Using a special mouthrinse to treat gingivitis in adolescents at home

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a mouthrinse containing amine and zinc lactate in treating plaque-induced gingivitis among adolescents. Participants will follow a home-based oral hygiene regimen that includes toothbrushing, flossing, and the use of the mouthrinse. The study aims to assess improvements in clinical periodontal parameters, the subgingival environment, and overall oral health-related quality of life. The hypothesis is that the mouthrinse will enhance the benefits of standard oral care practices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* systemically healthy;
* eligible for oral care provision by Regional Health Service due to low socio-economic status;
* at least 16 fully erupted teeth (excluding third molars);
* diagnosed with plaque-induced gingivitis (G) or periodontal health (PH) according to the World Workshop case definitions (Trombelli et al. 2018, Chapple et al. 2018);
* willing to participate in the study and capable to fully understand and comply with the study procedures (including questionnaire reading and filling).

Exclusion Criteria:

* pregnant or lactating;
* current smoking;
* motor and/or cognitive deficit impairing compliance with the study intervals or procedures;
* legal guardian not willing to either allow for subject participation in the study or ensure adherence with the study procedures;
* teeth with developmental defects (e.g., enamel pearls/projections);
* untreated oral lesions, including dental caries or endodontic lesions;
* fixed or removable orthodontic appliances or scheduled for orthodontic therapy with a timing not compatible with the experimental phase;
* use of antibiotics in the previous 3 months;
* use of medications that affect the size of the gingival tissues, such as phenytoin, sodium valproate, certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), and immune-regulating drugs (e.g., cyclosporine);
* conditions (e.g., Sjögren's syndrome, anxiety, poorly controlled diabetes) or medications (e.g., antihistamines, decongestants, antidepressants) that are associated with hyposalivation.

Where it's running

• Operative Unit of Dentistry
  Ferrara, Italy Recruiting

Study contacts

• Study coordinator: Leonardo Trombelli, Full Professor and Director
• Email: leonardo.trombelli@unife.it
• Phone: +390532688507

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.