[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647847":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":54,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Surgical Guide With External Irrigation","ACTIVE_COMPARATOR","Implant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation.",[13],"Device: Conventional Surgical Guide",{"label":15,"type":16,"description":17,"interventionNames":18},"Irrigation-Integrated Surgical Guide","EXPERIMENTAL","Implant osteotomy and implant placement will be performed using a surgical guide incorporating an internal irrigation channel designed to direct sterile saline to the drill-bone interface.",[19],"Device: Irrigation-Integrated Surgical Guide",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional Surgical Guide","Conventional guided implant osteotomy using external sterile saline irrigation.",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Radi Masri","CONTACT","410 706 8133","rmasri@umaryland.edu",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Hanae Saito","410 706 3646","hsaito@umaryland.edu",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"University of Maryland School of Dentistry","Baltimore","Maryland","21201","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-76.61219,39.29038,{"lat":52,"lon":51},{"type":55,"investigatorFullName":32,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Professor","100647847","internal-irrigation-surgery-100647847",false,"NCT07715825","Internal Irrigation Surgery","Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery","Inclusion Criteria:\n\n1. Patients aged 25+\n2. Patients requiring a dental implant in the maxilla or mandible\n3. Patients with sufficient bone volume for implant placement.\n4. Patients classified as ASA I or II based on the American Society of Anesthesiologists (ASA) physical status classification system.\n5. Patients capable of providing informed consent and willing to adhere to study procedures and follow-up appointments.\n6. Patients with adequate interarch space to accommodate guided implant surgery.\n7. No history of implant placement at the experimental or control site.\n\nExclusion Criteria:\n\n1. ASA class 3 or higher\n2. Currently undergoing or history of bisphosphonate or antiresorptive therapy\n3. Patients who have received prior radiation therapy to the head and neck.\n4. Patients with contraindications for implant placement, such as active infections or severe periodontal disease.\n5. Pregnant or breastfeeding\n6. Patients with psychiatric or cognitive conditions impairing informed consent or compliance",true,"ALL","25 Years","75 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","Heat generated during osteotomy and implant placement may cause thermal injury to bone and adversely affect healing and osseointegration. External irrigation is commonly used to reduce heat generation; however, cooling may be less effective at the drill-bone interface, particularly during guided implant surgery.\n\nSurgical guides with integrated irrigation channels have been developed to deliver coolant more directly to the osteotomy site, but clinical evidence regarding their effectiveness remains limited. This study will evaluate whether an internal irrigation surgical guide system reduces heat generation during osteotomy compared with a conventional guided implant surgery approach. The study will also assess clinical outcomes associated with implant placement. The findings may help inform safer and more effective protocols for guided dental implant surgery.",[76,77,78,79],"Dental Implant Healing","Partial Edentulism Class 1","Partial Edentulism Class II","Partial Edentulism Class 3",[81,82],"dental implant surgery","dental implant placement","NOT_YET_RECRUITING","2026-08-03",{"date":86,"type":87},"2026-08-06","ACTUAL",{"date":89,"type":70},"2026-09-01",{"date":91,"type":70},"2028-12-31",{"name":5,"class":6},1]