Stain Removal EfficacyNCT07428603
Extrinsic Tooth Whitening Evaluation of a Whitening Toothpaste
A study testing Whitening Test Dentifrice (Code 826) in people with Stain Removal Efficacy, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
This randomized, examiner-blind, parallel-group clinical study evaluated the effectiveness of a whitening toothpaste compared with a control toothpaste in removing extrinsic tooth stain over six weeks of twice-daily unsupervised use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stain Removal Efficacy
- What is being tested?
- Whitening Test Dentifrice (Code 826)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2024to 20 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-65 years in good general health
- Mean MLSI score ≥1.5 on labial surfaces of at least 8 of 12 anterior teeth
- Adequate oral hygiene and willingness to comply with study requirements
- Dental prophylaxis within past 18 months but not within past 3 months
- Willing to refrain from other whitening or oral care products during the study
Who cannot join
- Significant medical conditions or oral pathology affecting assessments
- History of adverse reactions to oral hygiene products
- Orthodontic appliances or restorations interfering with stain assessment
- Moderate or advanced periodontitis
- Recent bleaching or whitening treatments
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Six-Week Clinical Evaluation of a Toothpaste in Tooth Whitening Via Extrinsic Stain Removal
This randomized, examiner-blind, parallel-group clinical study evaluated the effectiveness of a whitening toothpaste compared with a control toothpaste in removing extrinsic tooth stain over six weeks of twice-daily unsupervised use. Adult subjects were assessed at baseline and after 7, 14, 28, and 42 days of product use using the Macpherson Modification of the Lobene Stain Index. Oral soft and hard tissues and subject-reported sensory responses were also evaluated throughout the study.
Read the detailed description
This single-site, randomized, examiner-blind, two-cell parallel clinical trial enrolled adult subjects with qualifying extrinsic tooth stain. Following baseline assessments, subjects were randomized to either a test whitening dentifrice or a marketed control dentifrice. Subjects brushed twice daily for two minutes with their assigned toothpaste and toothbrush for 42 days. Extrinsic stain on the labial surfaces of the 12 anterior teeth was evaluated at baseline and at Days 7, 14, 28, and 42 using the Macpherson Modification of the Lobene Stain Index, assessing stain intensity, stain area, and total stain scores. Safety was monitored via oral soft and hard tissue examinations and subject-reported sensory assessments. Treatment comparisons were performed using ANCOVA with baseline scores as covariates.
- Conditions
- Stain Removal Efficacy
- Being tested
- Whitening Test Dentifrice (Code 826), Control dentifrice (Code 378)
- Keywords
- tooth whitening; extrinsic stain; whitening toothpaste; Macpherson Lobene Stain Index; dentifrice; stain removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whitening Test Dentifrice (Code 826)Other
Whitening toothpaste used twice daily for two minutes per brushing for six weeks.
Control dentifrice (Code 378)Other
Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | Investigational whitening toothpaste evaluated for removal of extrinsic tooth stain over 42 days of use. Receives: Other: Whitening Test Dentifrice (Code 826) |
| Sodium Fluoride Control Dentifrice | Other | Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks. Receives: Other: Control dentifrice (Code 378) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Extrinsic Tooth Stain (Total Stain Score)
Mean change in total extrinsic stain score measured on the labial surfaces of the 12 anterior teeth using the Macpherson Modification of the Lobene Stain Index, combining stain intensity and stain area scores.
Measured: Baseline to Day 42
Secondary outcomes (1)
Change in Stain Intensity and Stain Area Scores
Mean changes in stain intensity and stain area scores at each post-baseline time point.
Measured: Baseline to Days 7, 14, 28, and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start8 Aug 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stain Removal EfficacyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 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
- NCT07428603
- Sponsor's protocol ID
- ST-24-U46
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 24 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. Aggregate results are reported, but no de-identified datasets will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six-Week Clinical Evaluation of a Toothpaste in Tooth Whitening Via Extrinsic Stain Removal
- ClinicalTrials.gov ID
- NCT07428603
- Acronym / sponsor ID
- ST-24-U46
- Conditions
- Stain Removal Efficacy
- Keywords
- tooth whitening; extrinsic stain; whitening toothpaste; Macpherson Lobene Stain Index; dentifrice; stain removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 24 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, examiner-blind, parallel-group clinical study evaluated the effectiveness of a whitening toothpaste compared with a control toothpaste in removing extrinsic tooth stain over six weeks of twice-daily unsupervised use. Adult subjects were assessed at baseline and after 7, 14, 28, and 42 days of product use using the Macpherson Modification of the Lobene Stain Index. Oral soft and hard tissues and subject-reported sensory responses were also evaluated throughout the study.
Detailed description
This single-site, randomized, examiner-blind, two-cell parallel clinical trial enrolled adult subjects with qualifying extrinsic tooth stain. Following baseline assessments, subjects were randomized to either a test whitening dentifrice or a marketed control dentifrice. Subjects brushed twice daily for two minutes with their assigned toothpaste and toothbrush for 42 days. Extrinsic stain on the labial surfaces of the 12 anterior teeth was evaluated at baseline and at Days 7, 14, 28, and 42 using the Macpherson Modification of the Lobene Stain Index, assessing stain intensity, stain area, and total stain scores. Safety was monitored via oral soft and hard tissue examinations and subject-reported sensory assessments. Treatment comparisons were performed using ANCOVA with baseline scores as covariates.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Other: Whitening Test Dentifrice (Code 826)Investigational whitening toothpaste evaluated for removal of extrinsic tooth stain over 42 days of use. |
| Sodium Fluoride Control Dentifrice | Other | Other: Control dentifrice (Code 378)Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18-65 years in good general health
- Mean MLSI score ≥1.5 on labial surfaces of at least 8 of 12 anterior teeth
- Adequate oral hygiene and willingness to comply with study requirements
- Dental prophylaxis within past 18 months but not within past 3 months
- Willing to refrain from other whitening or oral care products during the study
Key exclusion criteria (6 listed)
- Significant medical conditions or oral pathology affecting assessments
- History of adverse reactions to oral hygiene products
- Orthodontic appliances or restorations interfering with stain assessment
- Moderate or advanced periodontitis
- Recent bleaching or whitening treatments
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 |
|---|---|---|
| Whitening Test Dentifrice (Code 826)Whitening toothpaste used twice daily for two minutes per brushing for six weeks. | Other | Test Toothpaste |
| Control dentifrice (Code 378)Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks. | Other | Sodium Fluoride Control Dentifrice |
Primary outcome
Change in Extrinsic Tooth Stain (Total Stain Score)
Time frame: Baseline to Day 42
Mean change in total extrinsic stain score measured on the labial surfaces of the 12 anterior teeth using the Macpherson Modification of the Lobene Stain Index, combining stain intensity and stain area scores.
1 secondary outcome
Change in Stain Intensity and Stain Area Scores
Time frame: Baseline to Days 7, 14, 28, and 42
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 24 Feb 2026.
- Individual participant dataSharing planned: No. The sponsor does not plan to share individual participant data. Aggregate results are reported, but no de-identified datasets will be made publicly available.
Related trials for Stain Removal Efficacy
Recruiting
Oil Pulling Whitening Mouthwash
Healthy Adult Participants, Tooth Stain
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 Whitening Test Dentifrice (Code 826) in people with Stain Removal Efficacy, 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 5 inclusion and 6 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 24 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 Extrinsic Tooth Stain (Total Stain Score) (time frame: Baseline to Day 42). 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 24 Feb 2026.