[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623904":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amphion® Mouthwash Group","EXPERIMENTAL","Receives non-surgical periodontal therapy followed by irrigation and daily rinsing with Amphion® Mouthwash containing the active ingredient.",[13],"Drug: Amphion® Mouthwash",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Mouthwash Group","PLACEBO_COMPARATOR","Receives non-surgical periodontal therapy followed by irrigation and daily rinsing with a placebo mouthwash identical in appearance, odor, and taste but containing no active ingredient.",[19],"Drug: Placebo Mouthwash",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Amphion® Mouthwash","All enrolled subjects first receive non-surgical periodontal treatments (scaling, root planing, debridement). Upon completion, they immediately undergo periodontal irrigation with Amphion® Mouthwash according to their group assignment and receive standardized oral hygiene instructions. Subsequently, subjects begin the home rinsing regimen: twice daily (morning and evening), using 15 mL of Amphion® Mouthwash for 1 minute per rinse before expectorating.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Mouthwash","All enrolled subjects first receive non-surgical periodontal treatments (scaling, root planing, debridement). Upon completion, they immediately undergo periodontal irrigation with Placebo Mouthwash according to their group assignment and receive standardized oral hygiene instructions. Subsequently, subjects begin the home rinsing regimen: twice daily (morning and evening), using 15 mL of Placebo Mouthwash for 1 minute per rinse before expectorating.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Lihong Lei","CONTACT","00-86-571-86726890","kqllh@zju.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Jiaqi Bao","00-86-571-87785085","baojiaqi@zju.edu.cn",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Second Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","310000","China","CN",{"type":50,"coordinates":51},"Point",[52,53],120.16142,30.29365,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":58,"phoneExt":26,"email":59},"Human Subject Research Ethics Commitee","00-86-571-87783759","keyanlunli_zheer@163.com",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100623904","phase-4-oral-health-outcomes-with-amphion-mouthwash-as-an-adjunct-to-non-surgical-periodontal-therapy-100623904",false,"NCT07402694","Oral Health Outcomes With Amphion Mouthwash as an Adjunct to Non-Surgical Periodontal Therapy","Inclusion Criteria:\n\n1. Aged between 18 and 65 years old.\n2. At least 20 natural teeth (excluding root remnants) present in the oral cavity.\n3. Diagnosed with Stage I-IV periodontitis according to the 2018 new classification of periodontal diseases.\n4. No impairment in vision, motor function, or cognitive ability, capable of understanding and cooperating with the study.\n5. Not undergoing any orthodontic treatment and not wearing removable partial dentures during the study period.\n6. Fully informed and voluntarily signed a written informed consent form.\n\nExclusion Criteria:\n\n1. Individuals allergic to any component used in the study.\n2. Pregnant or lactating women.\n3. Those who have undergone periodontal treatments such as scaling, root planing, or used antimicrobial mouthwash within the past 3 months.\n4. Those with a history of systemic hormone or antibiotic use within the past 3 months, or who are assessed as requiring adjunctive use of such medications during periodontal treatment.\n5. Individuals with underlying systemic diseases that may affect the evaluation of periodontal status, including but not limited to: abnormal liver function, renal insufficiency, hematological diseases, neurological or psychiatric disorders, systemic bone diseases, diabetes, coronary heart disease, malignant tumors, etc.\n6. Current or former smokers (including active or passive smoking), or users of other nicotine and tobacco products (such as e-cigarettes, chewing tobacco).","ALL","18 Years","65 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","Periodontitis is a chronic inflammation caused by dental plaque that can destroy periodontal tissues. Current primary treatments include mechanical removal methods such as supragingival scaling and subgingival curettage. However, issues like microbial recolonization leading to inflammation recurrence exist, often necessitating the use of antimicrobial agents. Prolonged antibiotic use, however, can easily lead to bacterial resistance.\n\nAmphion oral rinse is a novel biomimetic material mouthwash. It inhibits plaque regrowth by forming a long-lasting physical barrier and avoids flora imbalance. Compared with traditional antibiotics, this product has shown unique advantages in the adjuvant treatment of periodontal diseases. This study aims to evaluate the efficacy of Amphion rinse combined with conventional periodontal therapy in patients with stage I-IV periodontitis, including plaque control and inflammation improvement. Additionally, it will analyze its impact on the oral microbiome and collect user experience feedback to provide a reference for its clinical application.",[79,80],"Periodontitis","Mouthwash","NOT_YET_RECRUITING","2026-02-04",{"date":84,"type":85},"2026-02-11","ACTUAL",{"date":87,"type":73},"2026-03-01",{"date":89,"type":73},"2027-12-31",{"name":5,"class":6},1]