Oral Malodor (Halitosis)NCT07425509
Evaluation of a Stannous Fluoride Dentifrice for Control of Oral Malodor
A study testing Sodium Fluoride Dentifrice and Stannous Fluoride Toothpaste (SnF) in people with Oral Malodor (Halitosis), run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
This single-center, randomized, double-blind, two-treatment crossover clinical study evaluated the safety and efficacy of a stannous fluoride-containing dentifrice compared with a sodium fluoride control dentifrice for the control of intrinsic oral malodor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Malodor (Halitosis)
- What is being tested?
- Sodium Fluoride Dentifrice and Stannous Fluoride Toothpaste (SnF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to 4 Nov 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age in good general health
- Baseline odor intensity score ≥2 after approximately 12 hours of oral hygiene abstention
- Intra-oral source of oral malodor
- At least 18 natural teeth
- Willing to comply with oral hygiene, dietary, and behavioral restrictions
- Able to provide informed consent
Who cannot join
- Allergy to oral hygiene products
- Pregnant or nursing
- Serious medical conditions affecting oral malodor
- Recent antibiotic or anti-inflammatory medication use
- Smoker or user of smokeless tobacco
- Advanced periodontal disease, frank caries, or significant oral pathology
- Participation in another oral care study within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover Clinical Evaluation of a Stannous Fluoride Containing Dentifrice on Oral Malodor
This single-center, randomized, double-blind, two-treatment crossover clinical study evaluated the safety and efficacy of a stannous fluoride-containing dentifrice compared with a sodium fluoride control dentifrice for the control of intrinsic oral malodor. Adult subjects brushed twice daily with each product during separate treatment periods following standardized wash-out periods. Oral malodor was assessed using trained organoleptic judges applying a validated Odor Intensity (OI) scale at baseline and multiple post-treatment time points.
Read the detailed description
This four-week, randomized, double-blind crossover study enrolled generally healthy adult subjects with qualifying intrinsic oral malodor. Following screening and an acclimation wash-out period using an ADA-accepted sodium fluoride dentifrice, subjects were randomized to one of two treatment sequences: TheraBreath® Healthy Gums Toothpaste or Crest® Cavity Protection Toothpaste. Each treatment period included supervised and at-home twice-daily brushing without tongue brushing or use of non-study oral hygiene products. Oral malodor was evaluated at baseline, 12-hour overnight, and 4- and 8-hour post-brushing time points on Day 1 and Day 7 using standardized organoleptic assessments performed by three trained judges. Safety was monitored through oral examinations and subject interviews. Treatment comparisons were analyzed using ANCOVA models appropriate for crossover designs.
- Conditions
- Oral Malodor (Halitosis)
- Being tested
- Sodium Fluoride Dentifrice, Stannous Fluoride Toothpaste (SnF)
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Fluoride DentifriceDrug
Comparator toothpaste (0.243% NaF)
Stannous Fluoride Toothpaste (SnF)Drug
Test toothpaste (0.454% SnF)
| Study group | Role | What they receive |
|---|---|---|
| Sodium Fluoride Control Dentifrice | Other | Dentifrice containing sodium fluoride, serving as the control comparator. Receives: Drug: Sodium Fluoride Dentifrice |
| Stannous Fluoride Toothpaste | Experimental | Dentifrice containing stannous fluoride evaluated for malodor reduction compared to sodium fluoride control. Receives: Drug: Stannous Fluoride Toothpaste (SnF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Odor Intensity Score (OI
Measured: Baseline to 12-hour overnight assessment after 7 days of product use
Secondary outcomes (1)
Change in Odor Intensity Score at Day 1
Measured: Mean change in Odor Intensity Scores from baseline to Day 1 overnight assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start9 Sep 2024
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Malodor (Halitosis)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annahita Ghassemi, PhD, Study director, Church & Dwight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425509
- Sponsor's protocol ID
- ST-24-U47
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor does not plan to share individual participant data. Summary results will be provided as required, but no de-identified datasets will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Clinical Evaluation of a Stannous Fluoride Containing Dentifrice on Oral Malodor
- ClinicalTrials.gov ID
- NCT07425509
- Acronym / sponsor ID
- ST-24-U47
- Conditions
- Oral Malodor (Halitosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 23 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.
This single-center, randomized, double-blind, two-treatment crossover clinical study evaluated the safety and efficacy of a stannous fluoride-containing dentifrice compared with a sodium fluoride control dentifrice for the control of intrinsic oral malodor. Adult subjects brushed twice daily with each product during separate treatment periods following standardized wash-out periods. Oral malodor was assessed using trained organoleptic judges applying a validated Odor Intensity (OI) scale at baseline and multiple post-treatment time points.
Detailed description
This four-week, randomized, double-blind crossover study enrolled generally healthy adult subjects with qualifying intrinsic oral malodor. Following screening and an acclimation wash-out period using an ADA-accepted sodium fluoride dentifrice, subjects were randomized to one of two treatment sequences: TheraBreath® Healthy Gums Toothpaste or Crest® Cavity Protection Toothpaste. Each treatment period included supervised and at-home twice-daily brushing without tongue brushing or use of non-study oral hygiene products. Oral malodor was evaluated at baseline, 12-hour overnight, and 4- and 8-hour post-brushing time points on Day 1 and Day 7 using standardized organoleptic assessments performed by three trained judges. Safety was monitored through oral examinations and subject interviews. Treatment comparisons were analyzed using ANCOVA models appropriate for crossover designs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Fluoride Control Dentifrice | Other | Drug: Sodium Fluoride DentifriceDentifrice containing sodium fluoride, serving as the control comparator. |
| Stannous Fluoride Toothpaste | Experimental | Drug: Stannous Fluoride Toothpaste (SnF)Dentifrice containing stannous fluoride evaluated for malodor reduction compared to sodium fluoride control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥18 years of age in good general health
- Baseline odor intensity score ≥2 after approximately 12 hours of oral hygiene abstention
- Intra-oral source of oral malodor
- At least 18 natural teeth
- Willing to comply with oral hygiene, dietary, and behavioral restrictions
Key exclusion criteria (7 listed)
- Allergy to oral hygiene products
- Pregnant or nursing
- Serious medical conditions affecting oral malodor
- Recent antibiotic or anti-inflammatory medication use
- Smoker or user of smokeless tobacco
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 |
|---|---|---|
| Sodium Fluoride DentifriceComparator toothpaste (0.243% NaF) | Drug | Sodium Fluoride Control Dentifrice |
| Stannous Fluoride Toothpaste (SnF)Test toothpaste (0.454% SnF) | Drug | Stannous Fluoride Toothpaste |
Primary outcome
Change in Odor Intensity Score (OI
Time frame: Baseline to 12-hour overnight assessment after 7 days of product use
1 secondary outcome
Change in Odor Intensity Score at Day 1
Time frame: Mean change in Odor Intensity Scores from baseline to Day 1 overnight assessment.
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 23 Feb 2026.
- Individual participant dataSharing planned: No. The sponsor does not plan to share individual participant data. Summary results will be provided as required, but no de-identified datasets will be made publicly available.
Related trials for Oral Malodor (Halitosis)
Not yet recruiting
Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
Oral Malodor (Halitosis), Oral Dryness
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.
Annahita Ghassemi, PhD study director
Church & Dwight, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Fluoride Dentifrice and Stannous Fluoride Toothpaste (SnF) in people with Oral Malodor (Halitosis), run by Church & Dwight Company, Inc. 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 6 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 23 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.
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?
Change in Odor Intensity Score (OI (time frame: Baseline to 12-hour overnight assessment after 7 days of product use). 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 23 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.