GingivitisNCT07494747
Evaluation of the Effect of the Toothpaste on Delicate Gums
A study testing Gingivitis toothpaste and Regular toothpaste in people with Gingivitis, run by Lacer S.A. at 1 site in Spain.
Trial summary
The goal of this study is to learn if a toothpaste works to alleviate gingivitis in adults. It will also learn about the safety of the product. The main question it aims to answer is: Does the toothpaste help to improve signs of gingivitis? Researchers will compare gingivitis toothpaste to a regular toothpaste to see… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Gingivitis toothpaste and Regular toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 24 Mar 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects (with no specific repartition)
- Subjects of Caucasian ethnicity
- Subjects aged between 18 and 65 years (extremes included)
- Subjects clinically showing moderate gums inflammation (gingivitis grade II, in particular all gingival scores for the mean should be between 1.75 and 2.3, according to Löe and Silness gingival scoring system), in particular:
- 40% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
- 60% of them with generalized gingivitis (>30% of evaluated sites with bleeding) Repartition to be respected in both study groups.
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- Subjects with dental plaque (total plaque score at inclusion ≥2)
- Subjects registered with the national health service
- 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 centre 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
- Smokers subjects
- Subjects planning toothcare during the study period
- Subjects using dental apparatus or using dental prosthesis, with generalized tooth recession, with presence of caries, with dental abscess or signs of periodontitis (periodontal probing depth >3mm) or active periodontitis
- Subjects using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period
- 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
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- Subjects participating or planning to participate in other clinical trials
- Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- Subjects that have food intolerances or food 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 food supplement(s) and/or 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
- Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
- 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. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
CLINICA CIURANA Centre Dental
Castelldefels, Barcelona, 08860
Ciurana, +39 0382 25504, federica.ruggeri@complifegroup.com
About this study
Official title: Benchmark Controlled Evaluation of the Effect of a Cosmetic Product in Improving Gums Condition - in Use Test Under Dentist Control
The goal of this study is to learn if a toothpaste works to alleviate gingivitis in adults. It will also learn about the safety of the product. The main question it aims to answer is:
- Does the toothpaste help to improve signs of gingivitis? Researchers will compare gingivitis toothpaste to a regular toothpaste to see if it works to improve gingivitis.
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
- Gingivitis
- Being tested
- Gingivitis toothpaste, Regular toothpaste
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingivitis toothpasteOther
Subjects will use the gingivitis toothpaste 2-3 times daily during 4 weeks
Regular toothpasteOther
Subjects will use the regular toothpaste 2-3 times daily during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gingivitis tooothpaste | Experimental | Not described Receives: Other: Gingivitis toothpaste |
| Regular toothpaste | Active comparator | Not described Receives: Other: Regular toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Gingival Index at 1 month
Measured: From baseline to end of treatment at 1 month
Secondary outcomes (1)
Change in plaque index at 1 month
Measured: From baseline to end of use at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start24 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lacer S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494747
- Sponsor's protocol ID
- EC_PIT0000334/25
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 14 May 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benchmark Controlled Evaluation of the Effect of a Cosmetic Product in Improving Gums Condition - in Use Test Under Dentist Control
- ClinicalTrials.gov ID
- NCT07494747
- Acronym / sponsor ID
- EC_PIT0000334/25
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lacer S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 Mar 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 a toothpaste works to alleviate gingivitis in adults. It will also learn about the safety of the product. The main question it aims to answer is:
- Does the toothpaste help to improve signs of gingivitis? Researchers will compare gingivitis toothpaste to a regular toothpaste to see if it works to improve gingivitis.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingivitis tooothpaste | Experimental | Other: Gingivitis toothpaste |
| Regular toothpaste | Active comparator | Other: Regular toothpaste |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy male and female subjects (with no specific repartition)
- Subjects of Caucasian ethnicity
- Subjects aged between 18 and 65 years (extremes included)
- Subjects clinically showing moderate gums inflammation (gingivitis grade II, in particular all gingival scores for the mean should be between 1.75 and 2.3, according to Löe and Silness gingival scoring system), in particular:
- Subjects with dental plaque (total plaque score at inclusion ≥2)
Key exclusion criteria (18 listed)
- Subjects who do not meet the inclusion criteria
- Smokers subjects
- Subjects planning toothcare during the study period
- Subjects using dental apparatus or using dental prosthesis, with generalized tooth recession, with presence of caries, with dental abscess or signs of periodontitis (periodontal probing depth >3mm) or active periodontitis
- Subjects using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period
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 |
|---|---|---|
| Gingivitis toothpasteSubjects will use the gingivitis toothpaste 2-3 times daily during 4 weeks | Other | Gingivitis tooothpaste |
| Regular toothpasteSubjects will use the regular toothpaste 2-3 times daily during 4 weeks | Other | Regular toothpaste |
Primary outcome
Change from Baseline in the Gingival Index at 1 month
Time frame: From baseline to end of treatment at 1 month
1 secondary outcome
Change in plaque index at 1 month
Time frame: From baseline to end of use at 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No. Only summary of the results to support the publication will be shared. No complete study documents will shared.
Related trials for Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingivitis toothpaste and Regular toothpaste in people with Gingivitis, 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 14 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 14 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica Ruggeri (+39 0382 25504, federica.ruggeri@complifegroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Gingival Index at 1 month (time frame: From baseline to end of treatment at 1 month). 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 14 May 2026.