Evaluation of the Effect of the Toothpaste on Delicate Gums

May 11, 2026 updated by: Lacer S.A.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  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 washout period (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 childbearing potential).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gingivitis tooothpaste
Other: Gingivitis toothpaste
Subjects will use the gingivitis toothpaste 2-3 times daily during 4 weeks
Active Comparator: Regular toothpaste
Other: Regular toothpaste
Subjects will use the regular toothpaste 2-3 times daily during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the Gingival Index at 1 month
Time Frame: From baseline to end of treatment at 1 month
From baseline to end of treatment at 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in plaque index at 1 month
Time Frame: From baseline to end of use at 1 month
From baseline to end of use at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lacer S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC_PIT0000334/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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