[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615241":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Fujairah","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EndoCem Pulpotomy","ACTIVE_COMPARATOR","Participants in this arm will receive a full pulpotomy procedure for the treatment of symptomatic irreversible pulpitis. Following coronal pulp removal and hemostasis, the vital radicular pulp tissue will be covered with the calcium silicate cement EndoCem (ZTM Medicare, Pre-mixed MTA Putty), applied according to the manufacturer's instructions. The tooth will then receive a final restoration. This arm serves as the active comparator, evaluating the standard vital pulp therapy protocol using a modern bioceramic material.",[13],"Device: Calcium Silicate Cement",{"label":15,"type":16,"description":17,"interventionNames":18},"EndoCem + Laser Pulpotomy","EXPERIMENTAL","Participants in this arm will receive an identical full pulpotomy procedure. However, prior to the placement of the EndoCem cement, the exposed radicular pulp stumps will undergo Er,Cr:YSGG laser biomodulation. The laser will be applied in a non-ablative, biostimulatory mode using specific parameters (e.g., 1.0 W, 20 Hz, 50 mJ, 60% water, 70% air) for a predetermined duration to achieve the biomodulation effect. Following laser application, EndoCem cement is placed and the tooth is restored. This is the experimental arm investigating the adjunctive effect of laser therapy.",[13,19],"Device: Er,Cr:YSGG Laser",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Calcium Silicate Cement","A premixed, ready-to-use hydraulic tricalcium silicate cement (commercial name: EndoCem MTA Pre-mixed Putty) used as a direct pulp-capping agent. It is applied over the vital radicular pulp tissue following a pulpotomy procedure to seal the pulp chamber and promote healing and reparative dentin formation. The material is used according to the manufacturer's instructions for vital pulp therapy.",[15,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Er,Cr:YSGG Laser","An Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser system used in a non-ablative, low-level power setting for biomodulation. Following hemostasis in the pulpotomy procedure, the laser tip delivers photonic energy to the exposed pulp stumps in a defocused, non-contact mode. The intended biological effects are biostimulation of pulpal cells, enhanced healing, and anti-inflammatory action, which may reduce postoperative pain. Specific parameters (e.g., power, frequency, air\u002Fwater coolant ratio) are set for therapeutic bio-stimulation rather than surgical cutting.",[15],[32],{"name":33,"affiliation":34,"role":35},"Mohamed Medhat Kataia, PhD","Fujairah University","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Nabeel Ayappali Kalluvalappil, MDS","CONTACT","+97192023517","n.kalluvalappil@fu.ac.ae",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Dental Clinic, College of Dentistry, Fujairah University","RECRUITING","Fujairah","Emirate of Fujairah","2202","United Arab Emirates","AE",{"type":52,"coordinates":53},"Point",[54,55],56.34141,25.11641,{"lat":55,"lon":54},[58],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100615241","postoperative-pain-after-pulpotomy-in-children-using-calcium-silicate-cements-with-and-without-laser-therapy-100615241",false,"NCT07290049","Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy","Evaluation of Postoperative Pain After Pulpotomy Using Calcium Silicate Cements in Permanent Molars With and Without Laser Biomodulation: A Randomized Clinical Trial","Inclusion Criteria:\n\nPatients between 9 and 14 years of age. Must have a two-rooted mandibular molar tooth (lower back tooth). The tooth must be diagnosed with symptomatic irreversible pulpitis (a painful, inflamed nerve).\n\nThe tooth must be considered restorable (can be fixed with a filling or crown). Patient and\u002For guardian must be able to understand and sign the informed consent form.\n\nThe tooth must be periodontally healthy, with no mobility, and not painful to tapping or pressing.\n\nExclusion Criteria:\n\nTeeth with immature root tips. Teeth that are not restorable (severely damaged or decayed). Bleeding from the tooth's nerve that cannot be controlled within 10 minutes during the procedure.\n\nPatients with significant medical conditions that could complicate dental treatment.\n\nTeeth with a dead (necrotic) nerve. Inability or unwillingness to provide informed consent. Individuals from vulnerable groups (as defined by the ethics committee).","ALL","9 Years","14 Years",{"count":72,"type":73},46,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study is for children and young adults who have a severe toothache in a permanent back molar, caused by an inflamed nerve (a condition called irreversible pulpitis). Usually, the treatment for this is a root canal, which removes the entire nerve. However, a different treatment called \"vital pulp therapy\" or \"pulpotomy\" may be an option. This simpler procedure removes only the infected part of the nerve, leaving the healthy part alive, and then seals the tooth with a special material.\n\nThe goal of our research is to see if we can make this pulpotomy procedure even more comfortable for patients afterward. We are testing two approaches:\n\nUsing a modern dental filling material called EndoCem to seal the tooth.\n\nUsing the same EndoCem material, but first applying a gentle laser to the healthy nerve tissue. This laser treatment, known as \"biomodulation,\" is thought to help calm the tissue and improve healing.\n\nPatients who join the study will be randomly assigned to one of these two treatment groups. The main thing we will measure is the level of pain after the procedure, which patients will record on a simple pain scale. We want to find out if using the laser in addition to the filling material leads to less pain and a better experience after the treatment.\n\nThis study will help dentists understand if combining this new sealing material with laser therapy can be a more effective and comfortable way to save a tooth with a severe toothache.",[79,80],"Symptomatic Irreversible Pulpitis","Symptomatic Irreversible Pulpitis (SIP)",[82,83,84,85,23,86,87,28,88,89,90],"Vital Pulp Therapy","Pulpotomy","Irreversible Pulpitis","Postoperative Pain","Bioceramic","Laser Biomodulation","EndoCem","Biodentine","Randomized Controlled Trial","2025-12-04",{"date":93,"type":94},"2025-12-17","ACTUAL",{"date":96,"type":94},"2025-04-24",{"date":98,"type":73},"2026-01-25",{"name":5,"class":6},1]