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OpenTrials
Active, Not Recruiting

NCT Number: NCT07214038

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Global Health Research Group

New Delhi, National Capital Territory of Delhi, 110048, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

  • Age Aged at least 18 years.
  • Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions.
  • 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.
  • 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 criteria

Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.

  • Breast-feeding Women who are breast-feeding.
  • Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • 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.

Treatment and study plan

toothpaste

Other

toothpaste with stain removing abilities

Primary outcomes

  1. WHITENING

    Time frame: 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.

  2. TOOTH COLOR

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boka LLC

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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