[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646222":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":28,"centralContacts":29,"locations":38,"responsibleParty":60,"collaborators":28,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":28,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":28,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":41,"whyStopped":28,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Bern","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Group","PLACEBO_COMPARATOR","Group P rinses twice daily with 10 ml of a placebo (pure water with flavored additive) solution",[13],"Other: Experimental gingivitis model",{"label":15,"type":16,"description":17,"interventionNames":18},"Group T1","EXPERIMENTAL","Group T1 rinses twice daily with 10 ml of 0.12% chlorhexidine solution with ADS (Anti-Discoloration System) solution (Curasept ADS 212)",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Group T2","Group T2 rinses twice daily with 10 ml of 0.12% chlorhexidine with HA (Hyaluronic Acid)",[13],[24],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Experimental gingivitis model","Participants will abolish all measures for mechanical plaque control for a period of 3 weeks according to the experimental gingivitis model.",[15,20,9],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Alexandra Stähli, PD Dr. med. dent.","CONTACT","+41 31 684 06 00","alexandra.staehli@unibe.ch",{"name":36,"role":32,"phone":33,"phoneExt":28,"email":37},"Jean-Claude Imber, PD Dr. med. dent.","jean-claude.imber@unibe.ch",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department of Periodontology, University of Bern","RECRUITING","Bern","Canton of Bern","3010","Switzerland","CH",{"type":48,"coordinates":49},"Point",[50,51],7.44744,46.94809,{"lat":51,"lon":50},[54,57],{"name":55,"role":32,"phone":56,"phoneExt":28,"email":34},"Alexandra Stähli, MD","+41316840729-",{"name":58,"role":32,"phone":59,"phoneExt":28,"email":37},"Jean-Claude Imber, MD","+41 31 632 35 51",{"type":61,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100646222","evaluation-of-the-anti-septic-effect-of-a-chlorhexidine-chx-mouthwash-with-or-without-an-anti-discoloration-system-ads-during-experimental-gingivitis-100646222",false,"NCT07696364","Chlorhexidine (CHX) Mouthwash With or Without an Anti-Discoloration System (ADS) During Experimental Gingivitis","Protocol Title Evaluation of the Anti-septic Effect of a Chlorhexidine (CHX) Mouthwash With or Without an Anti-Discoloration System (ADS) Compared to Placebo, During Experimental Gingivitis","Inclusion Criteria:\n\n* systemically healthy,\n* non-smoker, former smokers \\> 5 years,\n* at least 24 teeth,\n* clinical diagnosis of periodontal health or gingivitis as determined by pocket probing depth not exceeding 4 mm with concomitant bleeding on probing.\n\nExclusion Criteria:\n\n* clinically visible carious lesions,\n* systemic antibiotics within 3 months prior to enrolment\n* vulnerable persons",true,"ALL","18 Years","40 Years",{"count":74,"type":75},33,"ESTIMATED","INTERVENTIONAL",[78],"NA","Recently, a chlorhexidine product with an anti-discoloration system (ADS) was launched in the market. A comparative study was done to confirm the effectiveness of 0.2% chlorhexidine with ADS. The study was single-blinded. In the experimental period, volunteers maintained their usual oral hygiene habits, besides, they rinsed twice daily with mouthwash (0.2% chlorhexidine) with or without ADS. Obviously, subject's home oral hygiene may become a major confounder of plaque accumulation. Although the effect of ADS is statistically significant, the ability of this new product to prevent plaque accumulation and gingivitis remained highly questionable.\n\nHence, controversy exists about the clinical efficacy of the chlorhexidine products with ADS. Consequently, a clinical validation of such products appears necessary. In the present study, the 21-day experimental gingivitis model will be used. This model is an established non-invasive model in humans for investigating the induction and resolution of inflammation in response to increasing bacterial accumulation. The design enables a study to be performed over 35 days in a well-controlled manner. So far, it is the most accurate clinical study model to access how medication or compounds in dentifrices affect plaque accumulation and gingival inflammation.",[81],"Gingivitis Infection",[83,84,85],"experimental gingivitis","gingivitis model","mouth-rinses with anti-discoloration system","2026-08-07",{"date":88,"type":89},"2026-08-12","ACTUAL",{"date":91,"type":89},"2026-08-03",{"date":93,"type":75},"2027-08-07",{"name":5,"class":6},1]