Teeth Color, Teeth Staining
Conditions
Brief summary
To determine whether brushing with a non-fluoride tooth whitening dentifrice containing nHAP and a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) for the overall tooth surfaces than brushing with a commercial fluoride toothpaste for a period of 2 weeks.
Detailed description
To determine whether brushing with a non-fluoride tooth whitening dentifrice containing nHAP and a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) for the overall tooth surfaces than brushing with a commercial fluoride toothpaste for a period of 2 weeks.
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 2\) Age Aged at least 18 years. 3\) Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions. 4\) General Health Good general health with no clinically significant and relevant abnormalities of medical history or dental examination in the opinion of the investigator or dental assessor. 5\) Dental Details 1. Good oral health with 16 natural teeth including 11 of the 12 anterior teeth. 2. All facial surfaces gradable with no large restorations as judged by the investigator or dental assessor.
Exclusion criteria
Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. 2\) Breast-feeding Women who are breast-feeding. 3\) Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 4\) Clinical Study/Experimental Medication 1. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. 2. Previous participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WHITENING | 2 WEEKS | To determine whether brushing with a whitening dentifrice containing a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) Area x Intensity score for the overall tooth surfaces than brushing with a commercial fluoride non-whitening dentifrice as a negative control for 2 weeks. |
| TOOTH COLOR | 2 WEEKS | TOOTH WHITENING AND ORAL OIFT 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 2 weeks of product use. |
Countries
India
Outcome results
None listed