Teeth ColorNCT07214038

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

A study testing toothpaste in people with Teeth Color and Teeth Staining, run by Boka LLC at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Teeth Color, Teeth Staining
What is being tested?: toothpaste
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteIndia
Study dates: 1 Sep 2025to 1 Nov 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

India1 site

Global Health Research Group
New Delhi, National Capital Territory of Delhi, 110048

Other trials in India

About this study

Official title: 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

Read the detailed description

Conditions: Teeth Color, Teeth Staining
Being tested: toothpaste
Medical subject headings: Tooth Discoloration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

toothpasteOther
toothpaste with stain removing abilities

Study groups in NCT07214038
Study group	Role	What they receive
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. Receives: 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. Receives: Other: toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 2 WEEKS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20251 Nov 2025

First posted9 Oct 2025
Study start1 Sep 2025
Primary completion1 Oct 2025
Study completion1 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Teeth ColorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07214038
Sponsor's protocol ID: GHRG-BOKA-STAIN-2025/01
Other IDs: GHRG-BOKA-STAIN-2025/01
Status last verified: Aug 2026
First submitted: 24 Sep 2025
Last updated: 11 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
Not yet recruiting
Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching
Discolored Teeth
RecruitingObservational study
Correlation Between Colour and Hypersensitivity of First Permanent Molars With Molar Incisor Hypomineralisation (MIH)
Molar Incisor Hypomineralisation
RecruitingObservational study
Correlation Between Colour of Defect and Enamel Breakdown in First Permanent Molars With Molar Incisor Hypomineralisation (MIH)
Molar Incisor Hypomineralisation, Enamel Breakdown

All Teeth Color trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07214038
Acronym / sponsor ID: GHRG-BOKA-STAIN-2025/01
Conditions: Teeth Color, Teeth Staining
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Boka LLCIndustry (pharma, biotech, devices)
Study start: 1 Sep 2025 (actual)
Primary completion: 1 Oct 2025 (actual)
Study completion: 1 Nov 2025 (actual)
First posted: 9 Oct 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Toothpaste	Experimental	Other: toothpasteToothpaste 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.
Paste Dentifrice	Placebo comparator	Other: toothpasteToothpaste 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
toothpastetoothpaste with stain removing abilities	Other	Paste Dentifrice, Toothpaste

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
Individual participant dataSharing planned: Undecided

Related trials for Teeth Color

Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
Not yet recruiting
Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching
Discolored Teeth
RecruitingObservational study
Correlation Between Colour and Hypersensitivity of First Permanent Molars With Molar Incisor Hypomineralisation (MIH)
Molar Incisor Hypomineralisation
RecruitingObservational study
Correlation Between Colour of Defect and Enamel Breakdown in First Permanent Molars With Molar Incisor Hypomineralisation (MIH)
Molar Incisor Hypomineralisation, Enamel Breakdown

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ASHISH KAKAR, BDS principal investigator

GHRG

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing toothpaste in people with Teeth Color and Teeth Staining, run by Boka LLC at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WHITENING (time frame: 2 WEEKS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07214038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.