Teeth StainingNCT07219342
The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains) Over 8 Weeks of Unsupervised Use.
A study testing Toothpaste in people with Teeth Staining, run by Boka LLC at 1 site in United States.
Trial summary
The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains) Over 8 Weeks of Unsupervised Use. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth Staining
- What is being tested?
- Toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 1 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between the ages of 18 and 65, ambulatory, and in good general health as determined by the Study Examiner, based upon clinical observation and the Medical/Dental History.
- Be able to understand and sign the Informed Consent, complete a Medical History form, understand and comply with al study directions, and be available for al exam periods.
- Present with adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect) and continue to meet the inclusion criteria and not fall into the categories of exclusion during the period of the study.
- Have a mean Macpherson Modified Lobene Stain Index (MLSI) score of ≥ 1.5 on the labial surfaces of at least 8 of 12 anterior teeth.
- Have a minimum of 16 natural teeth, including the four maxillary incisors.
- Have had dental prophylaxis within the past 18 months, but not within the past 3 months, and agree ot refrain from using al oral care products (other dentifrices and toothbrushes, dental floss and mouthwashes), other than their assigned product, for the duration of the study.
- Agree to refrain from using all whitening products and procedures for the duration of the study.
- Drink tea/coffee daily.
Who cannot join
- Have a history of serious medical conditions or transmittable diseases including but not limited to active hepatitis, heart irregularities, conditions requiring pre-medication for dental procedures, rheumatic heart disease, untreated diabetes mellitus, cirrhosis, leukemia, phenylketonuria, renal disease, sarcoidosis, tuberculosis, bleeding disorder, vascular disease, AIDS, history of drug allergies or idiosyncrasies, or any other medical condition that may preclude successful participation ni the trial, at the discretion of the Study Examiner.
- Have had prior significant adverse effects following the use of oral hygiene products.
- Have the presence of orthodontic bands, retainers, fixed appliances, large restorations, or removable partial dentures, which may interfere with clinical assessments of the evaluable teeth.
- Show evidence of neglected dental health in need of prompt professional attention (i.e., gross calculus deposits or rampant caries), significant oral soft tissue pathology, systemically related gingival enlargement, generalized recession, tissue damage due to ill-fitting appliances or restorations, or extreme crowding or overlapping of teeth. Periodontitis (ADA Class I, III, or IV), e.g., more than two teeth with periodontal pockets >4 mm as evidenced by purulent exudate, tooth mobility, and other signs indicating that the integrity of the data collected might be compromised.
- Have medication therapy that is current and ongoing or within the past 4 weeks, which might interfere with the outcome of the study by affecting oral tissue condition, salivation, or stain formation (particularly chronic long-term medication therapy).
- Are nursing (breast-feeding) or pregnant.
Show all 9Show fewer
- Present at baseline with any reported sensory reactions, observed gum irritation, or any condition that would interfere with subsequent clinical assessments, or subjects with a history of allergy to oral care products, severe oral cavity sensitivity, or excessive oral irritation.
- Have participated in tooth bleaching or whitening dentifrice trials within the last three months.
- Have had professional or at-home bleaching during the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains) Over 8 Weeks of Unsupervised Use.
- Conditions
- Teeth Staining
- Being tested
- Toothpaste
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothpasteOther
Toothpaste with stain removing abilities
| Study group | Role | What they receive |
|---|---|---|
| Whitening Toothpaste | Experimental | Not described Receives: Other: Toothpaste |
| Non-Whitening Toothpaste | Placebo comparator | Not described Receives: Other: Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color
The Modified Lobene Stain Index (MLSI) Area x Intensity score for the overall tooth surfaces will be used for measurment of tooth color.
The Primary Endpoint is the MLSI (extrinsic stain mean scores) at the 8-week timepoint compared to baseline. The between treatments would also be a primary endpoint after 8 weeks of unsupervised use.
Measured: 8 weeks
Secondary outcomes (1)
Whitening
To determine the improvement in tooth shade as measured by Classic Vita Shade Guide after 8 weeks of use of the two dentifrices as compared to their respective baseline shades.
The Secondary Endpoint is the L*a*b* comparison after 8 weeks of use, both within and between treatment groups. Classic Vita Shade Guide.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start11 Sep 2025
- Primary completion6 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth StainingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boka LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery L Milleman, DDS, MPA, Principal investigator, Salus Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219342
- Sponsor's protocol ID
- KOBA-WHT-2025-01
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains) Over 8 Weeks of Unsupervised Use.
- ClinicalTrials.gov ID
- NCT07219342
- Acronym / sponsor ID
- KOBA-WHT-2025-01
- Conditions
- Teeth Staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Boka LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 21 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.
The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains) Over 8 Weeks of Unsupervised Use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whitening Toothpaste | Experimental | Other: Toothpaste |
| Non-Whitening Toothpaste | Placebo comparator | Other: Toothpaste |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be between the ages of 18 and 65, ambulatory, and in good general health as determined by the Study Examiner, based upon clinical observation and the Medical/Dental History.
- Be able to understand and sign the Informed Consent, complete a Medical History form, understand and comply with al study directions, and be available for al exam periods.
- Present with adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect) and continue to meet the inclusion criteria and not fall into the categories of exclusion during the period of the study.
- Have a mean Macpherson Modified Lobene Stain Index (MLSI) score of ≥ 1.5 on the labial surfaces of at least 8 of 12 anterior teeth.
- Have a minimum of 16 natural teeth, including the four maxillary incisors.
Key exclusion criteria (9 listed)
- Have a history of serious medical conditions or transmittable diseases including but not limited to active hepatitis, heart irregularities, conditions requiring pre-medication for dental procedures, rheumatic heart disease, untreated diabetes mellitus, cirrhosis, leukemia, phenylketonuria, renal disease, sarcoidosis, tuberculosis, bleeding disorder, vascular disease, AIDS, history of drug allergies or idiosyncrasies, or any other medical condition that may preclude successful participation ni the trial, at the discretion of the Study Examiner.
- Have had prior significant adverse effects following the use of oral hygiene products.
- Have the presence of orthodontic bands, retainers, fixed appliances, large restorations, or removable partial dentures, which may interfere with clinical assessments of the evaluable teeth.
- Show evidence of neglected dental health in need of prompt professional attention (i.e., gross calculus deposits or rampant caries), significant oral soft tissue pathology, systemically related gingival enlargement, generalized recession, tissue damage due to ill-fitting appliances or restorations, or extreme crowding or overlapping of teeth. Periodontitis (ADA Class I, III, or IV), e.g., more than two teeth with periodontal pockets >4 mm as evidenced by purulent exudate, tooth mobility, and other signs indicating that the integrity of the data collected might be compromised.
- Have medication therapy that is current and ongoing or within the past 4 weeks, which might interfere with the outcome of the study by affecting oral tissue condition, salivation, or stain formation (particularly chronic long-term medication therapy).
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 |
|---|---|---|
| ToothpasteToothpaste with stain removing abilities | Other | Non-Whitening Toothpaste, Whitening Toothpaste |
Primary outcome
Tooth color
Time frame: 8 weeks
The Modified Lobene Stain Index (MLSI) Area x Intensity score for the overall tooth surfaces will be used for measurment of tooth color. The Primary Endpoint is the MLSI (extrinsic stain mean scores) at the 8-week timepoint compared to baseline. The between treatments would also be a primary endpoint after 8 weeks of unsupervised use.
1 secondary outcome
Whitening
Time frame: 8 Weeks
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 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Teeth Staining
Not yet recruiting
Children Acceptance of AgNP Mouthwash Against Chlorhexidine 0.12% and Chlorhexidine .2% Mouthwashs
Teeth Staining, Numbness of the Tongue and Soft Tissue
Not yet recruiting
Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
Gingivitis, Healthy Adult
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
A Study to Assess the Efficacy of an Experimental Mouthwash Used With a Marketed Whitening Toothpaste on Stain Build-up
Tooth Discoloration
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
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.
Jeffery L Milleman, DDS, MPA principal investigator
Salus Research, 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 Toothpaste in people with Teeth Staining, run by Boka LLC 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 8 inclusion and 9 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 11 Aug 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. Some participants in this study may receive a placebo. 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?
Tooth color (time frame: 8 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 11 Aug 2026.