Tooth Stain RemovalPhase 3NCT06242769
Clinical Research Study to Evaluate the Stain Removal Efficacy
A Phase 3 study testing Stannous Fluoride Toothpaste (SnF) and Colgate Fluoride Toothpaste (CDC) in people with Tooth Stain Removal, run by Colgate Palmolive at 1 site in Puerto Rico.
Trial summary
The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Stain Removal
- What is being tested?
- Stannous Fluoride Toothpaste (SnF) and Colgate Fluoride Toothpaste (CDC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 27 Jul 2020to 14 Sep 2020
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Good general health
- Male and female subjects, aged 21-70, inclusive
- Present 12 scoreable natural anterior teeth
- A minimum mean Composite Lobene Index score of 1 or greater
- Available for the duration of the study
- Clinical evidence of a tendency to form extrinsic stain on anterior teeth
Who cannot join
- Presence of orthodontic bands
- Presence of partial removable dentures
- Tumor(s) of the soft or hard tissues of the oral cavity
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
- Five or more carious lesions requiring immediate restorative treatment
- Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study
Show all 13Show fewer
- Participation in any other clinical study or test panel within the one month prior to entry into the study
- Self-reported pregnancy and/or women who are breast feeding
- Dental prophylaxis received in the past four weeks prior to baseline examinations
- History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
- On any prescription medicines that might interfere with the study outcome
- History of alcohol and/or drug abuse
- Exposed to a tooth whitening procedure during the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Research Study to Evaluate the Stain Removal Efficacy of a Toothpaste Containing Stannous Fluoride as Compared to Negative Control Toothpaste.
The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.
- Conditions
- Tooth Stain Removal
- Being tested
- Stannous Fluoride Toothpaste (SnF), Colgate Fluoride Toothpaste (CDC)
- Keywords
- Composite Lobene, extrinsic stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous Fluoride Toothpaste (SnF)Drug
test
Colgate Fluoride Toothpaste (CDC)Drug
negative control
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min Receives: Drug: Stannous Fluoride Toothpaste (SnF); Drug: Colgate Fluoride Toothpaste (CDC) |
| Group II | Placebo comparator | Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min Receives: Drug: Stannous Fluoride Toothpaste (SnF); Drug: Colgate Fluoride Toothpaste (CDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Lobene Stain Index
subjects will be evaluated for tooth stain by the dental examiner
Measured: measurement at baseline, 3 week & 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start27 Jul 2020
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Stain RemovalStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Augusto R Elias-Boneta, DMD, MSD, Principal investigator, Dental Research Associates, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242769
- Sponsor's protocol ID
- CRO-2020-04-STN-SNF-PR-BGS
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Study to Evaluate the Stain Removal Efficacy of a Toothpaste Containing Stannous Fluoride as Compared to Negative Control Toothpaste.
- ClinicalTrials.gov ID
- NCT06242769
- Acronym / sponsor ID
- CRO-2020-04-STN-SNF-PR-BGS
- Conditions
- Tooth Stain Removal
- Keywords
- Composite Lobene, extrinsic stain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 5 Feb 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.
The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Stannous Fluoride Toothpaste (SnF), Drug: Colgate Fluoride Toothpaste (CDC)Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min |
| Group II | Placebo comparator | Drug: Stannous Fluoride Toothpaste (SnF), Drug: Colgate Fluoride Toothpaste (CDC)Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form
- Good general health
- Male and female subjects, aged 21-70, inclusive
- Present 12 scoreable natural anterior teeth
- A minimum mean Composite Lobene Index score of 1 or greater
Key exclusion criteria (13 listed)
- Presence of orthodontic bands
- Presence of partial removable dentures
- Tumor(s) of the soft or hard tissues of the oral cavity
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
- Five or more carious lesions requiring immediate restorative treatment
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 |
|---|---|---|
| Stannous Fluoride Toothpaste (SnF)test | Drug | Group I, Group II |
| Colgate Fluoride Toothpaste (CDC)negative control | Drug | Group I, Group II |
Primary outcome
Composite Lobene Stain Index
Time frame: measurement at baseline, 3 week & 6 week
subjects will be evaluated for tooth stain by the dental examiner
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 5 Feb 2024.
Related trials for Tooth Stain Removal
Recruiting
Oil Pulling Whitening Mouthwash
Healthy Adult Participants, Tooth Stain
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.
Augusto R Elias-Boneta, DMD, MSD principal investigator
Dental Research Associates, Inc
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 Stannous Fluoride Toothpaste (SnF) and Colgate Fluoride Toothpaste (CDC) in people with Tooth Stain Removal, run by Colgate Palmolive at 1 site in Puerto Rico.
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 13 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 5 Feb 2024. 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 Puerto Rico. 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.
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?
Composite Lobene Stain Index (time frame: measurement at baseline, 3 week & 6 week). 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 5 Feb 2024.