[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Dentsply Sirona Implants and Consumables","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Endodontic sealer material with a modified formula","EXPERIMENTAL","Investigation medical Device 1 (IMD1). Endodontic sealer material with a modified formula compared to the predicate.",[13],"Device: AH Plus Jet® Endodontic Sealer",{"label":15,"type":16,"description":17,"interventionNames":18},"Predicate device","ACTIVE_COMPARATOR","Investigation medical Device 2 (IMD2). Predicate endodontic sealer material.",[19],"Device: AH Plus Jet® Root Canal Sealing Material",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","AH Plus Jet® Endodontic Sealer","AH Plus® endodontic sealer is a class IIa medical device used for permanent obturation of root canals of teeth of the secondary dentition in combination with root canal points, for subjects in need of endodontic treatment to restore a tooth.\n\nAH Plus Jet® Endodontic Sealer has similar intended use and the same indications for use as the predicate Root Canal Sealer (AH Plus Jet® Root Canal Sealing Material). However, there are minor differences in the technological characteristics.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"AH Plus Jet® Root Canal Sealing Material","AH Plus® endodontic sealer is a class IIa medical device used for permanent obturation of root canals of teeth of the secondary dentition in combination with root canal points, for subjects in need of endodontic treatment to restore a tooth.\n\nAH Plus Jet® Root Canal Sealing Material is a predicate to AH Plus Jet® Endodontic Sealer.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mikaela Friberg","CONTACT","+46 702 644 357","mikaela.friberg@dentsplysirona.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Ulrika Bonander","+46 706 440 844","ulrika.bonander@dentsplysirona.com",[42],{"facility":43,"status":26,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"New York University College of Dentistry","New York","10010","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.00597,40.71427,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":26,"phoneExt":26,"email":26},"Matthew Malek",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100642378","clinical-performance-of-ah-plus-jet-root-canal-sealers-in-single-cone-protocols-100642378",false,"NCT07642284","Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone Protocols","A Prospective, Parallel-group, Randomized Clinical Investigation Evaluating Performance and Safety of the AH Plus Jet® Sealing Materials Used in Single-cone Technique for Single Visit Endodontic Treatment. A 2-year Follow-up Study","Inclusion Criteria:\n\n1. Adult aged 18-75 at time of informed consent.\n2. Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation.\n3. Subject willing to return for follow-up visits.\n4. Subject has signed and dated the informed consent form.\n5. Subject in need of one or two primary root canal treatment on mature permanent anterior (incisor or canine) or premolar tooth.\n6. Planned study tooth has a favorable prognosis for the next 2 years.\n\nExclusion Criteria:\n\n1. History of allergic reaction to epoxy resins or amines or any of the other product components.\n2. Subject has significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6).\n3. Known pregnancy or is breastfeeding at time of enrolment or at the RCT visit.\n4. Subject unlikely to comply with investigational procedures, as judged by the Investigator.\n5. Sign of sinus tract or gingival swelling in the planned study position.\n6. Previous enrolment in the present clinical investigation.\n7. Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).\n8. Participation in another clinical investigation that may interfere with the present clinical investigation.\n9. Subject experiencing an intraoperative condition that may interfere with the evaluation of the investigational root canal sealer.","ALL","18 Years","75 Years",{"count":70,"type":71},130,"ESTIMATED","INTERVENTIONAL",[74],"NA","A prospective, parallel-group, randomised, post-market clinical follow-up investigation evaluating the performance and safety of the modified formula of the AH Plus Jet® Endodontic Sealer (also referred to as ES) and the predicate AH Plus Jet® Root Canal Sealing material (also referred to as RCS). Around 150 teeth will be randomly assigned to receive either ES or RCS root canal treatment using the single-cone technique. A maximum of 2 teeth per participant will be included and \"tooth\" will be considered the statistical unit and hence considered independent even if the teeth are in the same participant. Participants will be followed up for a period of 24 months to assess the outcomes.",[77],"Root Canal Treatment","NOT_YET_RECRUITING","2026-06-15",{"date":81,"type":82},"2026-06-16","ACTUAL",{"date":84,"type":71},"2026-05-30",{"date":86,"type":71},"2029-03-30",{"name":5,"class":6},1]