Tooth ColorNCT07438990
Evaluation of the Whitening Effect in Subjects After Professional Tooth Cleaning Procedure
A study testing Whitening toothpaste and Regular toothpaste in people with Tooth Color, run by Lacer S.A. at 1 site in Spain.
Trial summary
The goal of this study is to learn if the toothpaste works to maintain effect of the professional tooth cleaning in adults. It will also learn about the safety of the product. The main questions it aims to answer are: Does the toothpaste help to maintain teeth colour after professional cleaning? Researchers will… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Color
- What is being tested?
- Whitening toothpaste and Regular toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2026to 12 Jun 2026
- 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
- Healthy 55 subjects
- Subjects of caucasian ethnicity
- Subjects aged between 18 and 65 years (extremes included)
- Subjects clinically showing stains on teeth (due to smoking, tea, coffee, wine or other food that typically stain teeth)
- Subjects having at least one natural teeth or central superior incisors (tooth 11 and 21) with color shade at the inclusion ≥12 and ≤30 according to R20 Bleaching shade guide
- Subjects registered with National Health Service (NHS)
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- Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
- Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel
- Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements
- Subjects who commit not to change their daily routine or lifestyle during the study
- Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
- Subjects informed about the test procedures who have signed a consent form and privacy agreement
Who cannot join
- Subjects who do not meet the inclusion criteria.
- Subjects with all affection which could interfere with the interpretation of the results of the study
- Subjects planning toothcare during the study period, using dental apparatus
- Subjects using dental prosthesis affecting the central superior incisors, with generalized tooth recession, malocclusion or overlapping teeth in the anterior region, with presence of caries, with dental abscess or untreated gum disease, with central superior incisor (tooth 11 or 21) evaluated and filled and who performed whitening treatments less than 6 months before the study begin
- Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study
- Subjects participating or planning to participate in other clinical trials
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- Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- Subjects that have intolerances or allergies to ingredients of the study product
- Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
- Subjects who are currently using products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
- Subjects admitted to a health or social facility
- Subjects planning a hospitalization during the study
- Subjects not able to be contacted in case of emergency
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects who have or have had a history of alcohol or drug addiction
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Cosmetic Product for Teeth Care in Maintaining the Whitening Effect of a Professional Dental Cleaning Performed by a Dentist - In Use Test Under Dentist Control Study
The goal of this study is to learn if the toothpaste works to maintain effect of the professional tooth cleaning in adults. It will also learn about the safety of the product. The main questions it aims to answer are:
- Does the toothpaste help to maintain teeth colour after professional cleaning?
Researchers will compare whitening toothpaste to a regular toothpaste to see if it works to maintain effects of professional teeth cleaning.
Participants will:
- Use assigned toothpaste daily for 4 weeks
- Visit the clinic on the established days during 4 weeks for check ups and evaluation
- Conditions
- Tooth Color
- Being tested
- Whitening toothpaste, Regular toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whitening toothpasteOther
Subjects will use the whitening toothpaste 3 times daily during 4 weeks
Regular toothpasteOther
Subjects will use the regular toothpaste 3 times daily during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Whitening toothpaste | Experimental | Whitening toothpaste will be used 3 times a day during 28 days after teeth cleaning procedure. Receives: Other: Whitening toothpaste |
| Regular toothpaste | Active comparator | Regular toothpaste will be used 3 times a day during 28 days after teeth cleaning procedure. Receives: Other: Regular toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in teeth colour at by R20 Bleaching guide score at 4 weeks
The score ranges from 2 (lightest shade) to 40 (darkest shade). Improvement in colour means decrease in score number.
Measured: From Baseline (after professional teeth cleaning) to end of use at 4 weeks.
Secondary outcomes (1)
Teeth brightness variation evaluated by score at 4 weeks
The brightness will be evaluated by the score from 1 to 4, where 1 means no variation and 4 means evidant improvement
Measured: From Baseline (after professional teeth cleaning) to end of use at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start3 Mar 2026
- Primary completion12 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lacer S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonia Robas, Dr, Principal investigator, Clinica Dental Rob
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438990
- Sponsor's protocol ID
- PIT0000327/25
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only summary of the results to support the publication will be shared. No complete study documents will shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Cosmetic Product for Teeth Care in Maintaining the Whitening Effect of a Professional Dental Cleaning Performed by a Dentist - In Use Test Under Dentist Control Study
- ClinicalTrials.gov ID
- NCT07438990
- Acronym / sponsor ID
- PIT0000327/25
- Conditions
- Tooth Color
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Lacer S.A.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 27 Feb 2026 (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 goal of this study is to learn if the toothpaste works to maintain effect of the professional tooth cleaning in adults. It will also learn about the safety of the product. The main questions it aims to answer are:
- Does the toothpaste help to maintain teeth colour after professional cleaning?
Researchers will compare whitening toothpaste to a regular toothpaste to see if it works to maintain effects of professional teeth cleaning.
Participants will:
- Use assigned toothpaste daily for 4 weeks
- Visit the clinic on the established days during 4 weeks for check ups and evaluation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whitening toothpaste | Experimental | Other: Whitening toothpasteWhitening toothpaste will be used 3 times a day during 28 days after teeth cleaning procedure. |
| Regular toothpaste | Active comparator | Other: Regular toothpasteRegular toothpaste will be used 3 times a day during 28 days after teeth cleaning procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy 55 subjects
- Subjects of caucasian ethnicity
- Subjects aged between 18 and 65 years (extremes included)
- Subjects clinically showing stains on teeth (due to smoking, tea, coffee, wine or other food that typically stain teeth)
- Subjects having at least one natural teeth or central superior incisors (tooth 11 and 21) with color shade at the inclusion ≥12 and ≤30 according to R20 Bleaching shade guide
Key exclusion criteria (16 listed)
- Subjects who do not meet the inclusion criteria.
- Subjects with all affection which could interfere with the interpretation of the results of the study
- Subjects planning toothcare during the study period, using dental apparatus
- Subjects using dental prosthesis affecting the central superior incisors, with generalized tooth recession, malocclusion or overlapping teeth in the anterior region, with presence of caries, with dental abscess or untreated gum disease, with central superior incisor (tooth 11 or 21) evaluated and filled and who performed whitening treatments less than 6 months before the study begin
- Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study
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 toothpasteSubjects will use the whitening toothpaste 3 times daily during 4 weeks | Other | Whitening toothpaste |
| Regular toothpasteSubjects will use the regular toothpaste 3 times daily during 4 weeks | Other | Regular toothpaste |
Primary outcome
Change in teeth colour at by R20 Bleaching guide score at 4 weeks
Time frame: From Baseline (after professional teeth cleaning) to end of use at 4 weeks.
The score ranges from 2 (lightest shade) to 40 (darkest shade). Improvement in colour means decrease in score number.
1 secondary outcome
Teeth brightness variation evaluated by score at 4 weeks
Time frame: From Baseline (after professional teeth cleaning) to end of use at 4 weeks.
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 26 Aug 2026.
- Individual participant dataSharing planned: No. Only summary of the results to support the publication will be shared. No complete study documents will shared.
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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.
Sonia Robas, Dr principal investigator
Clinica Dental Rob
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 toothpaste and Regular toothpaste in people with Tooth Color, run by Lacer S.A. at 1 site in Spain.
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 12 inclusion and 16 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 26 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 Spain. 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.
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?
Change in teeth colour at by R20 Bleaching guide score at 4 weeks (time frame: From Baseline (after professional teeth cleaning) to end of use at 4 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 26 Aug 2026.