Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAgnaldo Rocha de Souza Junior

About this trial

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.

Eligibility criteria

Qualifiers

Age between 18 and 65 years.

Disqualifiers

Presence of uncontrolled systemic diseases or chronic use of immunosuppressive medications.

Trial design

Treatments tested in this trial

  • Amoxicillin 500 mg (prophylactic regimen)
  • Placebo Capsule (matched dosing schedule)

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Agnaldo Rocha de Souza Junior

Lead sponsor

Universidade Estadual de Montes Claros

Sponsor institution