Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorPlovdiv Medical University
About this trial
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.
Eligibility criteria
Qualifiers
Participants aged 12 to 17 years.
Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment.
Generalized plaque-induced gingivitis.
Full Mouth Bleeding Score greater than 30%.
Disqualifiers
Refusal to participate or withdrawal of informed consent.
Non-compliance with the intervention regimen or inability to attend follow-up visits.
Development of an adverse reaction or condition requiring discontinuation.
Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes.
Trial design
Treatments tested in this trial
- Test mouthwash
- Chlorhexidine-containing mouthwash
- Placebo mouthwash
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov