Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances

Laboratory and Clinical Evaluation of an Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances

Fixed metal orthodontic appliances create additional plaque-retentive areas around brackets, archwires and ligatures, making mechanical plaque control more difficult in children and adolescents. Increased plaque accumulation may contribute to gingival inflammation, bleeding, halitosis and early enamel changes. Therefore, adjunctive preventive agents, including mouthwashes, may be clinically useful as part of a comprehensive oral hygiene program during fixed orthodontic treatment.

The aim of the study is to evaluate the clinical effectiveness and tolerability of a test mouthwash in children and adolescents with fixed orthodontic appliances by monitoring plaque accumulation, gingival inflammation, gingival bleeding and halitosis.

Inclusion Criteria:

1. Participants aged 12 to 17 years.
2. Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment.
3. Generalized plaque-induced gingivitis.
4. Full Mouth Bleeding Score greater than 30%.
5. Gingival Index greater than 0.95 according to Loe and Silness.
6. Written informed consent obtained from a parent or legal guardian.
7. Participant willingness to comply with the study protocol.

Exclusion Criteria:

1. Refusal to participate or withdrawal of informed consent.
2. Non-compliance with the intervention regimen or inability to attend follow-up visits.
3. Development of an adverse reaction or condition requiring discontinuation.
4. Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes.
5. Presence of concomitant systemic diseases.
6. Current systemic medication intake that could influence oral health or inflammatory status.
7. Use of systemic or local antimicrobial agents during the previous 3 months, including mouthwashes, gels, chewing gums or other local oral agents.
8. Known allergy or hypersensitivity to any component of the tested mouthwash formulations.
9. Use of removable orthodontic appliances only. Inability or unwillingness to follow the study instructions.