ClinicalTrials.gg
RecruitingNCT07494747Updated May 14, 2026

Evaluation of the Effect of the Toothpaste on Delicate Gums

An interventional study of Gingivitis toothpaste and Regular toothpaste in Gingivitis, sponsored by Lacer S.A.. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Lacer S.A. (part of Italfarmaco) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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
02

Conditions studied

  • Gingivitis

Browse trials for

03

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's planned enrollment of 60 is close to the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Lacer S.A. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male and female subjects (with no specific repartition)
  2. Subjects of Caucasian ethnicity
  3. Subjects aged between 18 and 65 years (extremes included)
  4. 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:

    1. 40% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
    2. 60% of them with generalized gingivitis (>30% of evaluated sites with bleeding) Repartition to be respected in both study groups.
  5. Subjects with dental plaque (total plaque score at inclusion ≥2)
  6. Subjects registered with the national health service
  7. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
  8. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
  9. 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
  10. Subjects who commit not to change their daily routine or lifestyle during the study
  11. 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
  12. Subjects informed about the test procedures who have signed a consent form and privacy agreement

Exclusion criteria

Exclusion Criteria:

  1. Subjects who do not meet the inclusion criteria
  2. Smokers subjects
  3. Subjects planning toothcare during the study period
  4. 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
  5. Subjects using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period
  6. 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
  7. Subjects participating or planning to participate in other clinical trials
  8. Subjects who participated in a similar study without respecting an adequate (at least one month)
  9. Subjects that have food intolerances or food allergies to ingredients of the study product
  10. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
  11. 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)
  12. Subjects admitted to a health or social facility
  13. Subjects planning a hospitalization during the study
  14. Subjects not able to be contacted in case of emergency
  15. Subjects deprived of freedom by administrative or legal decision or under guardianship
  16. Subjects who have or have had a history of alcohol or drug addiction
  17. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
  18. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of ).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Gingivitis tooothpaste

    Other: Gingivitis toothpaste

  • Active comparator
    Regular toothpaste

    Other: Regular toothpaste

Interventions

  • OtherGingivitis toothpaste

    Subjects will use the gingivitis toothpaste 2-3 times daily during 4 weeks

  • OtherRegular toothpaste

    Subjects will use the regular toothpaste 2-3 times daily during 4 weeks

06

What researchers measure

Primary outcomes

  1. Change from Baseline in the Gingival Index at 1 month

    Time frame: From baseline to end of treatment at 1 month

Secondary outcomes

  1. Change in plaque index at 1 month

    Time frame: From baseline to end of use at 1 month

07

Study locations

1 of 1 sites recruiting
  • CLINICA CIURANA Centre Dental
    Castelldefels, Barcelona 08860, Spain
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Only summary of the results to support the publication will be shared. No complete study documents will shared.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Sep 2026, 6 months after the start.

Of 53 industry-sponsored interventional studies with no phase under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 5. This study's planned 6 months is above that.

Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2026
First posted
Mar 27, 2026
StartActual
Mar 24, 2026
Primary completionEst.
Sep 2026
CompletionEst.
Sep 2026
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07494747
Lead sponsor
Lacer S.A.
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Mar 24, 2026
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
May 14, 2026

Study contacts

Federica Ruggeri
Contact
federica.ruggeri@complifegroup.com
+39 0382 25504

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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