Status:
ACTIVE_NOT_RECRUITING
A Clinical Study to Evaluate the Stain Reduction Efficacy of a Non-Fluoride Tooth Whitening Dentifrice Containing Nano-Hydroxyapatite (nHAP) and a High Cleaning Silica Abrasive System Compared to a Commercial Fluoride Non-Whitening Dentifrice as a Negative Control
Lead Sponsor:
Boka LLC
Conditions:
Teeth Color
Teeth Staining
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- Good oral health with 16 natural teeth including 11 of the 12 anterior teeth.
- All facial surfaces gradable with no large restorations as judged by the investigator or dental assessor.
Exclusion
- 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
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07214038
Start Date
September 1 2025
End Date
November 1 2025
Last Update
October 9 2025
Active Locations (1)
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1
Global Health Research Group
New Delhi, National Capital Territory of Delhi, India, 110048