[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647709":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":44,"centralContacts":48,"locations":56,"responsibleParty":74,"collaborators":43,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":43,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":43,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":43,"overallStatus":97,"whyStopped":43,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Plovdiv Medical University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Mouthwash","EXPERIMENTAL","Participants rinsed with 15 ml of the prototype chlorhexidine-free pediatric mouthwash for 30-60 seconds twice daily for 21 days as an adjunct to standard oral hygiene.",[13],"Other: Test mouthwash",{"label":15,"type":16,"description":17,"interventionNames":18},"Chlorhexidine Mouthwash","ACTIVE_COMPARATOR","Participants rinsed with a 15 ml chlorhexidine-containing mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.",[19],"Other: Chlorhexidine-containing mouthwash",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo Mouthwash Group","PLACEBO_COMPARATOR","Participants rinsed with 15 ml of the placebo mouthwash for 30-60 seconds twice daily for 21 days as an adjunct to standard oral hygiene.",[25],"Other: Placebo mouthwash",[27,33,39],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Test mouthwash","Participants rinsed with a 15 ml prototype chlorhexidine-free pediatric mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.",[9],[32],"Sample 1",{"type":6,"name":34,"description":17,"armGroupLabels":35,"otherNames":36},"Chlorhexidine-containing mouthwash",[15],[37,38],"Eludril classic®","Positive control",{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Placebo mouthwash","Participants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.",[21],null,[45],{"name":46,"affiliation":5,"role":47},"Tanya Zalamova","PRINCIPAL_INVESTIGATOR",[49,53],{"name":46,"role":50,"phone":51,"phoneExt":43,"email":52},"CONTACT","00359878752567","tanya.zalamova@mu-plovdiv.bg",{"name":54,"role":50,"phone":43,"phoneExt":43,"email":55},"Ani Belcheva, PhD","abeltcheva@gmail.com",[57],{"facility":58,"status":43,"city":59,"state":43,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plovdiv","Plovdiv","4000","Bulgaria","BG",{"type":64,"coordinates":65},"Point",[66,67],24.75001,42.15387,{"lat":67,"lon":66},[70,72],{"name":46,"role":50,"phone":51,"phoneExt":43,"email":71},"Tanya.Zalamova@mu-plovdiv.bg",{"name":73,"role":47,"phone":43,"phoneExt":43,"email":43},"Zalamova",{"type":75,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100647709","innovative-mouthwash-in-school-aged-children-with-fixed-orthodontic-appliances-100647709",false,"NCT07710144","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","Inclusion Criteria:\n\n1. Participants aged 12 to 17 years.\n2. Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment.\n3. Generalized plaque-induced gingivitis.\n4. Full Mouth Bleeding Score greater than 30%.\n5. Gingival Index greater than 0.95 according to Loe and Silness.\n6. Written informed consent obtained from a parent or legal guardian.\n7. Participant willingness to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Refusal to participate or withdrawal of informed consent.\n2. Non-compliance with the intervention regimen or inability to attend follow-up visits.\n3. Development of an adverse reaction or condition requiring discontinuation.\n4. Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes.\n5. Presence of concomitant systemic diseases.\n6. Current systemic medication intake that could influence oral health or inflammatory status.\n7. Use of systemic or local antimicrobial agents during the previous 3 months, including mouthwashes, gels, chewing gums or other local oral agents.\n8. Known allergy or hypersensitivity to any component of the tested mouthwash formulations.\n9. Use of removable orthodontic appliances only. Inability or unwillingness to follow the study instructions.","ALL","12 Years","17 Years",{"count":87,"type":88},90,"ESTIMATED","INTERVENTIONAL",[91],"NA","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.\n\nThe 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.",[94,95,96],"Plaque-Induced Gingivitis","Dental Plaque Accumulation","Halitosis","NOT_YET_RECRUITING","2026-07-13",{"date":100,"type":101},"2026-07-17","ACTUAL",{"date":103,"type":88},"2026-09-01",{"date":105,"type":88},"2028-05-31",{"name":5,"class":6},1]