Oral MalodorPhase 3NCT07223073
A Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste
A Phase 3 study testing 0.454% stannous fluoride and 0.76% sodium monofluorophosphate in people with Oral Malodor, run by Colgate Palmolive at 1 site in Thailand.
Trial summary
To investigate the clinical efficacy of a new toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores 12 hours post-brushing overnight after 3 weeks of twice a day (morning and evening)… 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?
- 0.454% stannous fluoride and 0.76% sodium monofluorophosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 21 Dec 2017to 12 Jan 2018
- 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
- Male and female adults between the ages of 18-70 (inclusive)
- Subjects must be in general good health
- Subjects must be in good oral health based on self-assessment
- Subjects must be available for the duration of the study for all time point assessments
- Subjects were required to possess a minimum of 20 natural uncrowned teeth (excluding third molars)
- Subjects were required to sign an Informed Consent form
- No known history or allergies to personal care/consumer products or their ingredients.
Who cannot join
- Participated in any other oral clinical studies during the duration of this study
- Had full or partial (upper or lower) dentures
- Women who are pregnant or lactating (breast feeding)
- Use of tobacco products, (5) History of allergies to common mouthwash ingredients
- Use of phenolic flavored products, such as mint flavored candies and chewing gum the morning of the study of during the sampling periods
- Immune compromised individuals (HIV, AIDS, immune suppressive drug therapy
- Individuals who, due to medical conditions cannot go without eating or drinking for the post use treatment evaluation time points (6-hours plus overnight).
Trial locations and contacts
1 site in 1 country.
Thailand1 site
M U International Oral Science Research, Ltd.
Bangkok, Bangkok, 10250
About this study
Official title: A Randomized Single-center, Double-blind, Two-cell Parallel-group Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Oral Malodor 12 Hours Post-brushing Overnight After 3 Weeks of Twice a Day (Morning and Evening) Product Use.
To investigate the clinical efficacy of a new toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores 12 hours post-brushing overnight after 3 weeks of twice a day (morning and evening) product use.
- Conditions
- Oral Malodor
- Being tested
- 0.454% stannous fluoride, 0.76% sodium monofluorophosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.454% stannous fluorideDrug
fluoride toothpaste
0.76% sodium monofluorophosphateDrug
regular fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test 1 toothpaste | Experimental | Not described Receives: Drug: 0.454% stannous fluoride |
| Test 2 Toothpaste | Active comparator | Not described Receives: Drug: 0.76% sodium monofluorophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Organoleptic scores for each treatment group
For each subject at each evaluation time point, the hedonic breath-odor scores assigned by the four (4) judges were averaged to yield a single subject-wise score. Statistical analyses were performed on these average organoleptic hedonic scores.
Measured: Baseline, 12 hours post brushing and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start21 Dec 2017
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
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
- Investigators
- Terdphong Triratana, DDS, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223073
- Sponsor's protocol ID
- CRO-2017-10-OM-SNHW-THA-YPZ
- Status last verified
- Oct 2025
- First submitted
- 29 Oct 2025
- Last updated
- 31 Oct 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 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-center, Double-blind, Two-cell Parallel-group Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Oral Malodor 12 Hours Post-brushing Overnight After 3 Weeks of Twice a Day (Morning and Evening) Product Use.
- ClinicalTrials.gov ID
- NCT07223073
- Acronym / sponsor ID
- CRO-2017-10-OM-SNHW-THA-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
- 21 Dec 2017 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 31 Oct 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.
To investigate the clinical efficacy of a new toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores 12 hours post-brushing overnight after 3 weeks of twice a day (morning and evening) product use.
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 toothpaste | Experimental | Drug: 0.454% stannous fluoride |
| Test 2 Toothpaste | Active comparator | Drug: 0.76% sodium monofluorophosphate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female adults between the ages of 18-70 (inclusive)
- Subjects must be in general good health
- Subjects must be in good oral health based on self-assessment
- Subjects must be available for the duration of the study for all time point assessments
- Subjects were required to possess a minimum of 20 natural uncrowned teeth (excluding third molars)
Key exclusion criteria (7 listed)
- Participated in any other oral clinical studies during the duration of this study
- Had full or partial (upper or lower) dentures
- Women who are pregnant or lactating (breast feeding)
- Use of tobacco products, (5) History of allergies to common mouthwash ingredients
- Use of phenolic flavored products, such as mint flavored candies and chewing gum the morning of the study of during the sampling periods
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 |
|---|---|---|
| 0.454% stannous fluoridefluoride toothpaste | Drug | Test 1 toothpaste |
| 0.76% sodium monofluorophosphateregular fluoride toothpaste | Drug | Test 2 Toothpaste |
Primary outcome
Mean Organoleptic scores for each treatment group
Time frame: Baseline, 12 hours post brushing and 3 weeks
For each subject at each evaluation time point, the hedonic breath-odor scores assigned by the four (4) judges were averaged to yield a single subject-wise score. Statistical analyses were performed on these average organoleptic hedonic scores.
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 31 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Oral Malodor
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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.
Terdphong Triratana, DDS principal investigator
Mahidol University
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 0.454% stannous fluoride and 0.76% sodium monofluorophosphate in people with Oral Malodor, run by Colgate Palmolive at 1 site in Thailand.
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 7 inclusion and 7 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 31 Oct 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 Thailand. 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?
Mean Organoleptic scores for each treatment group (time frame: Baseline, 12 hours post brushing and 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 31 Oct 2025.