NCT06671106 Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents.
| NCT ID | NCT06671106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Università degli Studi di Ferrara |
| Condition | Gingivitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-01-07 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate if the adjunctive use of an amine and zinc lactate - containing mouthrinse may give significant benefits in the home-based treatment of plaque-induced gingivitis in adolescents. The study is based on the following hypothesis: the periodontal conditions of participants affected by gingivitis will significantly benefit from the implementation of the self-performed plaque control regimen (consisting of manual toothbrush and amine and zinc lactate toothpaste) with an amine and zinc lactate - containing mouthrinse. The benefit is expected to become manifest in terms of impact on clinical periodontal parameters, ecology of the subgingival environment, patient-reported outcomes and oral-health-related quality of life. In other words, gingivitis participants implementing their self-performed oral hygiene with the investigated mouthrinse are expected to assume a closer profile (based on the outcomes listed above) to periodontally healthy subjects when compared to gingivitis participants not using the investigated mouthrinse. One hundred fifty participants (100 adolescents with gingivitis and 50 periodontally healthy adolescents) will be selected for the study. Gingivitis patients will be asked to participate in 5 observation intervals: screening visit, study baseline, and 3 follow-up visits (3 weeks, 3 months, 6 months), while periodontally healthy controls will conclude their participation in the study within the baseline visit. According to the randomization list, at baseline gingivitis patients will receive one of the following home-based oral hygiene regimen: * test intervention (Gt group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) and amine and zinc lactate - containing mouthrinse (meridol Gum Protection); * control intervention (Gc group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection); All periodontally healthy subjects will be assigned control intervention. At baseline, both gingivitis patients and periodontally healthy subjects will undergo: * assessment of clinical periodontal parameters; * subgingival plaque sampling for microbiological analysis; * assessment of patient-reported outcomes (including oral-health related quality of life) using dedicated questionnaires; Gingivitis subjects will repeat the assessments at 3-week, 3-month, and 6-month follow-up visit. The 6-month proportion of periodontally healthy participants in each gingivitis group (Gt and Gc) will be regarded as the primary outcome of the study. Changes in clinical parameters, subgingival microbial community profile, and scores related to patient-reported outcomes will be regarded as the secondary outcome measures.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06671106 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 14 Years, studying Gingivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671106 currently recruiting?
Yes, NCT06671106 is actively recruiting participants. Contact the research team at leonardo.trombelli@unife.it for enrollment information.
Where is the NCT06671106 trial being conducted?
This trial is being conducted at Ferrara, Italy.
Who is sponsoring the NCT06671106 clinical trial?
NCT06671106 is sponsored by Università degli Studi di Ferrara. The trial plans to enroll 150 participants.