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.

August 8, 2026 updated by: Boka LLC
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

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 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whitening Toothpaste
Other: Toothpaste
Toothpaste with stain removing abilities
Placebo Comparator: Non-Whitening Toothpaste
Other: Toothpaste
Toothpaste with stain removing abilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whitening
Time Frame: 8 Weeks

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.
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boka LLC

Investigators

  • Principal Investigator: Jeffery L Milleman, DDS, MPA, Salus Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2025

Primary Completion (Actual)

November 6, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

October 18, 2025

First Posted (Actual)

October 21, 2025

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 8, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOBA-WHT-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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