Randomized Clinical Trial Comparing Prophylactic Antibiotic Therapy and Placebo in Intraoral Alveolar Bone Grafting Procedures.

Alveolar bone grafting plays a central role in modern oral rehabilitation by preserving vertical and horizontal dimensions of the alveolar ridge following tooth extraction. The procedure is fundamental for optimizing future implant placement, reducing the need for additional regenerative surgeries, and improving long-term functional and esthetic outcomes. Despite its widespread use, postoperative management varies substantially among clinicians, particularly concerning the prescription of systemic antibiotic prophylaxis. Although antibiotics are often used empirically to prevent postoperative infection and graft failure, current scientific evidence remains inconclusive regarding their real benefit in healthy patients undergoing intraoral grafting under controlled aseptic conditions.

Antibiotic overprescription has important implications. Globally, antibiotic resistance is recognized as one of the most serious public health threats. Misuse of antibiotics in dentistry contributes significantly to this problem, especially when they are prescribed in situations where clinical benefit has not been firmly established. Additionally, unnecessary antibiotic use exposes patients to risks of adverse reactions, gastrointestinal disturbances, allergies, drug interactions, and increased treatment costs. In the specific context of alveolar bone grafts, the low incidence of postoperative infections reported in the literature raises questions about whether routine antibiotic prophylaxis is truly necessary.

This randomized, double-blind, placebo-controlled clinical trial was designed to rigorously evaluate whether postoperative amoxicillin provides measurable clinical, microbiological, or regenerative benefits compared with placebo in patients undergoing alveolar bone grafting using Plenum® OssHP, a synthetic biphasic bioceramic composed of hydroxyapatite and beta-tricalcium phosphate (HA/β-TCP; 70:30 ratio). The biomaterial is used in regenerative dentistry due to its osteoconductive properties and long-term volumetric stability. Its predictable behavior offers an ideal experimental environment to assess whether antibiotics influence early healing, infection rates, or the quality of regenerated bone.

Participants aged 18 years and older who require alveolar ridge preservation or augmentation with Plenum® Oss HP following tooth extraction will be recruited and screened according to the protocol approved by the Research Ethics Committee. After signing informed consent, eligible subjects will be randomly assigned in a 1:1 ratio to either the antibiotic group or the placebo group. Randomization will be stratified to reduce selection bias, and both participants and investigators will remain blinded throughout the study period. Individuals in the intervention group will receive amoxicillin 500 mg every 8 hours for 7 days, whereas the placebo group will receive identical capsules without active drug.

Surgical procedures will follow a standardized protocol, including atraumatic extraction when applicable, careful debridement of the alveolus, biomaterial placement, and tension-free flap closure. Postoperative care instructions and rescue medication protocols will be identical for all participants. Follow-up evaluations will occur at 7, 14, and 30 days, and again at 6 months during the re-entry procedure, allowing for multiple types of outcome assessment.