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

Boka LLC

Status: Active, not recruiting

Conditions: Teeth Color; Teeth Staining

Treatments: Other: toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT07214038

GHRG-BOKA-STAIN-2025/01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Toothpaste

Experimental group

Description:

Toothpaste with stain removing abilities. Toothpaste contains an abrasive system that provides increased stain removal capabilities. Product will be used by teh subject at home with a toothbrush. Instructions provided for daily use of the paste with the brush. Example brushing for two minutes per occasion.

Treatment:

Other: toothpaste

Paste Dentifrice

Placebo Comparator group

Description:

Toothpaste with No stain removing abilities. The abrasive system used in teh placebo, though having cleaning properties, will not have teh ability to remove excessive stain.

Treatment:

Other: toothpaste