[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598452":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":28,"interventions":40,"overallOfficials":17,"centralContacts":50,"locations":17,"responsibleParty":56,"collaborators":17,"id":60,"slug":17,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":17,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":17,"maxAge":17,"enrollmentInfo":67,"targetDuration":17,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":86,"whyStopped":17,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":17},{"fullName":5,"class":6},"Minia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"postoperative pain intensity","Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where \"0\" means no pain and \"10\" means a severe pain that has never faced before.\n\nPatients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.","6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.",{"measure":14,"description":15,"timeFrame":16},"Flare-Up Incidence","Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place.\n\nThis could require an unscheduled emergency visit or prescription of additional medication.","Within 7 days post-treatment",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of two parallel groups. Each group will receive a different intracanal medicament following root canal treatment. Postoperative pain and flare-up incidence will be assessed and compared between the two groups.","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":26},"SINGLE","Participants will be blinded to the type of intracanal medicament used during their root canal treatment. The medicaments will be applied in a manner that prevents participants from identifying which treatment they received.",[27],"PARTICIPANT",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Calcium Hydroxide Group (GROUP I)","EXPERIMENTAL","Treated using calcium hydroxide as an intracanal medicament (n=28)",[34],"Drug: Calcium Hydroxide Intracanal medication",{"label":36,"type":31,"description":37,"interventionNames":38},"Bioceramic Group (GROUP II)","treated using bio-ceramic based material as an intracanal medicament (n=28)",[39],"Drug: bioceramic based intracanal medication",[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":17},"DRUG","Calcium Hydroxide Intracanal medication","Treated using calcium hydroxide based material as an intracanal medicament",[30],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":17},"bioceramic based intracanal medication","treated using bio-ceramic based material as an intracanal medicament",[36],[51],{"name":52,"role":53,"phone":54,"phoneExt":17,"email":55},"Abdulrahman Issam Marie","CONTACT","+201069060274","mr.marie98@gmail.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Abdulrahman Issam Abdulkareem Marie","Postgraduate Student, Department of Endodontics","100598452",false,"NCT07071675","Postoperative Pain and Flare-Up Rates in Diabetic Type II Patients Following The Use of Bioceramic Intracanal Medication","Postoperative Pain and Flare-Up Incidence Following the Use of Bio Ceramic Based Intra-Canal Medication in Diabetic Type II Patients (A Randomized Clinical Trial)","Inclusion Criteria:\n\n* Patients with controlled diabetes mellitus type II.\n* Necrotic single rooted teeth:\n\n  * with periapical lesion ranging (1-2mm) in diameter.\n  * with complete root formation.\n  * Without calcified root canals.\n  * Without root caries.\n  * Without external or internal root resorption.\n  * Without anatomical abnormalities such as fusion.\n\nExclusion Criteria:\n\n* Pregnant females.\n* Patients with other systemic diseases in combination with diabetes mellitus.\n* Patients under antibiotic or analgesic administration.\n* Patients with facial swelling.\n* Teeth that are not indicated for endodontic treatment: bad oral hygiene, mobile teeth, or recessed teeth.\n* Previously endodontically treated teeth.\n* Teeth with sinus tract.","ALL",{"count":68,"type":69},56,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this randomized clinical trial is to evaluate the Postoperative Pain and Flare-Up incidence following the use of Bio-Ceramic Based Intra-Canal Medication in Diabetic type II Patients compared to the Calcium Hydroxide based Intra-canal medicament.\n\nThe main questions it aims to answer are:\n\n1. Is there any difference between using the two intracanal medicaments in the aspects of postoperative pain and flare-up incidence in diabetic type II patients?\n2. Do intracanal medications reduce postoperative pain and flare-up incidence in diabetic type II patients?\n\nParticipants will be divided into two groups:\n\n( both groups will receive root canal treatment in single rooted teeth) then: First group: will receive \"Calcium Hydroxide based\" intracanal medicament Second group: will receive \"Bio-Ceramic Based\" intracanal medicament\n\nPostoperative pain will be assessed using:\n\n* visual analog scale (VAS), A scale from (0 to 10) where \"0\" means no pain and \"10\" means a severe pain that has never faced before.\n* Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.\n\nFlare-up is assessed:\n\n\\- by asking the patient to notify the investigator if any sudden severe pain or swelling takes place.",[75,76,77,78],"Postoperative Pain","Flare Up, Symptom","Flare up","Diabete Type 2",[80,81,82,83,84,85],"postoperative pain","flare up","diabetes type II","Intra-Canal medication","bioceramic","calcium hydroxide","NOT_YET_RECRUITING","2025-07-16",{"date":89,"type":90},"2025-07-20","ACTUAL",{"date":92,"type":69},"2025-09-01",{"date":94,"type":69},"2026-09",{"name":5,"class":6}]