Using a special mouthrinse to treat gingivitis in adolescents at home
Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents. A Single-center, Examiner-blind, Parallel-arm, Randomized Trial
This study is testing whether a special mouthrinse can help teenagers with gingivitis improve their gum health when used along with regular brushing and flossing at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 12 Years to 14 Years |
| Sex | All |
| Sponsor | Università degli Studi di Ferrara Academic / other |
| Locations | 1 site (Ferrara) |
| Trial ID | NCT06671106 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adolescents diagnosed with plaque-induced gingivitis who are systemically healthy and eligible for oral care due to low socio-economic status.
Not a fit: Patients who are pregnant, current smokers, or have cognitive deficits that impair compliance with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve oral health and quality of life for adolescents suffering from gingivitis.
How similar studies have performed: Previous studies have shown promising results with similar mouthrinse approaches in improving oral health, suggesting potential success for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ferrara
- Operative Unit of Dentistry — Ferrara, Italy (Recruiting)
Study contacts
- Study coordinator: Leonardo Trombelli, Full Professor and Director
- Email: leonardo.trombelli@unife.it
- Phone: +390532688507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.