XerostomiaPhase 3NCT06365047
Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine
A Phase 3 study testing 8% Arginine toothpaste and 1000 ppm F toothpaste in people with Xerostomia, run by Tufts University at 1 site in United States.
Trial summary
This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Xerostomia
- What is being tested?
- 8% Arginine toothpaste and 1000 ppm F toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2024to 1 Jun 2028
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers 18- 80 years of age and in general good health.
- Willing and able to understand and sign the informed consent form.
- Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months.
- Be willing to conform to the study protocol and procedures.
- Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?").
- Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min.
- No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
- Minimum of 10 teeth
Who cannot join
- Subjects unable to understand or unwilling to sign the informed consent form.
- Medical condition which requires premedication prior to dental visits/procedure.
- Active disease of the hard or soft oral tissues.
- History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Head and Neck Radiation Therapy.
- Use of antibiotics or antimicrobial drugs within 30 days prior to study start.
- Participation in any other clinical study within 1 week prior to enrollment into this study.
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- Subjects who must receive dental treatment during the study dates.
- Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- Presence of orthodontic bands.
- Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
- Use of pilocarpine or other cholinergic stimulating receptor actives prescribed after study enrollment or whose medication dose increases (stable dose for 3 months).
- People on hormone therapy
- Pregnant or lactating subjects.
- Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
- Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: Clinical Investigation to Measure the Changes in the Oral Environment Resulting From a 12 Weeks Exposure to an Arginine Containing Toothpaste
This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.
- Conditions
- Xerostomia
- Being tested
- 8% Arginine toothpaste, 1000 ppm F toothpaste
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8% Arginine toothpasteDevice
Investigative
1000 ppm F toothpasteDrug
Control
| Study group | Role | What they receive |
|---|---|---|
| Investigative Arm- Using an 8% Arginine toothpaste | Experimental | For the study period (12 weeks), subjects in the Investigative Arm will be instructed to brush their teeth with an 8% Arginine toothpaste. Receives: Device: 8% Arginine toothpaste |
| Control Arm- a 1000 ppm F toothpaste | Active comparator | For the study period (12 weeks), subjects in the Control Arm will be instructed to brush their teeth with Control Arm- a 1000 ppm F toothpaste. Receives: Drug: 1000 ppm F toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary pH Impact
The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the salivary pH of people with xerostomia.
Measured: 12 weeks
Secondary outcomes (1)
Measuring the change in the oral microbiome
The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the oral microbiome (salivary and whole mouth plaque) of people with xerostomia.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start31 Aug 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- Athena Papas, DMD, PhD, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365047
- Sponsor's protocol ID
- STUDY00004926
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Measure the Changes in the Oral Environment Resulting From a 12 Weeks Exposure to an Arginine Containing Toothpaste
- ClinicalTrials.gov ID
- NCT06365047
- Acronym / sponsor ID
- STUDY00004926
- Conditions
- Xerostomia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 15 Apr 2024 (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 is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigative Arm- Using an 8% Arginine toothpaste | Experimental | Device: 8% Arginine toothpasteFor the study period (12 weeks), subjects in the Investigative Arm will be instructed to brush their teeth with an 8% Arginine toothpaste. |
| Control Arm- a 1000 ppm F toothpaste | Active comparator | Drug: 1000 ppm F toothpasteFor the study period (12 weeks), subjects in the Control Arm will be instructed to brush their teeth with Control Arm- a 1000 ppm F toothpaste. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female volunteers 18- 80 years of age and in general good health.
- Willing and able to understand and sign the informed consent form.
- Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months.
- Be willing to conform to the study protocol and procedures.
- Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?").
Key exclusion criteria (15 listed)
- Subjects unable to understand or unwilling to sign the informed consent form.
- Medical condition which requires premedication prior to dental visits/procedure.
- Active disease of the hard or soft oral tissues.
- History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Head and Neck Radiation Therapy.
- Use of antibiotics or antimicrobial drugs within 30 days prior to study start.
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 |
|---|---|---|
| 8% Arginine toothpasteInvestigative | Device | Investigative Arm- Using an 8% Arginine toothpaste |
| 1000 ppm F toothpasteControl | Drug | Control Arm- a 1000 ppm F toothpaste |
Primary outcome
Salivary pH Impact
Time frame: 12 weeks
The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the salivary pH of people with xerostomia.
1 secondary outcome
Measuring the change in the oral microbiome
Time frame: 12 weeks
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 Feb 2026.
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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. This study is not recruiting at the moment.
Athena Papas, DMD, PhD principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 8% Arginine toothpaste and 1000 ppm F toothpaste in people with Xerostomia, run by Tufts University 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 8 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Salivary pH Impact (time frame: 12 weeks). 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 Feb 2026.