[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578298":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":52,"collaborators":33,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":33,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":33,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":82,"whyStopped":33,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulpotomy using Chitosan","EXPERIMENTAL","Chitosan is a natural cationic polysaccharide polymer obtained from chitin deacetylation. It is a linear biopolymer consisting of 2-amino-2-deoxy-β-D-glucose (60-100%) and 2-acetamino -2-deoxy-β-D-glucoside (0-50%) bound together by ß (1→4) bonds. It is biocompatible and has antibacterial, anti-inflammatory and hemostatic properties.",[13],"Procedure: Pulpotomy using Chitosan liquid",{"label":15,"type":16,"description":17,"interventionNames":18},"Pulpotomy using Formocresol","ACTIVE_COMPARATOR","Buckley's formocresol is composed of 31% water base, 15% glycerin to prevent formaldehyde from polymerizing to paraformaldehyde, 19% formaldehyde as an alkylating agent, and 35% tricresol as a protein-coagulating phenolic substance. A 1:5 concentration of Buckley's formocresol is used in this trial.",[19],"Procedure: Pulpotomy using Formocresol",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Pulpotomy using Chitosan liquid","1. After complete hemostasis, a cotton pellet damp with chitosan liquid will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet.\n2. Tooth will be restored with stainless steel crown.",[9],[27],"Chitosan Pulpotomy",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"1. After complete hemostasis, a cotton pellet damp with formocresol will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet.\n2. Tooth will be restored with stainless steel crown.",[15],[32],"Formocresol Pulpotomy",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Reem I Helmi","CONTACT","(+20) 1151806686","reem.helmi@dentistry.cu.edu.eg",[41],{"facility":42,"status":33,"city":43,"state":33,"zip":33,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":33},"Faculty of Dentistry, Cairo University","Cairo","Egypt","EG",{"type":47,"coordinates":48},"Point",[49,50],31.24967,30.06263,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Reem Ibrahim Helmi","Principal Investigator","100578298","clinical-and-radiographic-evaluation-of-chitosan-versus-formocresol-after-vital-pulpotomy-of-primary-molars-100578298",false,"NCT06809478","Clinical and Radiographic Evaluation of Chitosan Versus Formocresol After Vital Pulpotomy of Primary Molars","Clinical and Radiographic Evaluation of Chitosan Versus Formocresol After Vital Pulpotomy of Primary Molars: a Randomized Clinical Study","Inclusion Criteria:\n\n* Healthy cooperative children with at least one deep carious mandibular primary molar indicated for vital pulpotomy.\n* In age range from 4 to 8 years old.\n* Both sexes will be included.\n* Patients with provoked pain.\n* Restorable teeth.\n\nExclusion Criteria:\n\n* Excessive haemorrhage that cannot be stopped by a damp cotton pellet after several minutes.\n* With congenital anomalies in teeth e.g., taurodontism, concrescence or fusion.\n* Patients who show allergic reaction to any material will be used in this trial.\n* Will not be able to stick to follow up protocol in the trial and refuse to give communication data.\n* Patient's guardians refuse to sign up an informed consent before participating in this trial.",true,"ALL","4 Years","8 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to evaluate whether Chitosan liquid will show similar clinical and radiographical success rate compared to Formocresol when used in vital pulp therapy in primary molars.\n\nThe main question it aims to answer is:\n\n* Will Chitosan liquid, in comparison to Formocresol, show similar clinical outcomes in relation to presence\u002Fabsence of post-operative pain, swelling, sinus and\u002For fistula formation when used in vital pulpotomy in primary molars?\n* Will Chitosan liquid, in comparison to Formocresol, show similar radiographical outcomes in relation to presence\u002Fabsence of furcal involvement, periapical lesion, pathological root resorption and\u002For widening of periodontal membrane space when used in vital pulpotomy in primary molars?\n\nFollowing conventional pulpotomy procedure, the primary investigator will evaluate the effect of placing a cotton pellet damp with Chitosan liquid directly on radicular vital pulp compared to that of placing a cotton pellet damp with Formocresol on radicular vital pulp.\n\nPrimary teeth included in both arms of the study will be restored by zinc oxide and eugenol and covered by a stainless steel crown as final restoration.\n\nThe clinical trail will be followed up for 1 year. Clinical outcomes will be evaluated every 3 months. Radiographic outcomes will be evaluated every 6 months.",[75,76],"Pulpitis - Reversible","Pulpotomy",[78,79,80,81],"pulpotomy","formocresol","chitosan","primary molars","NOT_YET_RECRUITING","2025-02-01",{"date":85,"type":86},"2025-02-05","ACTUAL",{"date":88,"type":69},"2025-04",{"date":90,"type":69},"2026-07",{"name":5,"class":6},1]