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sukirth Ganesan, BDS,PhD,MPH principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine Toothpaste and Fluoride Toothpaste in people with Gum Disease, run by Sukirth M Ganesan, BDS, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.