[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521483":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":45,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":41,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":41,"enrollmentInfo":76,"targetDuration":41,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":48,"whyStopped":41,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Ostergotland County Council, Sweden","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Control- no adjunctive treatment","One arm is the control: two quadrants per each patient treated with non-surgical periodontal treatment alone. NO adjunctive treatment with emdogain. The two quadrants are randomized.",[12],"Procedure: Non-surgical periodontal treatment",{"label":14,"type":15,"description":16,"interventionNames":17},"Test-adjunctive treatment with Emdogain","EXPERIMENTAL","The experimental arm is the two quadrants per patient assigned to be treated vid adjunctive Emdogain.",[18,12],"Device: Enamel matrix derivate",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Enamel matrix derivate","'Applying Enamel matrix derivate in the periodontal pockets after completing the non-surgical periodontal treatment",[14],[26],"Emdogain",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Non-surgical periodontal treatment","No additional\u002Fadjunctive treatment with Emdogain",[9,14],[9],[34],{"name":35,"affiliation":5,"role":36},"Shariel Sayardoust, PhD, DDS","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","+46 (0) 736564648",null,"shariel.sayardoust@regionostergotland.se",{"name":44,"role":39,"phone":41,"phoneExt":41,"email":41},"Carin Starkhammar Johansson, PhD, DDS",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":41},"Centre for Oral Rhabilitation","RECRUITING","Linköping","Region Östergötland","58185","Sweden","SE",{"type":55,"coordinates":56},"Point",[57,58],15.62157,58.41086,{"lat":58,"lon":57},{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Shariel Sayardoust","Associate professor and Senior Consultant in Periodontology",[64],{"name":65,"class":66},"Region Jönköping County","OTHER_GOV","100521483","effectiveness-of-adjunctive-therapy-of-emdogainfl-in-non-surgical-periodontal-treatment-100521483",false,"NCT06070181","Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment","\"Effectiveness of Emdogain® As an Adjunctive Therapy for Non-Surgical Periodontal Treatment- a Randomized, Controlled, Split-Mouth Design Multicenter Clinical Trial\"","Inclusion Criteria:\n\nStudy Population The study population will consist of patients affected by Stage 3 or 4 periodontitis. See below for a full list of inclusion and exclusion criteria.\n\nInclusion Criteria\n\nPatients must meet all of the following criteria for inclusion in the study:\n\n* Over 18 years old\n* Stage 3 or 4 periodontitis\n* Residual pockets with probing depths from 5mm to 9mm with no furcation involvement and adequate plaque control\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria are not allowed to be included in the study:\n\n* Antibiotic treatment in last 3 months\n* Subgingival scaling and root planning performed in last 12 months\n* Patients for which the use of Emdogain® is contraindicated i. e. patients with uncontrolled diabetes or other uncontrolled systemic diseases, disorders or treatments that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy and infections or vascular impairment at the surgical site.","ALL","18 Years",{"count":77,"type":78},150,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this clinical trial is to assess the safety and effectiveness of adjunctive Emdogain® therapy in non-surgical periodontal treatment for patients with stage 3 and 4 periodontitis.\n\nThe main questions it aims to answer are:\n\n* Will adjunctive treatment with Emdogain® result in a greater reduction in Bleeding on Probing and probing pocket depth compared to non-surgical periodontal treatment alone? • Will adjunctive treatment with Emdogain® lead to a greater mean Radiographic attachment level (rAL) gain per quadrant compared to non-surgical periodontal treatment alone?\n* Will adjunctive treatment with Emdogain® result in a lower proportion of treated teeth requiring surgery (PPD ≥6mm) at 12 months after treatment?\n\nParticipants in the study will undergo the following tasks:\n\n* Screening and randomization\n* Receival of non-surgical periodontal treatment in all quadrants and in two quadrants adjunctive Emdogain®\n* 6-month follow-up assessment\n* 12-month follow-up assessment\n\nClinical and radiological assesment will be performed in two quadrants treated with adjunctive Emdogain® therapy and two quadrants treated with non-surgical periodontal treatment alone. This comparison will help determine the effects of adjunctive therapy with Emdogain®.\n\nThe study aims to provide insights into the safety and efficacy of adjunctive Emdogain® therapy in non-surgical periodontal treatment, specifically in patients with stage 3 and 4 periodontitis.",[84],"Periodontitis",[86,87,88,22,89],"non-surgical treatment","Periodontal treatment","Periodontitis stage 3 and 4","Emdogain flapless","2024-10-29",{"date":92,"type":93},"2024-10-31","ACTUAL",{"date":95,"type":93},"2024-03-01",{"date":97,"type":78},"2026-08-01",{"name":5,"class":6},1]