[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600709":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":12,"responsibleParty":30,"collaborators":12,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":12,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":12,"enrollmentInfo":43,"targetDuration":12,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":54,"overallStatus":62,"whyStopped":12,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":12},{"fullName":5,"class":6},"Cairo University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"No medication","NO_INTERVENTION","Osseous cavity left with no medication after root end resection",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Different types of medications placed in the osseous cavity after root end resection","EXPERIMENTAL","I1: Diclofenac sodium : 1 mL of gel, of 1 mL of 3 mL\u002F75 mg Diclofenac sodium and 1% Carbopol 940 gel base, will be passively placed in the osseous cavity I2: Hyaluronidase : 1 mL of gel, of 1 ampoule (1500 IU) Hyalase powder in 2.5 mL of 0.9% sodium chloride, and 1% Carbopol 940 gel base, will be passively placed in the osseous cavity I3: Diclofenac sodium and Hyaluronidase: 1 mL of gel, of 1 ampoule (1500 IU) Hyalase powder and 1 ampoule (3 mL\u002F75 mg) of Diclofenac sodium, Carbopol 940 gel base, will be passively placed in the osseous cavity",[18],"Drug: Diclofenac Sodium Gel",[20],{"type":21,"name":22,"description":16,"armGroupLabels":23,"otherNames":12},"DRUG","Diclofenac Sodium Gel",[14],[25],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Mariam Hesham Mahmoud Eissa, MSc","CONTACT","00201001714432","mariam.abdelfattah@dentisrty.cu.edu.eg",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Mariam Hesham Mahmoud Abdelfattah Eissa","Principle investigator","100600709","effect-of-local-use-of-non-steroidal-anti-inflammatory-agent-diclofenac-sodium-with-and-without-hyaluronidase-on-post-surgical-pain-and-swelling-100600709",false,"NCT07101016","Effect of Local Use of Non-steroidal Anti-inflammatory Agent (Diclofenac Sodium) With and Without Hyaluronidase on Post-surgical Pain and Swelling","Effect of Local Use of Non-steroidal Anti-inflammatory Agent (Diclofenac Sodium) With and Without Hyaluronidase on Post-surgical Pain and Swelling: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II, with no known allergic manifestations to the drugs used in the study and no involvement with other medication during the study (Appendix 2).\n2. Patients who are 18 years of age or older, without underlying chronic systemic conditions.\n3. Male and female patients.\n4. Patients having asymptomatic single rooted teeth with periapical lesions 5-10mm in diameter (Appendix 3).\n5. Patients who can understand the visual analogue scale (Appendix 4).\n6. Patients who accept to participate in the trial and can sign the informed consent (Appendix 1).\n\nExclusion Criteria:\n\n* 1\\. Teeth with pathosis associated with vertical root fractures, teeth with coronal perforations, and periodontal pockets (7 mm).\n\n  2\\. Miller class III\u002FIV mobility, compromised crown-to-root ratio, combined endodontic-periodontic lesions 3. Systemic medical diseases and autoimmune diseases 4. Pregnant females 5. Patients allergic to Diclofenac or Hyaluronidase 6. Teeth with previous root canal therapy","ALL","18 Years",{"count":44,"type":45},44,"ESTIMATED","INTERVENTIONAL",[48],"NA","The goal of this clinical trial is to evaluate whether locally applied diclofenac sodium, with or without hyaluronidase, can reduce post-surgical pain and swelling in adult male and female patients (18 years or older) with asymptomatic single-rooted teeth and periapical lesions (5-10 mm in diameter). The main questions it aims to answer are:\n\nDoes local application of diclofenac sodium reduce postoperative pain and swelling compared to no medication?\n\nDoes the combination of diclofenac sodium and hyaluronidase offer greater reduction in postoperative pain and swelling than diclofenac sodium alone?\n\nResearchers will compare four groups (diclofenac only, hyaluronidase only, diclofenac + hyaluronidase, and no medicament) to see if the medicated groups experience significantly less pain and swelling after periapical surgery compared to the control group.\n\nParticipants will:\n\nUndergo root canal treatment followed by periapical surgery in a single visit.\n\nReceive a randomly assigned intra-osseous gel (diclofenac, hyaluronidase, both, or none) placed into the surgical cavity.\n\nRecord their postoperative pain using a visual analogue scale at specified intervals (6, 12, 24, 48 hours, and 7 days).\n\nReturn for clinical assessments of swelling at 24, 72 hours, and 5 days post-surgery",[51,52,53],"Root End Resection","Periapical Lesion","Single Rooted Teeth",[55,56,57,58,59,60,61],"Periapical lesion","Single rooted teeth","Post operative pain","Post operative swelling","Root end resection","Hyaluronidase","Diclofenac Sodium","NOT_YET_RECRUITING","2025-07-28",{"date":65,"type":66},"2025-08-03","ACTUAL",{"date":68,"type":45},"2025-08-01",{"date":70,"type":45},"2025-08-08",{"name":32,"class":6}]