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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Teeth Color Teeth Staining

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Toothpaste

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.

Group Type EXPERIMENTAL

toothpaste

Intervention Type OTHER

toothpaste with stain removing abilities

Paste Dentifrice

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.

Group Type PLACEBO_COMPARATOR

toothpaste

Intervention Type OTHER

toothpaste with stain removing abilities

Interventions

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toothpaste

toothpaste with stain removing abilities

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes