StainingNCT06613347
Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System
A study testing whitening maintenance and whitening maintenance MW in people with Staining, run by Colgate Palmolive at 1 site in United States.
Trial summary
Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Staining
- What is being tested?
- whitening maintenance and whitening maintenance MW
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 20 Dec 2024
- 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
- permanent natural teeth (6-11) (22-27)
- composite lobene =>1
- Signed Informed Consent Form
- Male and female subjects aged 18-70 years, inclusive
- Good general health and good oral health based on the opinion of the study investigator
- All maxillary anterior teeth (teeth #6 through #11) must be present;\& mandibular anterior ( Teeth #22 through 27) must be present
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- Availability for the duration of the study
- Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker
- A minimum mean of 1.5 ≥ determined by the Interproximal Modified Lobene (IML) Stain Index
- Demonstrate a tendency to form stain in anterior teeth/ Have high staining habits ( coffee/ wine/ tea drinker)
Who cannot join
- allergies
- Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer
- Restorations on the tooth to be scored which may interfere with scoring procedures
- 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
- Concurrent participation in another clinical study
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- Self-reported pregnant and/or lactating women
- History of allergies to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients
- Have dentinal sensitivity
- Taking medication within a year which could alters natural tooth color or appearance,
- Have used Professional Whitening product within a year or had a dental prophylaxis ( professional dental cleaning) within 30 days prior to the start of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
FAR Oral and Systemic Health Consulting, Inc
Costa Mesa, California, 92627
About this study
Official title: Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System of a Colgate Regimen
Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste
- Conditions
- Staining
- Being tested
- whitening maintenance, whitening maintenance MW, negative control
- Keywords
- whitening, stains, perceptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whitening maintenanceOther
Also called whitening maintenance regimen
whitening maintenance regimen
whitening maintenance MWOther
maintenance MW
negative controlOther
negative control
| Study group | Role | What they receive |
|---|---|---|
| Whitening Regimen | Experimental | Not described Receives: Other: whitening maintenance |
| Whitening MW | Active comparator | Not described Receives: Other: whitening maintenance MW |
| Negative Control | Placebo comparator | Not described Receives: Other: negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color assessment
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Measured: Baseline
Tooth color assessment
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Measured: 4 weeks
Tooth color assessment
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Measured: 8 weeks
Interproximal Modified Lobene Stain Index
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
Measured: Baseline
Interproximal Modified Lobene Stain Index
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
Measured: 4 week
Interproximal Modified Lobene Stain Index
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start7 Oct 2024
- Primary completion15 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StainingStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613347
- Sponsor's protocol ID
- CRO-2024-07-WHT- SPMW-BGS_ MH
- Status last verified
- May 2025
- First submitted
- 20 Sep 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will report only results as aggregate
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System of a Colgate Regimen
- ClinicalTrials.gov ID
- NCT06613347
- Acronym / sponsor ID
- CRO-2024-07-WHT- SPMW-BGS_ MH
- Conditions
- Staining
- Keywords
- whitening, stains, perceptions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 25 Sep 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.
Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whitening Regimen | Experimental | Other: whitening maintenance |
| Whitening MW | Active comparator | Other: whitening maintenance MW |
| Negative Control | Placebo comparator | Other: negative control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- permanent natural teeth (6-11) (22-27)
- composite lobene =>1
- Signed Informed Consent Form
- Male and female subjects aged 18-70 years, inclusive
- Good general health and good oral health based on the opinion of the study investigator
Key exclusion criteria (11 listed)
- allergies
- Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer
- Restorations on the tooth to be scored which may interfere with scoring procedures
- 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 |
|---|---|---|
| whitening maintenanceAlso: whitening maintenance regimenwhitening maintenance regimen | Other | Whitening Regimen |
| whitening maintenance MWmaintenance MW | Other | Whitening MW |
| negative controlnegative control | Other | Negative Control |
Primary outcome
Tooth color assessment
Time frame: Baseline
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Tooth color assessment
Time frame: 4 weeks
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Tooth color assessment
Time frame: 8 weeks
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Interproximal Modified Lobene Stain Index
Time frame: Baseline
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
Interproximal Modified Lobene Stain Index
Time frame: 4 week
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
Interproximal Modified Lobene Stain Index
Time frame: 8 week
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
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 21 May 2025.
- Individual participant dataSharing planned: No. It will report only results as aggregate
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whitening maintenance and whitening maintenance MW in people with Staining, run by Colgate Palmolive at 1 site in United States.
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 10 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 21 May 2025. 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 United States. 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?
Tooth color assessment (time frame: Baseline). The study lists 6 primary outcomes in all. 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 21 May 2025.