[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715825":3,"trial-entities:NCT07715825":99,"trial-summary:NCT07715825":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":49,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":73,"locations":76,"central_contacts":86,"overall_officials":96,"references":97,"see_also_links":98},"NCT07715825","HP-00119624","Internal Irrigation Surgery","Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery","NOT_YET_RECRUITING","2028-12-31","2026-07","2026-07-20","2026-09-01","University of Maryland, Baltimore","OTHER",false,"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.","Heat generation during osteotomy and implant placement is a critical concern in implant dentistry, as excessive temperatures can lead to bone necrosis, impaired healing, and early implant failure. A temperature increase of 10°C can be considered a threshold for potential issues. Bone cell damage can occur if the temperature reaches 47°C.3 A temperature of 47°C for 1 minute can impair implant osseointegration. The current standard of care involves the use of external irrigation to reduce heat generation during the drilling process. However, this method has limitations including poor visibility of surgical site, uneven cooling at the drill-bone interface, and inability to directly cool in guided surgery.\n\nTo address these concerns, recent innovations include surgical guides with integrated irrigation channels, which direct cooling fluid more efficiently to the drilling site and may reduce the risk of heat-induced bone injury. However, clinical evidence supporting the superiority of these advanced irrigation guides over traditional designs is still limited, highlighting the need for further research to optimize both surgical safety and outcomes.\n\nThis study aims to evaluate the effectiveness of an internal irrigation surgical guide system in reducing heat generation during osteotomy and improving outcomes of dental implant surgery. The findings from this study could inform clinical practice and contribute to the development of safer, more effective implant placement protocols.",[19,20,21,22],"Dental Implant Healing","Partial Edentulism Class 1","Partial Edentulism Class II","Partial Edentulism Class 3",[24,25],"dental implant surgery","dental implant placement","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},40,"ESTIMATED",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","Irrigation-Integrated Surgical Guide","Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.",[36],{"type":35,"name":40,"description":41,"armGroupLabels":42},"Conventional Surgical Guide","Conventional guided implant osteotomy using external sterile saline irrigation.",[43],"Conventional Surgical Guide With External Irrigation",[45],{"measure":46,"description":47,"timeFrame":48},"Early Implant Failure","Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.","From implant placement through 6 months postoperatively",[50,54,58,61],{"measure":51,"description":52,"timeFrame":53},"Early Marginal Bone Level Change","Change in marginal bone level measured on standardized periapical radiographs relative to the implant platform.","Implant placement, approximately 3 months postoperatively, and 6 months postoperatively",{"measure":55,"description":56,"timeFrame":57},"Peri-implant Radiolucency","Presence or absence of radiographic radiolucency surrounding the dental implant.","Through 6 months postoperatively",{"measure":59,"description":60,"timeFrame":57},"Persistent Peri-implant Pain or Suppuration","Number and percentage of implant sites demonstrating persistent pain or suppuration during postoperative follow-up.",{"measure":62,"description":63,"timeFrame":64},"Clinician-Reported Ease of Use","Clinician assessment of the ease of use, efficiency, and perceived benefit of the assigned surgical guide using a standardized postoperative questionnaire.","Immediately after implant placement","ALL","25 Years","75 Years",true,{"inclusion":70,"exclusion":71,"raw_text":72},[],[],"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",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"city":79,"state":80,"zip":81,"country":82,"geoPoint":83},"University of Maryland School of Dentistry","Baltimore","Maryland","21201","United States",{"lat":84,"lon":85},39.29038,-76.61219,[87,92],{"name":88,"role":89,"phone":90,"email":91},"Radi Masri","CONTACT","410 706 8133","rmasri@umaryland.edu",{"name":93,"role":89,"phone":94,"email":95},"Hanae Saito","410 706 3646","hsaito@umaryland.edu",[],[],[],{"nct_id":4,"conditions":100,"biomarkers":103},[101,102],"Dental Implant","Partial edentulism",[],{"nct_id":4,"found":68,"summary":105,"prompt_version":115},{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This interventional study plans to enroll 40 participants to compare two different surgical guides for dental implant placement.","completed","Internal Irrigation Surgical Guide for Dental Implants","This study is looking at a new way to place dental implants using an \"Irrigation-Integrated Surgical Guide.\" This guide delivers sterile saline (a salt water solution) directly to the area where the implant is being placed, aiming to reduce heat that can harm bone. This is compared to the \"Conventional Surgical Guide,\" which uses external irrigation. The study wants to see if the new guide helps prevent early implant failure, which will be checked for up to 6 months after the implant is placed. You might be able to join if you are between 25 and 75 years old, need a dental implant, and have enough bone for placement. The study is currently unclear on its recruitment status and plans to enroll 40 people.","Participants will be followed from implant placement through 6 months postoperatively to check for early implant failure.",124,"Not specified in the trial record.","Not stated in the trial record.",[36,40],"v2"]