[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589516":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":54,"locations":61,"responsibleParty":127,"collaborators":129,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":10,"enrollmentInfo":145,"targetDuration":10,"studyType":148,"phases":10,"briefSummary":149,"conditions":150,"keywords":154,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Septodont","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Temporary teeth treated in restorative treatment",null,"For temporary teeth treated in restorative treatment arm, the following restoration indications will be found :\n\n* In the crown\n* Permanent dentine restoration (including under composites or Inlay\u002FOnlay)\n* Enamel restoration for up to 6 months\n* Restoration of deep and\u002For large coronal carious lesions\n* Restoration of cervical or radicular lesions\n* On the pulp\n* Direct pulp capping\n* Indirect pulp capping\n* Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes",[13],"Device: Dental restorative or endodontic treatment requiring Biodentine XP use",{"label":15,"type":10,"description":16,"interventionNames":17},"Permanent (mature or immature) teeth treated in restorative treatment.","For permanent (mature or immature) teeth treated in restorative treatment arm, the following restoration indications will be found :\n\n* In the crown\n* Permanent dentine restoration (including under composites or Inlay\u002FOnlay)\n* Temporary dentine-enamel restoration (for up to six-months)\n* Restoration of deep and\u002For large coronal carious lesions\n* Restoration of cervical or radicular lesions\n* On the pulp\n* Direct pulp capping\n* Indirect pulp capping\n* Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Permanent (mature or immature teeth) treated in endodontic treatment.","For permanent (mature or immature) teeth treated in endodontic treatment arm, the following endodontic indications will be found :\n\nFor permanent teeth (immature or mature):\n\n* Repair of root perforations\n* Repair of furcation perforations\n* Repair of perforating internal resorption\n* Repair of external resorption\n* Root-end filling in endodontic surgery (retrograde filling)\n\nFor immature permanent teeth with necrotic pulp:\n\n* Apexification\n* Revitalization procedure relying on root canal revascularisation.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","Dental restorative or endodontic treatment requiring Biodentine XP use","In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.",[19,15,9],[29,33,36,39,42,45,48,51],{"name":30,"affiliation":31,"role":32},"Dr Katia Jedeon","Hôpital Rotschild","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Pr Marjorie Zanini","Hôpital Pitié Salpêtrière",{"name":37,"affiliation":38,"role":32},"Pr Marie-Agnès Gasqui De Saint Joachim","Hôpital HCL lyon",{"name":40,"affiliation":41,"role":32},"Dr. Alexis Gaudin","Nantes University Hospital",{"name":43,"affiliation":44,"role":32},"Dr Justine Le Clerc","CHRU Rennes",{"name":46,"affiliation":47,"role":32},"Dr Sandrine DAHAN","Cabinet dentaire",{"name":49,"affiliation":50,"role":32},"Pr Joseph Sabbagh, DDS, MSc, PhD, HDR, FICD","Queen Astrid Dental Practice",{"name":52,"affiliation":53,"role":32},"Pr. Simon Mariano PEDANO DE PIERO, DDS, PhD","UZ Leuven",[55],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},"Clinical Operations Medical Affairs Department","CONTACT","1 49 76 70 00","+33","clinical-operations@septodont.com",[62,73,81,92,100,108,113,118],{"facility":50,"status":63,"city":64,"state":10,"zip":10,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":10},"RECRUITING","Kraainem","Belgium","BE",{"type":68,"coordinates":69},"Point",[70,71],4.46946,50.86155,{"lat":71,"lon":70},{"facility":74,"status":63,"city":75,"state":10,"zip":10,"country":65,"countryCode":66,"cosmosGeoPoint":76,"geoPoint":80,"contacts":10},"UZ Leuven - University hospital","Leuven",{"type":68,"coordinates":77},[78,79],4.70093,50.87959,{"lat":79,"lon":78},{"facility":82,"status":63,"city":83,"state":10,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":10},"HCL Lyon","Lyon","69002","France","FR",{"type":68,"coordinates":88},[89,90],4.84789,45.74906,{"lat":90,"lon":89},{"facility":47,"status":63,"city":93,"state":10,"zip":94,"country":85,"countryCode":86,"cosmosGeoPoint":95,"geoPoint":99,"contacts":10},"Nantes","44093",{"type":68,"coordinates":96},[97,98],-1.55336,47.21725,{"lat":98,"lon":97},{"facility":47,"status":63,"city":101,"state":10,"zip":102,"country":85,"countryCode":86,"cosmosGeoPoint":103,"geoPoint":107,"contacts":10},"Paris","75008",{"type":68,"coordinates":104},[105,106],2.3488,48.85341,{"lat":106,"lon":105},{"facility":31,"status":63,"city":101,"state":10,"zip":109,"country":85,"countryCode":86,"cosmosGeoPoint":110,"geoPoint":112,"contacts":10},"75012",{"type":68,"coordinates":111},[105,106],{"lat":106,"lon":105},{"facility":35,"status":63,"city":101,"state":10,"zip":114,"country":85,"countryCode":86,"cosmosGeoPoint":115,"geoPoint":117,"contacts":10},"75013",{"type":68,"coordinates":116},[105,106],{"lat":106,"lon":105},{"facility":119,"status":63,"city":120,"state":10,"zip":121,"country":85,"countryCode":86,"cosmosGeoPoint":122,"geoPoint":126,"contacts":10},"CHU Rennes","Rennes","35000",{"type":68,"coordinates":123},[124,125],-1.67431,48.11109,{"lat":125,"lon":124},{"type":128,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[130,133],{"name":131,"class":132},"DOCAPOST","UNKNOWN",{"name":134,"class":6},"Axonal-Biostatem","100589516","clinical-investigation-measuring-the-long-term-clinical-performance-and-safety-of-biodentine-xp-in-patients-treated-for-coronal-restorative-or-endodontic-dental-indications-100589516",false,"NCT06955429","Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.","Observational, Prospective, International and Multicenter Clinical Investigation Measuring the Longterm Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.","BIOD XP","Inclusion Criteria:\n\n1. Temporary tooth, from a child ≥ 2 years old, requiring dental restorative treatment with Biodentine™ XP, and\u002For, Permanent (mature or immature) tooth, from a child or an adult, requiring a dental restorative and\u002For an endodontic treatment with Biodentine™ XP.\n2. Adult patient with a signed informed consent form; For the minor, if in age to understand, an assent is required, and at least one parent or legal representative must consent.\n3. Only in France: Subject affiliated or benefiting from a social\u002Fhealth insurance system.\n\nExclusion Criteria:\n\n1. Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).\n2. Inadequate expected tooth lifetime as estimated by the investigator:\n\n   * For a Temporary tooth: high probability of tooth loss within 2 years after treatment with Biodentine™ XP.\n   * For a permanent tooth: high probability of tooth loss within 10 years after treatment with Biodentine™ XP.\n3. Patient with any systemic disease that may hinder the normal healing process and\u002For the follow-up.\n4. Adult patient under legal protection measures or unable to express his\u002Fher consent, and individual deprived of liberty by judicial or administrative decision, as well as individual receiving psychiatric care.\n5. Periodontitis (stage 3, 4 or stage 2 grade C).\n6. Inability to comply with study procedures.\n7. Participation in another interventional clinical investigation that can induce bias in the study results.","ALL","2 Years",{"count":146,"type":147},275,"ESTIMATED","OBSERVATIONAL","The aim of this present study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in all its indications.",[151,152,153],"Dental Restoration, Permanent","Dental Restorations","Endodontic Treatment",[155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175],"Dentine restoration","Coronal carious lesions","Restoration of cervical lesion","Restoration of radicular lesion","Pulp capping","Pulpotomy","Apexification","Revitalization","Endodontic treatment","Root","Crown","Pulp","Root perforations","Furcation perforations","Perforating internal resorptions","External resorption","Root-end filling","Permanent dentine restoration","Temporary dentine-enamel restoration","Biodentine","Biodentine XP","2026-04-30",{"date":178,"type":179},"2026-05-06","ACTUAL",{"date":181,"type":179},"2025-10-23",{"date":183,"type":147},"2037-02-28",{"name":5,"class":6},8]