Tooth DiscolorationPhase 3NCT06486974
Efficacy of Manual Toothbrushes in Removing Tooth Stains
A Phase 3 study testing NaF and Na MFP in people with Tooth Discoloration, run by Colgate Palmolive at 1 site in Dominican Republic.
Trial summary
Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- NaF and Na MFP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDominican Republic
- Study dates
- 23 Sep 2024to 8 Nov 2024
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form;
- Male and female subjects, aged 18-70, inclusive;
- Good general health and good oral health based on the opinion of the study investigator;
- Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
- A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
- Available for the duration of the study;
- Clinical evidence of a tendency to form extrinsic stains on anterior teeth.
Who cannot join
- Presence of orthodontic appliances/retainers involving scorable teeth;
- Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
- Tumor(s) of the soft or hard tissues of the oral cavity;
- Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
- Five or more carious lesions requiring immediate care;
- Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
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- Concurrent participation in another clinical study;
- Self-reported pregnancy and/or lactating women;
- Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study;
- History of allergies to oral care/personal care consumer products or their ingredients;
- History of alcohol and/or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
Read the detailed description
The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.
- Conditions
- Tooth Discoloration
- Being tested
- NaF, Na MFP
- Keywords
- Lobene Tooth Stain Index
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaFDrug
Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
Na MFPDrug
Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Colgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F)
Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush Receives: Drug: NaF |
| Group 2 | Active comparator | Colgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F)
Colgate Adult Extra Clean soft-bristle toothbrush Receives: Drug: Na MFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lobene Tooth Stain Index
Each tooth will be scored separately using a 4 point area Stain Area (extent):
(0) No stain detected
- Stain covering up to one third (1/3) of the region
- Stain covering > 1/3 to 2/3 of the region
- Stain covering > 2/3 of the region
Stain Intensity:
(0) No stain
- Light Stain - yellow to light brown or gray
- Moderate stain - medium brown
- Heavy stain - dark brown to black and intensity scale ranging from: Using the Lobene Tooth Stain Index, each tooth will be scored separately using a 4 point area and intensity scale ranging from:
Measured: Baseline, and 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start23 Sep 2024
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franklin Garcia-Godoy, DDS, MS, PhD, Principal investigator, Global Research Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486974
- Sponsor's protocol ID
- CRO-2024-08-STN-DRW-DR-BGS
- Status last verified
- Nov 2024
- First submitted
- 27 Jun 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
- ClinicalTrials.gov ID
- NCT06486974
- Acronym / sponsor ID
- CRO-2024-08-STN-DRW-DR-BGS
- Conditions
- Tooth Discoloration
- Keywords
- Lobene Tooth Stain Index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 5 Jul 2024 (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.
Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
Detailed description
The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: NaFColgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F) Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush |
| Group 2 | Active comparator | Drug: Na MFPColgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F) Colgate Adult Extra Clean soft-bristle toothbrush |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form;
- Male and female subjects, aged 18-70, inclusive;
- Good general health and good oral health based on the opinion of the study investigator;
- Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
- A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
Key exclusion criteria (11 listed)
- Presence of orthodontic appliances/retainers involving scorable teeth;
- Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
- Tumor(s) of the soft or hard tissues of the oral cavity;
- Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
- Five or more carious lesions requiring immediate care;
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 |
|---|---|---|
| NaFGroup 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study | Drug | Group 1 |
| Na MFPGroup 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study | Drug | Group 2 |
Primary outcome
Lobene Tooth Stain Index
Time frame: Baseline, and 6-weeks
Each tooth will be scored separately using a 4 point area Stain Area (extent): (0) No stain detected 1. Stain covering up to one third (1/3) of the region 2. Stain covering > 1/3 to 2/3 of the region 3. Stain covering > 2/3 of the region Stain Intensity: (0) No stain 1. Light Stain - yellow to light brown or gray 2. Moderate stain - medium brown 3. Heavy stain - dark brown to black and intensity scale ranging from: Using the Lobene Tooth Stain Index, each tooth will be scored separately using a 4 point area and intensity scale ranging from:
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Franklin Garcia-Godoy, DDS, MS, PhD principal investigator
Global Research Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NaF and Na MFP in people with Tooth Discoloration, run by Colgate Palmolive at 1 site in Dominican Republic.
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 11 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 19 Mar 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 Dominican Republic. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lobene Tooth Stain Index (time frame: Baseline, and 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.