Oral MalodorPhase 3NCT06300905
Clinical Study on Malodor
A Phase 3 study testing test product in people with Oral Malodor, run by Colgate Palmolive at 1 site in China.
Trial summary
This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of… 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?
- test product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 2 Jul 2023
- 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
- Must be male or female 18 to 70 years of age
- Must be in good general health
- Must be in good oral health based on self-assessment
- Must be available during the weeks of this study for all appointment time points
- Should have a minimum of 20 natural uncrowned teeth (excluding third molars)
- Should have a baseline mean oral malodor score greater than or equal to 6.0 and less than or equal to 8.0
- Must give written informed consent
- No known history of allergy to personal care/consumer products or their ingredients
Who cannot join
- Participation in any other oral clinical studies for the duration of this study
- Full or partial (upper or lower) dentures
- Pregnant or lactating (breast feeding)
- Use of tobacco products
- History of allergy to common toothpaste ingredients
- Use of phenolic flavored products, such as mint flavored candies and chewing gum, the morning of the study and during the sampling periods
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Individuals who, due to medical conditions, cannot go without eating or drinking for the post use treatment evaluation time points (6 hrs. + overnight)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation on Oral Malodor for a New Formula of Stannous Toothpaste as Compared to Colgate Cavity Protection Toothpaste Using Organoleptic Method
This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.
- Conditions
- Oral Malodor
- Being tested
- test product, Control product
- Keywords
- Organoleptic method, oral malodor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test productDrug
toothpaste containing 0.45% stannous fluoride
Control productDrug
toothpaste containing 0.76% sodium monofluorophosphate
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Brushing twice daily in the morning and evening with 2 minutes each time Receives: Drug: test product; Drug: Control product |
| Group II | Active comparator | Brushing twice daily in the morning and evening with 2 minutes each time Receives: Drug: test product; Drug: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organoleptic Oral Malodor Evaluations
The measured levels of oral malodor will be expressed in organoleptic scales (1-9)
Measured: Oral malodor evaluations at 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 posted8 Mar 2024
- Study start1 Jun 2023
- Primary completion2 Jul 2023
- Study completion2 Jul 2023
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deyu Hu, DDS,MS, Principal investigator, West China Dental Institute of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300905
- Sponsor's protocol ID
- CRO-2023-05-OMO-SNA-YPZ
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation on Oral Malodor for a New Formula of Stannous Toothpaste as Compared to Colgate Cavity Protection Toothpaste Using Organoleptic Method
- ClinicalTrials.gov ID
- NCT06300905
- Acronym / sponsor ID
- CRO-2023-05-OMO-SNA-YPZ
- Conditions
- Oral Malodor
- Keywords
- Organoleptic method, oral malodor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 8 Mar 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 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: test product, Drug: Control productBrushing twice daily in the morning and evening with 2 minutes each time |
| Group II | Active comparator | Drug: test product, Drug: Control productBrushing twice daily in the morning and evening with 2 minutes each time |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be male or female 18 to 70 years of age
- Must be in good general health
- Must be in good oral health based on self-assessment
- Must be available during the weeks of this study for all appointment time points
- Should have a minimum of 20 natural uncrowned teeth (excluding third molars)
Key exclusion criteria (8 listed)
- Participation in any other oral clinical studies for the duration of this study
- Full or partial (upper or lower) dentures
- Pregnant or lactating (breast feeding)
- Use of tobacco products
- History of allergy to common toothpaste ingredients
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 |
|---|---|---|
| test producttoothpaste containing 0.45% stannous fluoride | Drug | Group I, Group II |
| Control producttoothpaste containing 0.76% sodium monofluorophosphate | Drug | Group I, Group II |
Primary outcome
Organoleptic Oral Malodor Evaluations
Time frame: Oral malodor evaluations at baseline & 3 weeks
The measured levels of oral malodor will be expressed in organoleptic scales (1-9)
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 8 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Oral Malodor
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Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath
Halitosis
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.
Deyu Hu, DDS,MS principal investigator
West China Dental Institute of Chengdu
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 test product 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 8 inclusion and 8 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 8 Mar 2024. 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: Oral malodor evaluations at 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 8 Mar 2024.