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Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial
Sponsor: Agnaldo Rocha de Souza Junior
Summary
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/β-TCP; 70:30 ratio). Participants 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.
Official title: Randomized Clinical Trial Comparing Prophylactic Antibiotic Therapy and Placebo in Intraoral Alveolar Bone Grafting Procedures.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-02
Completion Date
2027-08
Last Updated
2025-12-29
Healthy Volunteers
Yes
Interventions
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.
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).
Locations (1)
Universidade Estadual de Montes Claros - Unimontes
Montes Claros, Minas Gerais, Brazil