[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585624":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":42,"collaborators":45,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":25},{"fullName":5,"class":6},"Qatar University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulpotomy","EXPERIMENTAL","Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpotomy treatment intervention",[13],"Procedure: Pulpotomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Pulpectomy","ACTIVE_COMPARATOR","Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpectomy treatment intervention.",[19],"Procedure: Pulpectomy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Pulpotomy is a conservative pulp treatment option where only the coronal pulp is removed and a bioactive medicament (MTA) is placed over the remnant radicular pulp after haemostasis is achieved.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Pulpectomy is treatment procedure in primary teeth where the entire coronal and radicular pulp is extirpated and the root canal system filled with a resorbable material (Vitapex\u002FMetapex)",[15],[30],{"name":31,"affiliation":5,"role":32},"Nebu Philip, MDS, PhD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","+974-44037319","nphilip@qu.edu.qa",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},"Hani Nazzal, PhD","+974-44037809","hnazzal@hamad.qa",{"type":32,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Nebu Philip","Assistant Professor",[46,48,51,53,56],{"name":47,"class":6},"Jordan University of Science and Technology",{"name":49,"class":50},"Primary Health Care Corporation, Qatar","OTHER_GOV",{"name":52,"class":6},"Cairo University",{"name":54,"class":55},"Christian Dental College","UNKNOWN",{"name":57,"class":55},"Oral and Dental Teaching Hospital, Libya","100585624","treatment-outcomes-of-pulpotomy-versus-pulpectomy-in-vital-primary-molars-diagnosed-with-irreversible-pulpitis-100585624",false,"NCT06904781","Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Irreversible Pulpitis","Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Non-inferiority Randomised Controlled Trial","Inclusion Criteria:\n\n1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.\n2. Participants have symptoms typical of irreversible pulpitis in one of the primary molars.\n3. The pulp of the affected primary molar is vital.\n4. Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.\n5. The affected primary molars can be restored with full coverage stainless steel crowns.\n6. Any physiologic root resorption, if present, is less than ⅓ the root length.\n\nExclusion Criteria:\n\n1. Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis\u002Ffistula, or soft tissue swelling).\n2. Pre-operative periapical radiograph suggests presence of periapical radiolucency or pathologic root resorption.\n3. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular\u002Fminimally bleeding pulp tissue or yellowish necrotic areas\u002Fpurulent exudate).\n4. Signs of extensive radicular pulp inflammation i.e., root pulp bleeding continues even after 6-min.\n5. Parents not willing to place full coverage crowns post-treatment.\n6. Clinical diagnosis of irreversible pulpitis between two adjacent primary molars is not sharply defined.\n7. Unable to perform clinical procedure under rubber dam",true,"ALL","4 Years","9 Years",{"count":70,"type":71},80,"ESTIMATED","INTERVENTIONAL",[74],"NA","This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining the proprioceptive sensation of the tooth - all important advantages when treating young children.",[77],"Irreversible Pulpitis",[15,9,79,80],"Vital primary molars","Irreversible pulpitis","NOT_YET_RECRUITING","2025-04-08",{"date":84,"type":85},"2025-04-11","ACTUAL",{"date":87,"type":71},"2025-07-01",{"date":89,"type":71},"2028-06-30",{"name":5,"class":6}]