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

NCT07214038 | Active Not Recruiting DMC

• 1 other identifier: GHRG-BOKA-STAIN-2025/01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Teeth Color; Teeth Staining

Outcome Measures

Primary Outcomes (2)

• WHITENING

  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 WEEKS

• TOOTH COLOR

  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.

  2 WEEKS

Study Arms (2)

Toothpaste

EXPERIMENTAL

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.

Other: toothpaste

Paste Dentifrice

PLACEBO COMPARATOR

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.

Other: toothpaste

Interventions

toothpaste OTHER

toothpaste with stain removing abilities

Paste Dentifrice; Toothpaste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boka LLC: lead

Study Sites (1)

Global Health Research Group

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

Location

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• ASHISH KAKAR, BDS

  GHRG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 9, 2025
• Study Start: September 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-09

Locations

IN (1)