[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646188":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":41,"locations":47,"responsibleParty":67,"collaborators":35,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":35,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":105,"whyStopped":35,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Baghdad","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard-dose rhBMP-2","EXPERIMENTAL","Participants will receive local application of the standard dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) into the implant osteotomy immediately before dental implant placement.",[13],"Biological: Standard-dose rhBMP-2",{"label":15,"type":10,"description":16,"interventionNames":17},"Micro-dose rhBMP-2","Participants will receive local application of a micro-dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) into the implant osteotomy immediately before dental implant placement.",[18],"Biological: Micro-dose rhBMP-2",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo Control","PLACEBO_COMPARATOR","Participants will receive sterile normal saline applied into the implant osteotomy immediately before dental implant placement as the placebo control.",[24],"Drug: Sterile Normal Saline",[26,32,36],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Standard-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) is locally applied into the implant osteotomy immediately before implant placement at the manufacturer's recommended dose to enhance osseointegration and implant stability.",[9],[31],"Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)",{"type":27,"name":15,"description":33,"armGroupLabels":34,"otherNames":35},"Micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) is locally applied into the implant osteotomy immediately before implant placement at a reduced dose to evaluate whether comparable implant stability can be achieved with fewer dose-related adverse effects.",[15],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"DRUG","Sterile Normal Saline","Sterile normal saline is locally applied into the implant osteotomy immediately before implant placement as the placebo control.",[20],[42],{"name":43,"role":44,"phone":45,"phoneExt":35,"email":46},"omer Alhashimi, M.SC.","CONTACT","+9647733380409","omerdentist2@gmail.com",[48],{"facility":49,"status":35,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Dr. Mahdi Dental Clinic","Baghdad","Baghdad Governorate","10001","Iraq","IQ",{"type":56,"coordinates":57},"Point",[58,59],44.40088,33.34058,{"lat":59,"lon":58},[62,63,64],{"name":43,"role":44,"phone":45,"phoneExt":35,"email":46},{"name":35,"role":44,"phone":35,"phoneExt":35,"email":46},{"name":65,"role":66,"phone":35,"phoneExt":35,"email":35},"Omer AL-Hashimi, M.SC.","PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Omer Tareq Mohammed","Dentist, M.Sc. in Advanced Oral Surgery and Implantology, University of Bari Aldo Moro, Italy","100646188","standard--and-micro-dose-rhbmp-2-for-implant-stability-marginal-bone-loss-and-postoperative-sequelae-a-double-blind-randomized-controlled-trial-100646188",false,"NCT07696299","Standard- and Micro-Dose rhBMP-2 for Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial","Comparative Evaluation of Standard- and Micro-Dose Recombinant Human BMP-2 on Implant Stability, Marginal Bone Loss, and Postoperative Sequelae: A Double-Blind Randomized Controlled Trial","SMBMP","Inclusion Criteria:\n\n* Patients aged 20 to 55 years requiring a single dental implant for a single tooth missing in the posterior mandible (strictly limited to one implant per patient to prevent clustering effects and intra-subject correlation).\n\nPatients must be systemically healthy or medically well-controlled, categorized as ASA I or ASA II according to the American Society of Anesthesiologists classification.\n\nSurgical sites must exhibit D2 or D3 bone quality with adequate residual alveolar bone volume (minimum 6 mm width and 10 mm height).\n\nPatients must maintain optimal oral hygiene, suitable for a prosthetically driven implant treatment workflow.\n\nExclusion Criteria:\n\n* Patients presenting with uncontrolled systemic conditions (e.g., unmanaged diabetes mellitus, active osteoporosis).\n\nA history of radiotherapy or chemotherapy in the maxillofacial region. Current heavy smoking habits (\\>10 cigarettes per day). Active and untreated periodontal disease. Pregnancy or lactation.","ALL","20 Years","55 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","This study will compare the effect of standard-dose and micro-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) with a placebo control on dental implant stability in the posterior mandible. Sixty patients requiring a single dental implant will be randomly assigned to one of three groups: standard-dose rhBMP-2, micro-dose rhBMP-2, or sterile saline only. Implant stability will be measured using Resonance Frequency Analysis at baseline, 2 weeks, 4 weeks, and 12 weeks. Marginal bone loss, peri-implant bone density, ectopic bone formation, and postoperative sequelae including swelling, pain, trismus, and soft tissue healing will also be evaluated during follow-up. The aim is to determine whether micro-dose rhBMP-2 can improve implant stability while reducing postoperative complications compared with the standard dose.",[89,90,91],"Tooth Loss \u002F Rehabilitation","Dental Implant","Osseo-Integrated Implants",[93,94,90,95,96,97,98,99,100,101,102,103,104],"rhbmp-2","Recombinant Human Bone Morphogenetic Protein-2","Implant Stability","Micro-dose","Standard-dose","Osstell","Resonance Frequency Analysis","ISQ","Marginal Bone Loss","Peri-implant Bone Density","Posterior Mandible","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-06",{"date":108,"type":109},"2026-07-10","ACTUAL",{"date":111,"type":83},"2026-12",{"date":113,"type":83},"2028-12",{"name":5,"class":6},1]