Dental PlaqueNCT07419737
Dental Plaque Prevention Efficacy of a Stannous Fluoride Toothpaste
A study testing Stannous Fluoride Toothpaste (SnF) and Sodium Fluoride Dentifrice in people with Dental Plaque, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
This randomized, stratified, double-blind, two-cell parallel clinical study evaluated the dental plaque prevention efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste following a professional dental prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Stannous Fluoride Toothpaste (SnF) and Sodium Fluoride Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2024to 4 Dec 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health based on medical history
- Minimum of 18 natural teeth with scorable surfaces
- Baseline mean plaque score ≥2.0
- Willing to refrain from non-study oral hygiene products
- Willing to abstain from oral hygiene prior to study visits
- Able and willing to comply with study procedures
Who cannot join
- Known allergy to oral care products
- Conditions limiting normal brushing
- Significant medical conditions affecting study participation
- Pregnant or nursing females
- Severe periodontal disease
- Recent dental prophylaxis
- Recent participation in another dental study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dental Plaque Prevention Efficacy Evaluation and Comparison of a Stannous Fluoride Toothpaste
This randomized, stratified, double-blind, two-cell parallel clinical study evaluated the dental plaque prevention efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste following a professional dental prophylaxis. Adult subjects brushed twice daily for 14 days with their assigned dentifrice. Plaque was assessed using the Lobene-Soparkar modification of the Turesky Modification of the Quigley-Hein Plaque Index at baseline, Day 1, and Day 14 following periods of oral hygiene abstention.
Read the detailed description
This two-week, randomized, double-blind, parallel-group study evaluated plaque prevention following dental cleaning. Subjects meeting plaque qualification criteria underwent a complete prophylaxis and were randomized to either a stannous fluoride test dentifrice or a sodium fluoride control dentifrice. Subjects brushed twice daily for two minutes with the assigned product. Plaque accumulation was assessed at baseline, after one day of use, and after 14 days of use following overnight abstention from oral hygiene. Plaque was disclosed and scored on facial and lingual tooth surfaces using the Lobene-Soparkar modified Turesky Plaque Index. Treatment comparisons were performed using ANCOVA with baseline plaque as a covariate.
- Conditions
- Dental Plaque
- Being tested
- Stannous Fluoride Toothpaste (SnF), Sodium Fluoride Dentifrice
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous Fluoride Toothpaste (SnF)Drug
Test toothpaste (0.454% SnF)
Sodium Fluoride DentifriceDrug
Comparator toothpaste (0.243% NaF)
| 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 plaque prevention 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.
Whole-Mouth Dental Plaque Score (Turesky Modified Quigley-Hein Index)
Mean whole-mouth plaque index score assessed using the Lobene-Soparkar modification of the Turesky Modification of the Quigley-Hein Plaque Index. Treatment comparisons performed using ANCOVA with baseline plaque score as a covariate.
Measured: Day 14 (12 hours post-brushing following 14 days of twice-daily use)
Secondary outcomes (1)
Whole-Mouth Dental Plaque Score at Day 1
Mean whole-mouth plaque index score assessed one day after initial supervised brushing.
Measured: Day 1 (12 hours post-brushing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start16 Oct 2024
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 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
- NCT07419737
- Sponsor's protocol ID
- ST-24-U50
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Plaque Prevention Efficacy Evaluation and Comparison of a Stannous Fluoride Toothpaste
- ClinicalTrials.gov ID
- NCT07419737
- Acronym / sponsor ID
- ST-24-U50
- Conditions
- Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 19 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 randomized, stratified, double-blind, two-cell parallel clinical study evaluated the dental plaque prevention efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste following a professional dental prophylaxis. Adult subjects brushed twice daily for 14 days with their assigned dentifrice. Plaque was assessed using the Lobene-Soparkar modification of the Turesky Modification of the Quigley-Hein Plaque Index at baseline, Day 1, and Day 14 following periods of oral hygiene abstention.
Detailed description
This two-week, randomized, double-blind, parallel-group study evaluated plaque prevention following dental cleaning. Subjects meeting plaque qualification criteria underwent a complete prophylaxis and were randomized to either a stannous fluoride test dentifrice or a sodium fluoride control dentifrice. Subjects brushed twice daily for two minutes with the assigned product. Plaque accumulation was assessed at baseline, after one day of use, and after 14 days of use following overnight abstention from oral hygiene. Plaque was disclosed and scored on facial and lingual tooth surfaces using the Lobene-Soparkar modified Turesky Plaque Index. Treatment comparisons were performed using ANCOVA with baseline plaque as a covariate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 plaque prevention compared to sodium fluoride control. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Good general health based on medical history
- Minimum of 18 natural teeth with scorable surfaces
- Baseline mean plaque score ≥2.0
- Willing to refrain from non-study oral hygiene products
- Willing to abstain from oral hygiene prior to study visits
Key exclusion criteria (7 listed)
- Known allergy to oral care products
- Conditions limiting normal brushing
- Significant medical conditions affecting study participation
- Pregnant or nursing females
- Severe periodontal disease
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 |
|---|---|---|
| Stannous Fluoride Toothpaste (SnF)Test toothpaste (0.454% SnF) | Drug | Stannous Fluoride Toothpaste |
| Sodium Fluoride DentifriceComparator toothpaste (0.243% NaF) | Drug | Sodium Fluoride Control Dentifrice |
Primary outcome
Whole-Mouth Dental Plaque Score (Turesky Modified Quigley-Hein Index)
Time frame: Day 14 (12 hours post-brushing following 14 days of twice-daily use)
Mean whole-mouth plaque index score assessed using the Lobene-Soparkar modification of the Turesky Modification of the Quigley-Hein Plaque Index. Treatment comparisons performed using ANCOVA with baseline plaque score as a covariate.
1 secondary outcome
Whole-Mouth Dental Plaque Score at Day 1
Time frame: Day 1 (12 hours post-brushing)
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 19 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.
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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.
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 Stannous Fluoride Toothpaste (SnF) and Sodium Fluoride Dentifrice in people with Dental Plaque, 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 19 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?
Whole-Mouth Dental Plaque Score (Turesky Modified Quigley-Hein Index) (time frame: Day 14 (12 hours post-brushing following 14 days of twice-daily 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 19 Feb 2026.