[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545314":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":30,"collaborators":25,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":25,"eligibilityCriteria":40,"healthyVolunteers":41,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":25,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":25,"overallStatus":54,"whyStopped":25,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":25},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NeoMTA","ACTIVE_COMPARATOR","Trained dentists will perform the primary molar pulpotomy following a standardized protocol. After amputation of the coronal pulp, the pulp chamber will be filled with NeoMTA 2. Tooth will be then restored with an appropriately sized stainless steel crown cemented with a glass ionomer cement at the same visit. Follow-up visits will be scheduled at 1, 6, 12 and 24 months after the procedure to assess the success rate of primary molars pulpotomy.",[13],"Other: Primary molars pulpotomies with NeoMTA",{"label":15,"type":16,"description":17,"interventionNames":18},"NeoPUTTY","EXPERIMENTAL","Trained dentists will perform the primary molar pulpotomy following a standardized protocol. After amputation of the coronal pulp, the pulp chamber will be filled with NeoPUTTY. Tooth will be then restored with an appropriately sized stainless steel crown cemented with a glass ionomer cement at the same visit. Follow-up visits will be scheduled at 1, 6, 12 and 24 months after the procedure to assess the success rate of primary molars pulpotomy.",[19],"Other: Primary molar pulpotomies with NeoPUTTY",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Primary molars pulpotomies with NeoMTA","Primary molar pulpotomies will be performed by trained dentists using NeoMTA, a bioactive material containing calcium silicate known for its bio-active and bone forming potential. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess success rate, and clinical and radiographic outcomes",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Primary molar pulpotomies with NeoPUTTY","Primary molar pulpotomies will be performed by trained dentists using NeoPUTTY, a ready to use bioactive material containing calcium silicate. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess success rate, and clinical and radiographic outcomes",[15],{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Beatriz Ferraz dos Santos","Clinician-scientist; Research director","100545314","outcomes-of-neomta-and-neoputty-pulpotomies-in-primary-molars-100545314",false,"NCT06380296","Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars","Clinical and Radiographic Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Healthy children aged between 3 and 10 years\n* Primary molars with no history of spontaneous or persistent pain\n* Restorable primary molars with deep carious lesions approximating or reaching the pulp\n* Primary molars with at least 2\u002F3rd of the root length present\n* Radiographically, the inclusion criteria were as follows: deep dentin caries approximating or reaching the pulp; no more than one-third of physiologic root resorption; no widening of the periodontal ligament (PDL) space; no pathologic internal or external root resorption; and no apical or furcal radiolucency.\n* Children who can understand and speak French or English.\n\nExclusion Criteria:\n\n* Primary molars with pathological mobility, tenderness to percussion, swelling, or sinus tract\n* Primary molars without hemostasis after coronal pulp amputation within five minutes.\n* Primary molars with widening of the periodontal ligament (PDL) space; pathologic internal or external root resorption; and apical or furcal radiolucency",true,"ALL","3 Years","10 Years",{"count":46,"type":47},50,"ESTIMATED","INTERVENTIONAL",[50],"NA","The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications.",[53],"Pulp Disease, Dental","NOT_YET_RECRUITING","2024-04-18",{"date":57,"type":58},"2024-04-23","ACTUAL",{"date":60,"type":47},"2024-04",{"date":62,"type":47},"2027-03",{"name":5,"class":6}]