Teeth Staining
Conditions
Brief 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.
Interventions
OTHERToothpaste
Toothpaste with stain removing abilities
Sponsors
Boka LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 Informed Consent, 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tooth color | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORAL SOFT TISSUE INTEGRITY | 4 WEEKS | 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. |
Countries
United States
Outcome results
None listed