ClinicalTrials.gg
CompletedNCT07761715Updated Aug 13, 2026

The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Sensitive Whitening Toothpaste, Containing 5% KNO3 (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains Over 4 Weeks of Unsupervised Use.

An interventional study of Toothpaste in Teeth Staining, sponsored by Boka LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Boka LLC · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Tooth Discoloration with a site in United States — 3 open to participants now, 3 under way, none of them phase 3. Tooth Discoloration · United States.

Enrollment
6th of 13
100 · median 91
Started
2026
with 2 others
No phase
12 of 13
3 open now
Registered
11th of 13
by date
Lead sponsor
2 of 13
Boka LLC

Among the 13 studies in Tooth Discoloration with a site in United States, this one is the 6th largest by enrollment, is one of 3 that started in 2026, is one of 12 with no phase, and was the 11th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 3 open
Phase 21 · 0 open

By the year they started

First in 2006; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 91 across the 13 interventional studies. Of the 10 that completed or were terminated, 1 (10%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Tooth Discoloration with a site in United States, or all of them as a file.
02

Study 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 4 Weeks of Unsupervised Use.

03

Conditions studied

  • Teeth Staining

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be ≥18 years old, ambulatory, and ni 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 , complete a Medical History form, understand and comply with all study directions, and be available for all 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.
  • Have had dental prophylaxis within the past 18 months, but not within the past 3 months, and agree to 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 al whitening products and procedures for the duration of the study.
  • Drink stain-forming beverages daily.

Exclusion criteria

Exclusion Criteria:

  • 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 in 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, I, 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 you nursing (breast-feeding) or pregnant.
  • 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 ot 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Whitening Toothpaste

    Other: Toothpaste

  • Placebo comparator
    Non-Whitening Toothpaste

    Other: Toothpaste

Interventions

  • OtherToothpaste

    Toothpaste with stain removing abilities

06

What researchers measure

Primary outcomes

  1. Tooth color

    The Modified Lobene Stain Index (MLSI) Area x Intensity score for the overall tooth surfaces will be used for measurement of tooth color. The Primary Endpoint is the MLSI (extrinsic stain mean scores) at the 4-week time point compared to baseline.

    Time frame: 4 weeks

Secondary outcomes

  1. ORAL SOFT TISSUE INTEGRITY

    To determine the oral soft tissue (OST) tolerance of the dentifrices. To compare the change from baseline in stain levels as represented by the MLSI scores for overall, gingival, interproximal and body areas of the facial and lingual surfaces for each dentifrice after 4 weeks of product use.

    Time frame: 4 WEEKS

07

Study locations

1 site
  • Salus Research, Inc.
    Fort Wayne, Indiana 46825, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2026 to primary completion in Jun 2026, 1 month.

Of 52 interventional studies with no phase under Tooth Discoloration, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2026
First posted
Aug 12, 2026
StartActual
May 11, 2026
Primary completionActual
Jun 30, 2026
CompletionActual
Jun 30, 2026
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07761715
Lead sponsor
Boka LLC
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
May 11, 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Aug 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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