Plaque, DentalPhase 3NCT06954779
Arginine Plaque Metabolism Pilot Clinical Study
A Phase 3 study testing Colgate Cavity Protection and TOM's Superior Sensitivity Relief Toothpaste in people with Plaque, Dental, run by Colgate Palmolive at 1 site in United States.
Trial summary
Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental
- What is being tested?
- Colgate Cavity Protection and TOM's Superior Sensitivity Relief Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2024to 20 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form.
- Male and female subjects aged 18-70 years, inclusive.
- Availability for the nine-week duration of the clinical research study.
- Good general health based on the opinion of the study investigator
- Good general health
Who cannot join
- Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
- Five or more carious lesions requiring immediate care.
- Concurrent participation in any other oral care clinical study or test panel.
- Self-reported pregnant or lactating women.
- Dental prophylaxis received in the past four weeks prior to baseline examinations
- History of tobacco use-smoking, vaping and chewing tobacco
Show all 10Show fewer
- Presence of orthodontic bands, presence of partial removable dentures
- Tumor(s) of the soft or hard tissues of the oral cavity
- Use of antibiotics or stain inducing medications any time during the two month prior to entry into the study
- Use of oral care products containing antimicrobials (Zn, Sn, CPC, triclosan, alcohol containing mouthwash, etc
Trial locations and contacts
1 site in 1 country.
About this study
Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.
- Conditions
- Plaque, Dental
- Being tested
- Colgate Cavity Protection, TOM's Superior Sensitivity Relief Toothpaste
- Keywords
- saliva
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate Cavity ProtectionDrug
1000ppm fluoride
TOM's Superior Sensitivity Relief ToothpasteDrug
fluoride free
| Study group | Role | What they receive |
|---|---|---|
| Test 1 toothpaste | Active comparator | fluoride toothpaste Receives: Drug: Colgate Cavity Protection |
| Test 2 toothpaste | Experimental | non fluoride toothpaste Receives: Drug: TOM's Superior Sensitivity Relief Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque collection
Fasting plaque will be collected before and after a sucrose rinse for lactic acid analysis and ammonia production.The plaque pH of collected samples will also be measured to provide trend data.
Measured: baseline, week 3, week 4, week 6, week 7, week 8, week 9
Secondary outcomes (1)
Saliva collection
Differences in the arginine concentration in saliva pre- and post-brushing with treatment. Differences in microbiome composition and activity
Measured: week 5 and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start24 Jul 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, DentalStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954779
- Sponsor's protocol ID
- CRO-2023-SAL-05-EG
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginine Plaque Metabolism Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT06954779
- Acronym / sponsor ID
- CRO-2023-SAL-05-EG
- Conditions
- Plaque, Dental
- Keywords
- saliva
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 2 May 2025 (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.
Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test 1 toothpaste | Active comparator | Drug: Colgate Cavity Protectionfluoride toothpaste |
| Test 2 toothpaste | Experimental | Drug: TOM's Superior Sensitivity Relief Toothpastenon fluoride toothpaste |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent Form.
- Male and female subjects aged 18-70 years, inclusive.
- Availability for the nine-week duration of the clinical research study.
- Good general health based on the opinion of the study investigator
- Good general health
Key exclusion criteria (10 listed)
- Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
- Five or more carious lesions requiring immediate care.
- Concurrent participation in any other oral care clinical study or test panel.
- Self-reported pregnant or lactating women.
- Dental prophylaxis received in the past four weeks prior to baseline examinations
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 |
|---|---|---|
| Colgate Cavity Protection1000ppm fluoride | Drug | Test 1 toothpaste |
| TOM's Superior Sensitivity Relief Toothpastefluoride free | Drug | Test 2 toothpaste |
Primary outcome
Plaque collection
Time frame: baseline, week 3, week 4, week 6, week 7, week 8, week 9
Fasting plaque will be collected before and after a sucrose rinse for lactic acid analysis and ammonia production.The plaque pH of collected samples will also be measured to provide trend data.
1 secondary outcome
Saliva collection
Time frame: week 5 and week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Colgate Cavity Protection and TOM's Superior Sensitivity Relief Toothpaste in people with Plaque, Dental, run by Colgate Palmolive 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 2 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plaque collection (time frame: baseline, week 3, week 4, week 6, week 7, week 8, week 9). 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 2 May 2025.