Oral MalodorPhase 3NCT07398378
Clinical Investigation of Oral Malodor for Max Fresh Toothpaste Containing Zinc Citrate Versus a Commercially Available Regular Fluoride Toothpaste
A Phase 3 study testing Max Fresh Toothpaste and Colgate Cavity Protection Toothpaste in people with Oral Malodor, run by Colgate Palmolive at 1 site in China.
Trial summary
The objective of this three-week clinical research study is to evaluate oral malodor for a toothpaste containing zinc citrate as compared to a commercially available regular fluoride toothpaste using the organoleptic method. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Malodor
- What is being tested?
- Max Fresh Toothpaste and Colgate Cavity Protection Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to 5 Jul 2026
- 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
- Adults aged 18-70 years, inclusive.
- Availability for the full three-week duration of the study.
- Good general health.
- Initial mean oral malodor (organoleptic) score ≥ 6.0 and ≤ 8.4.
- Signed informed consent form.
Who cannot join
- Presence of orthodontic bands.
- Tumors of the soft or hard tissues of the oral cavity.
- Advanced periodontal disease (e.g., purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- Five (5) or more carious lesions requiring immediate restorative treatment.
- Use of antibiotics within one (1) month prior to study entry.
- Participation in any other clinical study or test panel within one (1) month prior to study entry.
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- Dental prophylaxis within two (2) weeks prior to the initial examination.
- History of allergies to oral care/personal care products or their ingredients.
- Use of prescription medications that might interfere with study outcomes.
- Medical condition that prevents fasting (no food or drink) for up to four (4) hours.
- History of drug and/or alcohol abuse.
- Pregnant or lactating (self-reported).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of Oral Malodor for Max Fresh Toothpaste Containing Zinc Citrate Versus a Commercially Available Regular Fluoride Toothpaste Using the Organoleptic Method: a Three-week Study in China
The objective of this three-week clinical research study is to evaluate oral malodor for a toothpaste containing zinc citrate as compared to a commercially available regular fluoride toothpaste using the organoleptic method.
- Conditions
- Oral Malodor
- Being tested
- Max Fresh Toothpaste, Colgate Cavity Protection Toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Max Fresh ToothpasteDrug
0.5% zinc citrate
Colgate Cavity Protection ToothpasteDrug
sodium fluoride
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Experimental | Subjects will brush their teeth for two (2) minutes each time, twice daily (morning and evening), using the assigned study toothpaste according to the manufacturer's instructions for three (3) weeks. Receives: Drug: Max Fresh Toothpaste |
| Control toothpaste | Active comparator | Subjects will brush their teeth for two (2) minutes each time, twice daily (morning and evening), using the assigned study toothpaste according to the manufacturer's instructions for three (3) weeks. Receives: Drug: Colgate Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organoleptic Oral Malodor Evaluations
Baseline evaluations will be conducted in the morning. On the morning of the evaluation, subjects must refrain for at least six (6) hours from all oral hygiene (brushing, rinsing, and flossing) and from eating and drinking prior to the scheduled visit.
At baseline, the mean of the scores from the four judges will constitute each subject's baseline oral malodor score. Subjects with a baseline mean score ≥ 6.0 and ≤ 8.4 will be enrolled
Measured: baseline, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start12 Jun 2026
- Primary completion5 Jul 2026
- Study completion5 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MalodorStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT07398378
- Sponsor's protocol ID
- CRO-2026-02-OMO-MFX-YPZ
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2026
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Oral Malodor for Max Fresh Toothpaste Containing Zinc Citrate Versus a Commercially Available Regular Fluoride Toothpaste Using the Organoleptic Method: a Three-week Study in China
- ClinicalTrials.gov ID
- NCT07398378
- Acronym / sponsor ID
- CRO-2026-02-OMO-MFX-YPZ
- Conditions
- Oral Malodor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 5 Jul 2026 (actual)
- First posted
- 9 Feb 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.
The objective of this three-week clinical research study is to evaluate oral malodor for a toothpaste containing zinc citrate as compared to a commercially available regular fluoride toothpaste using the organoleptic method.
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 |
|---|---|---|
| Test 1 | Experimental | Drug: Max Fresh ToothpasteSubjects will brush their teeth for two (2) minutes each time, twice daily (morning and evening), using the assigned study toothpaste according to the manufacturer's instructions for three (3) weeks. |
| Control toothpaste | Active comparator | Drug: Colgate Cavity Protection ToothpasteSubjects will brush their teeth for two (2) minutes each time, twice daily (morning and evening), using the assigned study toothpaste according to the manufacturer's instructions for three (3) weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-70 years, inclusive.
- Availability for the full three-week duration of the study.
- Good general health.
- Initial mean oral malodor (organoleptic) score ≥ 6.0 and ≤ 8.4.
- Signed informed consent form.
Key exclusion criteria (12 listed)
- Presence of orthodontic bands.
- Tumors of the soft or hard tissues of the oral cavity.
- Advanced periodontal disease (e.g., purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- Five (5) or more carious lesions requiring immediate restorative treatment.
- Use of antibiotics within one (1) month prior to study entry.
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 |
|---|---|---|
| Max Fresh Toothpaste0.5% zinc citrate | Drug | Test 1 |
| Colgate Cavity Protection Toothpastesodium fluoride | Drug | Control toothpaste |
Primary outcome
Organoleptic Oral Malodor Evaluations
Time frame: baseline, 3 weeks
Baseline evaluations will be conducted in the morning. On the morning of the evaluation, subjects must refrain for at least six (6) hours from all oral hygiene (brushing, rinsing, and flossing) and from eating and drinking prior to the scheduled visit. At baseline, the mean of the scores from the four judges will constitute each subject's baseline oral malodor score. Subjects with a baseline mean score ≥ 6.0 and ≤ 8.4 will be enrolled
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 20 Oct 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. 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 Max Fresh Toothpaste and Colgate Cavity Protection Toothpaste in people with Oral Malodor, run by Colgate Palmolive at 1 site in China.
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 12 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 20 Oct 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 China. 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?
Organoleptic Oral Malodor Evaluations (time frame: baseline, 3 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 20 Oct 2026.