[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408974":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":132,"collaborators":136,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":26,"eligibilityCriteria":162,"healthyVolunteers":158,"sex":163,"minAge":164,"maxAge":26,"enrollmentInfo":165,"targetDuration":26,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":177,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Malmö University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1 visit endodontics","EXPERIMENTAL","Root canal treatment is performed in one visit.",[13],"Procedure: 1 visit root canal treatment (endodontics)",{"label":15,"type":16,"description":17,"interventionNames":18},"2 visits endodontics","ACTIVE_COMPARATOR","Root canal treatment is performed in two visits.",[19],"Procedure: 2 visits root canal treatment (endodontics)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","1 visit root canal treatment (endodontics)","Endodontics (root canal treatment). In the enrolment visit, access, opening and identification of root canals can be performed and a suitable temporization will be placed in the tooth if needed. Root canal treatment can be completed in the same visit or performed in another visit where cleaning, shaping and root filling procedures, temporization or permanent restoration will be performed. These procedures are part of the normal clinical praxis. No rigid protocol will be implemented, as a pragmatic design was chosen.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"2 visits root canal treatment (endodontics)","Endodontics (root canal treatment). In the enrolment visit, access, opening and identification of root canals can be performed and a suitable temporization will be placed in the tooth if needed. Root canal treatment can be started, or performed in another visit, lasting 2 visits. In the first visit cleaning and shaping is performed and a medication is put in place in the canals, and the tooth is temporized until the next visit at least one week apart. In the second visit the tooth is root filled and temporization or permanent restoration will be performed. These procedures are part of the normal clinical praxis. No rigid protocol will be implemented, as a pragmatic design was chosen.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Annika Björkner, PhD","CONTACT","+46-(0)40-6658532","annika.bjorkner@mau.se",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Catherine Benavente Hansson, DDS","+46-(0)665 87 95","catherine.benavente-hansson@mau.se",[42,59,77,89,101,112,119],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Folktandvården Region Kronoberg","RECRUITING","Vaxjo","Kronoberg County","352 31","Sweden","SE",{"type":51,"coordinates":52},"Point",[53,54],14.80906,56.87767,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":26,"phoneExt":26,"email":26},"Veronica Asp Lockby",{"facility":60,"status":44,"city":61,"state":62,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Folktandvården Region Norrbotten","Luleå","Norrbotten County","97128",{"type":51,"coordinates":65},[66,67],22.15465,65.58415,{"lat":67,"lon":66},[70,74],{"name":71,"role":34,"phone":72,"phoneExt":26,"email":73},"Fernando Mota de Almeida, PhD","0046-920-71975","fernando.mota-de-almeida@norrbotten.se",{"name":75,"role":34,"phone":26,"phoneExt":26,"email":76},"Elin Lundgren, DDS","elin.s.lundgren@norrbotten.se",{"facility":78,"status":79,"city":80,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Folktandvården Region Kalmar","NOT_YET_RECRUITING","Kalmar",{"type":51,"coordinates":82},[83,84],16.36163,56.66157,{"lat":84,"lon":83},[87],{"name":88,"role":34,"phone":26,"phoneExt":26,"email":26},"Elena Shmarina",{"facility":90,"status":44,"city":61,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Smile Tandvård",{"type":51,"coordinates":92},[66,67],{"lat":67,"lon":66},[95,98],{"name":96,"role":34,"phone":26,"phoneExt":26,"email":97},"Anna Gatu","anna.gatu@smile.se",{"name":99,"role":34,"phone":26,"phoneExt":26,"email":100},"Lars Armbäck, DDS","Lars.armback@smile.se",{"facility":102,"status":79,"city":103,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Aragón Dental","Malmö",{"type":51,"coordinates":105},[106,107],13.00073,55.60587,{"lat":107,"lon":106},[110],{"name":111,"role":34,"phone":26,"phoneExt":26,"email":26},"Veronica Aragón, DDS",{"facility":113,"status":79,"city":103,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Oris Dental",{"type":51,"coordinates":115},[106,107],{"lat":107,"lon":106},[118],{"name":38,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":120,"status":44,"city":121,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Folktandvården Region Halland","Varberg",{"type":51,"coordinates":123},[124,125],12.25078,57.10557,{"lat":125,"lon":124},[128],{"name":129,"role":34,"phone":130,"phoneExt":26,"email":131},"Maria Wattsgård","+46-(0)340-48 23 00","Maria.Wattsgard@regionhalland.se",{"type":133,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Annika E Björkner","Associate Professor",[137,140,142,145,147,149,151,152,153,155],{"name":138,"class":139},"Norrbottens County Council","OTHER_GOV",{"name":141,"class":6},"Landstinget i Kalmar Län",{"name":143,"class":144},"Blekinge County Council","UNKNOWN",{"name":146,"class":139},"Kronoberg County Council",{"name":148,"class":6},"Region Skane",{"name":150,"class":139},"County Council of Halland, Sweden",{"name":90,"class":144},{"name":102,"class":144},{"name":154,"class":6},"Region Kalmar County",{"name":113,"class":144},"100408974","one-vs-two-visits-root-canal-treatments-in-infected-teeth-100408974",false,"NCT04605445","One Vs Two Visits Root Canal Treatments in Infected Teeth","One Vs Two Visits Endodontics - a Prospective Randomized Multicenter Study in General Dental Practice","Inclusion Criteria:\n\n* Patient older than 17 years.\n* Permanent tooth excluding third molars.\n* Necrotic tooth with\u002Fwithout clinical and\u002For radiological signs of apical (juxta radicular) periodontitis (non-bleeding pulp in the canal orifice. In case of a multi rooted tooth, a non-bleeding pulp in at least one root canal orifice) where orthograde endodontic treatment is planned.\n\nExclusion Criteria:\n\n* Patients with severe general disease and\u002F or where endodontic treatment requires special consideration for health reasons (eg radiation-treated jaw bone in the area or increased susceptibility to infection).\n* Systemic involvement (fever).\n* Swelling (extra- and\u002For intra oral).\n* Previously root canal treated tooth (instrumented and\u002For rotfilled).\n* Confirmed or strong suspicion of transverse or longitudinal root fracture.\n* Trauma to the tooth (\\\u003C6 month).\n* Marginal bone loss \\>1\u002F3 of the root lenght.\n* Root resorption.\n* Non restorable tooth.\n* Endodontic treatment is not considered feasible because rubberdam cannot be used on the tooth.\n* Follow-up at the clinic of the treatment after\\> 1 year is considered not feasible.","ALL","18 Years",{"count":166,"type":167},1000,"ESTIMATED","INTERVENTIONAL",[170],"NA","The primary aim of the study is to compare the outcome of one vs two visits endodontics (root canal treatments) performed in general dental practice of infected (necrotic) teeth, one and four years after treatment. Secondary aims are to compare the root filling quality and the frequency of complications for both treatment modalities.\n\nA pilot study will identify the shortcomings of the protocol, which will be revised accordingly.\n\nA multi-center study in several clinics from five counties throughout Sweden is planned. Consecutive eligible patients (see inclusion and exclusion criteria) with one tooth each will be included.\n\nThe study sample size calculation was based on a judgement that a minimal worthwhile effect of less than 10% was not clinically relevant. The presumption was that successful outcomes would be of 75% and 65% for the different treatment arms, respectively. Three hundred and fifty six patients per group are thus needed to detect that difference as statistical significant with a power of 80% and an alfa-error of 5%. To compensate for around 30% drop-outs a number of 1000 patients will be recruited.\n\nPatients will be randomly enrolled in two arms: one in which the endodontic treatment (root canal treatment) is performed in one visit, and in the other arm in two visits. The allocation sequences for one vs multiple visit endodontics will be computer generated followed by a dark colored envelope concealed allocation.\n\nThe patients will be contacted by telephone 5-7 days post-operatively, and a control visit at the clinic will be scheduled one month post-operatively to assess complications related to the treatment.\n\nA clinical control will be performed at the clinic one and four years after treatment. Intra-oral radiographs will be taken. The radiographs will be examined by two blinded and independent observers. A successful outcome is defined by clinical and radiographic normalcy.\n\nThe statistical methods selected to analyse the primary outcome will be the Chi square test of 2x2 tables, or Fisher´s exact test when proportions are small and the expected value \\\u003C5. The calculations will be two-tailed. Results will be considered statistically significant at p\\\u003C0.05.",[173,174,175,176],"Apical Periodontitis","Pain","Tooth Loss","Dental Pulp Necrosis",[178,179,180,181,182],"Endodontics","General Dental Practice","Single Visit","Multiple Visits","Infection Barrier","2024-12-11",{"date":185,"type":186},"2024-12-16","ACTUAL",{"date":188,"type":186},"2020-11-18",{"date":190,"type":167},"2031-12",{"name":5,"class":6},7]