[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615722":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":62,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Universidade Estadual de Montes Claros","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amoxicillin Prophylaxis Group","ACTIVE_COMPARATOR","Amoxicillin 500 mg 1 hour before surgery, followed by 500 mg every 8 hours for 7 days. In case of penicillin allergy, azithromycin 500 mg 1 hour before surgery followed by 500 mg once daily for 3 days.",[13],"Drug: Amoxicillin 500 mg (prophylactic regimen)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Placebo capsules identical in appearance to the active medication. Dosing schedule matches the amoxicillin regimen: one capsule administered 1 hour preoperatively, followed by capsules every 8 hours for 7 days. For participants with documented penicillin allergy, placebo capsules will follow the azithromycin schedule (one dose preoperatively and one capsule daily for 3 days).",[19],"Drug: Placebo Capsule (matched dosing schedule)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Amoxicillin 500 mg (prophylactic regimen)","Amoxicillin 500 mg administered 1 hour before surgery, followed by 500 mg every 8 hours for 7 days. Participants with documented penicillin allergy will receive azithromycin 500 mg 1 hour before surgery, followed by 500 mg once daily for 3 days.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Capsule (matched dosing schedule)","Participants will receive placebo capsules identical in appearance to the active medication, containing no active drug. One placebo capsule will be administered 1 hour before surgery, followed by placebo capsules every 8 hours for 7 days, matching the amoxicillin dosing schedule. Participants with documented penicillin allergy randomized to the placebo group will receive placebo capsules matching the azithromycin schedule (one dose preoperatively and one capsule daily for 3 days).",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Agnaldo Rocha de Souza Junior, DDS, MSc, PhD","CONTACT","+55 (38) 984133929","agnaldo.junior@unimontes.br",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Universidade Estadual de Montes Claros - Unimontes","Montes Claros","Minas Gerais","39401-8321","Brazil","BR",{"type":46,"coordinates":47},"Point",[48,49],-43.86167,-16.735,{"lat":49,"lon":48},[52,55,57,60],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":36},"Agnaldo R. Souza Junior, DDS, MS, PhD","+55 (38) 98413-3929",{"name":33,"role":56,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"João Gabriel Souza, DDS, MSc, PhD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":26,"phoneExt":26,"email":26},"Jamil Shibli, DDS, MSc, PhD",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Agnaldo Rocha de Souza Junior","Sponsor-Investigator, DDS, MSc, PhD","100615722","antibiotic-prophylaxis-versus-placebo-in-alveolar-bone-grafting-a-randomized-controlled-trial-100615722",false,"NCT07296302","Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial","Randomized Clinical Trial Comparing Prophylactic Antibiotic Therapy and Placebo in Intraoral Alveolar Bone Grafting Procedures.","ABXGRAFT","Inclusion Criteria:\n\n* Age between 18 and 65 years.\n\nGenerally healthy individuals classified as American Society of Anesthesiologists (ASA) physical status I or II ( ASA I or ASA II).\n\nIndication for tooth extraction followed by alveolar bone grafting in a fresh socket.\n\nAbsence of active infection at the surgical site.\n\nWillingness to take amoxicillin or, in cases of β-lactam antibiotic allergy, azithromycin.\n\nNo use of antibiotics in the previous 30 days.\n\nAgreement to participate and signature of the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Presence of uncontrolled systemic diseases or chronic use of immunosuppressive medications.\n\nPregnancy or breastfeeding.\n\nSevere liver disease.\n\nSmoking more than 10 cigarettes per day.\n\nKnown allergy to macrolides (azithromycin).\n\nPrior use of antibiotics within the last 30 days.\n\nConcomitant use of medications with known risk of QT interval prolongation.\n\nSigns of acute infection at the extraction site.",true,"ALL","18 Years","65 Years",{"count":79,"type":80},150,"ESTIMATED","INTERVENTIONAL",[83],"NA","Tooth extraction sites often require alveolar bone grafting to preserve ridge dimensions and improve conditions for future implant placement. Although systemic antibiotic prophylaxis is commonly prescribed after grafting procedures, there is limited evidence supporting its necessity in healthy patients undergoing intraoral bone grafting. This randomized, double-blind, placebo-controlled clinical trial aims to compare the effects of prophylactic amoxicillin versus placebo on postoperative outcomes in alveolar bone graft procedures using Plenum® Oss HP biomaterial, a synthetic biphasic bioceramic composed of hydroxyapatite and beta-tricalcium phosphate (HA\u002Fβ-TCP; 70:30 ratio).\n\nParticipants will be randomly assigned to receive either amoxicillin 500 mg every 8 hours for 7 days or a matching placebo. Clinical parameters, postoperative complications, and patient-reported outcomes will be assessed. The study seeks to determine whether antibiotic prophylaxis provides measurable clinical benefits or whether placebo yields comparable results, contributing to more rational antibiotic use and supporting antimicrobial stewardship in oral surgery.",[86,87,88],"Alveolar Ridge Augmentation","Bone Grafting","Antibiotic Prophylaxis",[90,91,88,92,93],"Ridge Preservation","Alveolar Bone Graft","Synthetic Bone Graft","Biphasic Calcium Phosphate","NOT_YET_RECRUITING","2025-12-20",{"date":97,"type":98},"2025-12-29","ACTUAL",{"date":100,"type":80},"2026-02",{"date":102,"type":80},"2027-08",{"name":64,"class":6},1]