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NCT Number: NCT07551908

Evaluation of the Effect of the Mouthwash on Delicate Gums

The goal of this study is to learn if a mouthwash 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 mouthwash help to improve signs of gingivitis?

Participants will:

* Use mouthwash daily for 4 weeks * Visit the clinic on the established days during 4 weeks for check-ups and evaluation

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • 20% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
  • 80% of them with generalized gingivitis (>30% of evaluated sites with bleeding)
  • 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

Exclusion criteria

  • 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
  • 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 intolerances or allergies to ingredients of the study product Page 8 of 28 Clinical Study Protocol: EC_0000149/2026 of 13/03/2026
  • 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
  • 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).

Treatment and study plan

Mouthwash for delicate gums

Other

Mouthwash will be used 3 times a day after brushing during 4 weeks.

Primary outcomes

  1. Change from Baseline in Gingival Index Score at 4 weeks

    Time frame: From enrolment to the end of use at 4 weeks.

    The score is from 0 (normal gum) to 4 (severe inflammation, swelling, bleeding and presence of ulcers).

Study contacts

Contact information is provided by the study sponsor or research team.

Federica Robas, Dr.

CONTACT

[email protected]

+39 0382 25504

Sponsors and collaborators

Lead sponsor

Lacer S.A.

Industry

Registry information

Official study title

Evaluation of the Effect of a Cosmetic Product in Improving Gums Condition in Use Test Under Dentist Control.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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